An interventional study of Parent Training Intervention in Deafness, Hearing Loss and Parenting, sponsored by Christina Studts. Active, not recruiting at 1 site in United States. Open to participants aged 3 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Christina Studts · Not applicable, Interventional, and Prevention
Children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This project will systematically adapt an evidence-based parent training intervention to increase its acceptability and relevance for parents of young DHH children. Effectiveness of the adapted intervention and its implementation with parents of young DHH children followed in "real world" hearing healthcare clinics will be assessed.
Aim 1: This part of the study convened a Community Advisory Board for input on the study. CAB members were considered collaborators rather than research subjects. They provided no personal data for use in publications or other research dissemination efforts. No adverse event data related to the CAB were collected.
Aim 2: This part of the study involved qualitative interviews with parents and focus groups with stakeholders (speech-language pathologists, audiologists, and teachers of the Deaf) to guide the adaptation of the intervention. There was no intervention in this aim and it was not a clinical trial. No adverse event data related to the qualitative interviews were collected.
Aim 3: Please see Record NCT03483428 for details and results of Aim 3.
Aim 4: This part of the study was a randomized controlled trial of the adapted parent training intervention. Parents of DHH children were randomized to either receive the intervention or to a control condition.
Aim 5: This part of the study is collecting process data about how the intervention was delivered in Aim 4, as well as qualitative data regarding perspectives about the intervention from key stakeholders, including a subset of parents from Aim 4, the interventionists who delivered the intervention, and other stakeholders. There is no intervention in this aim and it is not a clinical trial. No adverse event data will be collected.
160 studies on the registry are indexed under Deafness; 46 are open to participants now.
This study's enrollment of 295 is above the median of 43 across 106 interventional studies indexed under Deafness.
Browse Deafness studies →Christina Studts is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Parents are offered a evidence-based behavioral parent training intervention systematically adapted for parents of young deaf and hard of hearing children. The intervention is offered annually and includes up to 6 sessions each year.
Behavioral: Parent Training Intervention
Parents are not offered the intervention but are not precluded from accessing other services for their young deaf and hard of hearing chidren.
Adapted version of the Family Check-Up/Everyday Parenting intervention
Parenting Young Children (PARYC) Scale Total Score
On the Parenting Young Children (PARYC) scale, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Total Score is the sum of three subscale scores (Supporting Positive Behaviors, Setting Limits, Proactive Parenting) and can range from 21-147 with higher scores indicating more positive parenting practices.
Time frame: 6 months after parent baseline
Change in Parenting Young Children Scale (PARYC) Total Scores Over Time
While the primary study outcome is PARYC Total scores 6 months after baseline, a secondary outcome is PARYC Total scores over time within and between study arms for up to 3 years. On the PARYC, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Total Score is the sum of three subscale scores (Supporting Positive Behaviors, Setting Limits, Proactive Parenting) and can range from 21-147 with higher scores indicating more positive parenting practices.
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Change in Parenting Young Children Scale (PARYC) Supporting Positive Behavior Subscale Scores Over Time
On the PARYC, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Supporting Positive Behavior subscale sums scores from 7 items describing this positive parenting strategy. The subscale score can range from 7-49 with higher scores indicating more use of strategies to support their child's positive behavior.
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Change in Parenting Young Children Scale (PARYC) Setting Limits Subscale Scores Over Time
On the PARYC, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Setting Limits subscale sums scores from 7 items describing this positive parenting strategy. The subscale score can range from 7-49 with higher scores indicating more use of strategies to set limits.
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Change in Parenting Young Children Scale (PARYC) Proactive Parenting Subscale Scores Over Time
On the PARYC, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Proactive Parenting subscale sums scores from 7 items describing this positive parenting strategy. The subscale score can range from 7-49 with higher scores indicating more use of proactive parenting strategies.
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Child Behavior Checklist (CBCL) Total Problems T-Score
Child Behavior Checklist (CBCL) Total Problems T-scores, including responses to all items. Parents of children ages 3-5 completed the CBCL/1-5 and parents of children ages 6 and up completed the CBCL/6-18. T-scores have a population mean of 50 with a standard deviation of 10. Higher T-scores indicate higher levels of behavioral problems. On the CBCL/1-5 and CBCL/6-18, T-scores less than 60 are in the normal range. For children ages 3-5 years, T-scores from 60-63 are in the at-risk/borderline range and T-scores 64 and above are in the clinical range. For children ages 6 years and up, T-scores from 60-64 are in the at-risk/borderline range and T-scores 65 and above are in the clinical range.
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Child Behavior Checklist (CBCL) Internalizing Problems T-Score
Child Behavior Checklist (CBCL) Internalizing Problems subscale T-scores. Parents of children ages 3-5 completed the CBCL/1-5 (99 items) and parents of children ages 6 and up completed the CBCL/6-18 (113 items). T-scores have a population mean of 50 with a standard deviation of 10. Higher T-scores indicate higher levels of internalizing behavior problems. T-scores less than 60 are in the normal range. For children ages 3-5 years, T-scores from 60-63 are in the at-risk/borderline range and T-scores 64 and above are in the clinical range. For children ages 6 years and up, T-scores from 60-64 are in the at-risk/borderline range and T-scores 65 and above are in the clinical range.
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Child Behavior Checklist (CBCL) Externalizing Problems T-Score
Child Behavior Checklist (CBCL) Externalizing Problems subscale T-scores. Parents of children ages 3-5 completed the CBCL/1-5 (99 items) and parents of children ages 6 and up completed the CBCL/6-18 (113 items). T-scores have a population mean of 50 with a standard deviation of 10. Higher T-scores indicate higher levels of externalizing behavioral problems. T-scores less than 60 are in the normal range. For children ages 3-5 years, T-scores from 60-63 are in the at-risk/borderline range and T-scores 64 and above are in the clinical range. For children ages 6 years and up, T-scores from 60-64 are in the at-risk/borderline range and T-scores 65 and above are in the clinical range.
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Parent Sense of Competence Scale (PSCS) Total Score
Parent Sense of Competence Scale (PSCS) Total Score combines the scores for the self-efficacy and satisfaction subscales, yielding a total score for parent sense of competence. Possible scores range from 16-96 with higher scores indicating higher levels of parent sense of competence.
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment.
Parent Sense of Competence Scale (PSCS) Self-efficacy Score
The Parent Sense of Competence Scale Self-efficacy subscale score measures parents' self-efficacy in the parenting role. Possible scores range from 7-42 with higher scores indicating higher levels of parent self-efficacy.
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Parent Sense of Competence Scale (PSCS) Satisfaction Score
The Parent Sense of Competence Scale (PSCS) Satisfaction subscale measures parent satisfaction with the parenting role. Possible scores range from 9-54 with higher scores indicating higher levels of parent satisfaction.
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory-II is a self-report measure of depressive symptoms. For each of 21 items, respondents select the response option (scored 0, 1, 2, or 3) closest to their own experience over the past week. Scores can range from 0-63 with higher scores indicating more/more severe depressive symptoms.
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Parent Child Interaction System (PARCHISY) - Parent Positive Control
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Positive Control score reflects parents' use of positive behaviors (e.g., use of explanation, open-ended prompting, praise) in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating more use of positive behaviors by parents.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Parent Negative Control
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Negative Control score reflects parents' use of negative behaviors (e.g., use of physical control, criticism) in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating more use of negative behaviors by parents.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Parent Positive Affect
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Positive Affect score reflects parents' positive affect (e.g., warmth, smiling, laughing) in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of positive affect observed in parents.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Parent Negative Affect
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Negative Affect score reflects parents' negative affect (e.g., rejection, frowning, cold/harsh voice) in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of negative affect observed in parents.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Positive Affect
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Positive Affect score reflects children's positive affect (e.g., warmth, smiling, laughing) in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of positive affect observed in children.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Negative Affect
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Negative Affect score reflects children's negative affect (e.g., rejection, cold/harsh voice tones) in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of negative affect observed in children.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child On-Task
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child On-Task score reflects parents' children's initiative and persistence in engaged with the assigned task while interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of children's observed on-task behavior.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Noncompliance
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Noncompliance score reflects children's level of compliance while interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child noncompliance.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Conflict
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Conflict score reflects parent-child dyads' level of minor or major disagreement (e.g., shared negative affect, arguing, tussling over toy, etc.) in interacting with each other. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of conflict.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Motivation Inventory (PMI) Total Score
The Parent Motivation Inventory (PMI) is a self-report measure of parents' motivation to change parenting behaviors. The Total Score is the sum of the 3 subscales (Desire for Change, Readiness to Change, Perceived Ability to Change). Total scores can range from 25 to 125 with higher scores indicated higher motivation to change.
Time frame: Annually from 12 months after baseline up to 36 months after baseline
Parent Motivation Inventory (PMI) Desire for Change Subscale
The Parent Motivation Inventory (PMI) is a self-report measure of parents' motivation to change parenting behaviors. The Desire for Change subscale includes 7 items measuring parents' desire for their child's behaviors to change. Subscale scores can range from 7 to 35 with higher scores indicated higher desire.
Time frame: Annually from 12 months after baseline up to 36 months after baseline
Parent Motivation Inventory (PMI) Readiness to Change Subscale
The Parent Motivation Inventory (PMI) is a self-report measure of parents' motivation to change parenting behaviors. The Readiness to Change subscale includes 14 items measuring parents' readiness to change their parenting behaviors. Subscale scores can range from 14 to 70 with higher scores indicated higher readiness to change.
Time frame: Annually from 12 months after baseline up to 36 months after baseline
Parent Motivation Inventory (PMI) Perceived Ability to Change Subscale
The Parent Motivation Inventory (PMI) is a self-report measure of parents' motivation to change parenting behaviors. The Perceived Ability to Change subscale includes 4 items measuring parents' perceived ability to change their parenting behaviors. Subscale scores can range from 4 to 20 with higher scores indicated higher perceived ability to change.
Time frame: Annually from 12 months after baseline up to 36 months after baseline
Hearing Aid Adherence Questionnaire
The Hearing Aid Adherence Questionnaire is a parent-report measure assessing their child's use of their hearing aids. This measure includes a list of 9 situations (e.g., riding in a car, being at someone else's house) for which parents rate the frequency of their child's hearing aid use on a Likert-type scale from 1 (never) to 5 (always). The scale score is the mean of the parent's responses to each item. Scores can range from 1-5 and higher scores indicate more hearing aid use in more situations.
Time frame: Every 12 months from completion of baseline assessment up to 36 months after baseline assessment
Therapy Attitude Inventory (TAI)
The Therapy Attitude Inventory is a parent-report measure evaluating parent satisfaction with therapy (developed for use with Parent-Child Interaction Therapy; in this study used to assess satisfaction with the adapted Behavioral Parent Training intervention). Parents rate their agreement with 10 items using a Likert-type scale (1-5) for each item. Scores can range from 10 to 50 with higher scores indicating more satisfaction.
Time frame: Annually from 6 months after baseline up to 30 months after baseline
MacArthur Bates Communicative Development Inventories - Words & Sentences - Words Produced (Raw Score)
The MacArthur Bates Communicative Development Inventories - Words \& Sentences - Words Produced section assesses the number of words currently spontaneously used by a child via parent-report. Raw scores can range from 0-680 with higher scores indicating more words produced by a child.
Time frame: Annually from baseline through up to 36 months.
MacArthur Bates Communicative Development Inventories - Words & Sentences - Sentence Complexity Score
The MacArthur Bates Communicative Development Inventories - Words \& Sentences - Sentence Complexity Score assesses grammatical development by having parents review 37 pairs of sentences. For each pair, the parent selects the sentence that sounds more like their child's speech. One point is added for each selection of the more complex sentence in a pair. Sentence Complexity Scores can range from 0-37 with higher scores indicating higher levels of grammatical development.
Time frame: Annually from baseline through up to 36 months.
Peabody Picture Vocabulary Test (PPVT) Standard Score
The Peabody Picture Vocabulary Test (PPVT) Standard Score is a measure of a child's receptive language. The PPVT assesses receptive vocabulary by requiring children to identify one of four pictures corresponding to a spoken word. Administration follows standardized basal and ceiling procedures. Standard scores are derived with the standard score metric (M = 100, SD = 15) and higher scores indicate higher levels of receptive vocabulary.
Time frame: Annually from baseline assessment through up to 36 months after baseline
Clinical Evaluation of Language Fundamentals (CELF) - Core Language Score (Standard Scores)
The Clinical Evaluation of Language Fundamentals - Core Language Score (CELF-CLS) assesses language ability. The CELF is an individually administered standardized language assessment that assesses performance across multiple expressive and receptive language subtests. Age-appropriate versions of the CELF were administered (i.e., the CELF-Preschool-3 for children ages 3 and 4 years; the CELF-5 for children ages 5 years and up). On both versions of the CELF, the CLS is a composite score derived from subsets of language subtests appropriate for the child's age, estimating overall language ability by combining receptive and expressive language skills. The CLS standard score has a mean of 100 and standard deviation of 15. Interpretation of CLS standard scores: 130 or higher = very superior; 120-129 = superior; 110-119 = high average; 90-109 = average; 80-89 = low average; 70-79 = moderately low; less than 70 = very low. Higher scores indicate higher levels of language ability.
Time frame: Annually from baseline through up to 36 months after baseline
Beginner's Intelligibility Test (BIT)
The Beginner's Intelligibility Test (BIT) assesses the intelligibility of 10 sentences repeated by a child in response to the test administrator speaking the sentence and showing a picture illustrating the sentence. The child's spoken sentences are audiorecorded and played for 3 naive listeners who write down what they heard. The BIT score is calculated as the mean percentage of opportunity words (the original words spoken by the test administrator) identified across the 3 listeners. Scores can range from 0 to 100.
Time frame: Every 6 months beginning with baseline through up to 36 months
Meaningful Auditory Integration Scale (MAIS) - Bonding/Attachment to Hearing Device Domain
The Meaningful Auditory Integration Scale - Bonding/Attachment to Hearing Device domain of the MAIS assesses to what degree a child seeks out or depends on their hearing device. Two interview questions are asked of the parent (one about child wearing the device, one about child's response when the device is non-functional) and parent responses are coded from 0 (Never) to 4 (Always). The sum of the coded responses is the score, which can range from 0-8, with higher scores indicating better bonding/attachment to the hearing device.
Time frame: Annually from baseline through up to 36 months
Clinical Evaluation of Language Fundamentals (CELF) - Expressive Language Index (Standard Scores)
The Clinical Evaluation of Language Fundamentals - Expressive Language Index (CELF-ELI) assesses expressive language. The CELF is an individually administered standardized language assessment that assesses performance across multiple expressive and receptive language subtests. Age-appropriate versions of the CELF were administered (i.e., the CELF-Preschool-3 for children ages 3 and 4 years; the CELF-5 for children ages 5 years and up). On both versions of the CELF, the ELI is a composite score derived from subsets of expressive language subtests appropriate for the child's age. The ELI standard score has a mean of 100 and standard deviation of 15. Interpretation of ELI standard scores: 130 or higher = very superior; 120-129 = superior; 110-119 = high average; 90-109 = average; 80-89 = low average; 70-79 = moderately low; less than 70 = very low. Higher scores indicate higher levels of expressive language ability.
Time frame: Annually from baseline through up to 36 months after baseline
Parent Child Interaction System (PARCHISY) - Parent Responsiveness
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Responsiveness score reflects parents' responsiveness (verbal or behavioral) to their child's questions, comments, and behaviors in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of parent responsiveness.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Parent On-Task
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent On-Task score reflects parents' initiative and persistence in engaging with the assigned task while interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of parents' observed on-task behavior.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Parent Verbalizations
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Verbalizations score reflects parents' amount of verbalizations in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of parent verbalizations.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Responsiveness
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Responsiveness score reflects children's responsiveness (verbal or behavioral) to their parent's questions, comments, and behaviors in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child responsiveness.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Autonomy
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Autonomy score reflects children's autonomy/independence (e.g., leads and controls task - but does not include off-task behaviors) in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child autonomy.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Activity
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Activity score reflects children's level of physical movements (e.g., moving arms, jumping up and down) in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child activity.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Verbalizations
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Verbalizations score reflects children's amount of verbalizations in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child verbalizations.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Reciprocity
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Reciprocity score reflects parent-child dyads' level of reciprocity (e.g., shared positive affect, eye contact, turn-taking quality) in interacting with each other. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of reciprocity.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Cooperation
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Cooperation score reflects parent-child dyads' level of explicit agreement/discussion of how to complete the task together (e.g., "Shall we do this next?" "Yes") in interacting with each other. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of cooperation.
Time frame: Every 6 months from baseline to up to 18 months after baseline
Aim 2 participants were recruited for parent interviews and stakeholder focus groups. Participant recruitment for the Aim 4 clinical trial began in June 2021 and ended in April 2024. Recruitment for Aim 5 is still active.
| Milestone | Aim 2 Interviews and Focus Groups for Intervention Adaptation | Aim 4 Behavioral Parent Training | Aim 4 Control | Aim 5 Implementation Data |
|---|---|---|---|---|
| Started | 35 | 0 | 0 | 0 |
| Completed | 35 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Aim 2 Interviews and Focus Groups for Intervention Adaptation | Aim 4 Behavioral Parent Training | Aim 4 Control | Aim 5 Implementation Data |
|---|---|---|---|---|
| Started | 0 | 142 | 108 | 0 |
| Completed | 0 | 124 | 106 | 0 |
| Not completed | 0 | 18 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 8 | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 10 | 0 | 0 |
| Milestone | Aim 2 Interviews and Focus Groups for Intervention Adaptation | Aim 4 Behavioral Parent Training | Aim 4 Control | Aim 5 Implementation Data |
|---|---|---|---|---|
| Started | 0 | 0 | 0 | 28 |
| Completed | 0 | 0 | 0 | 26 |
| Not completed | 0 | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 2 |
On the Parenting Young Children (PARYC) scale, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Total Score is the sum of three subscale scores (Supporting Positive Behaviors, Setting Limits, Proactive Parenting) and can range from 21-147 with higher scores indicating more positive parenting practices.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Parenting Young Children (PARYC) Scale Total Score | 124.43 ± 13.98 | 116.22 ± 12.73 |
While the primary study outcome is PARYC Total scores 6 months after baseline, a secondary outcome is PARYC Total scores over time within and between study arms for up to 3 years. On the PARYC, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Total Score is the sum of three subscale scores (Supporting Positive Behaviors, Setting Limits, Proactive Parenting) and can range from 21-147 with higher scores indicating more positive parenting practices.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 116.92 ± 14.83 | 114.12 ± 15.27 |
| 6 months after baseline | 124.43 ± 13.98 | 116.22 ± 12.73 |
| 12 months after baseline | 123.34 ± 12.85 | 116.38 ± 14.39 |
| 18 months after baseline | 125.23 ± 13.03 | 116.76 ± 17.33 |
| 24 months after baseline | 118.68 ± 27.42 | 117.09 ± 21.21 |
| 30 months after baseline | 127.55 ± 16.66 | 120.85 ± 16.02 |
| 36 months after baseline | 127.85 ± 10.01 | 114.31 ± 21.40 |
On the PARYC, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Supporting Positive Behavior subscale sums scores from 7 items describing this positive parenting strategy. The subscale score can range from 7-49 with higher scores indicating more use of strategies to support their child's positive behavior.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 40.35 ± 6.45 | 40.74 ± 5.16 |
| 6 months after baseline | 41.72 ± 5.57 | 40.91 ± 4.48 |
| 12 months after baseline | 41.00 ± 4.79 | 40.31 ± 5.83 |
| 18 months after baseline | 42.66 ± 5.07 | 39.43 ± 6.93 |
| 24 months after baseline | 39.50 ± 10.35 | 40.63 ± 7.01 |
| 30 months after baseline | 42.14 ± 6.21 | 41.54 ± 6.16 |
| 36 months after baseline | 42.46 ± 5.95 | 38.08 ± 7.15 |
On the PARYC, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Setting Limits subscale sums scores from 7 items describing this positive parenting strategy. The subscale score can range from 7-49 with higher scores indicating more use of strategies to set limits.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 37.56 ± 6.14 | 36.60 ± 7.13 |
| 6 months after baseline | 40.35 ± 5.80 | 37.41 ± 5.06 |
| 12 months after baseline | 40.43 ± 5.37 | 37.31 ± 5.22 |
| 18 months after baseline | 40.54 ± 5.49 | 38.17 ± 6.19 |
| 24 months after baseline | 39.64 ± 9.50 | 37.60 ± 7.40 |
| 30 months after baseline | 43.00 ± 5.97 | 40.31 ± 5.88 |
| 36 months after baseline | 42.31 ± 4.37 | 38.00 ± 5.74 |
On the PARYC, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Proactive Parenting subscale sums scores from 7 items describing this positive parenting strategy. The subscale score can range from 7-49 with higher scores indicating more use of proactive parenting strategies.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 39.00 ± 5.36 | 36.78 ± 7.89 |
| 6 months after baseline | 42.36 ± 4.63 | 37.90 ± 6.10 |
| 12 months after baseline | 41.91 ± 4.99 | 38.77 ± 6.36 |
| 18 months after baseline | 42.03 ± 5.13 | 39.17 ± 6.40 |
| 24 months after baseline | 39.54 ± 8.27 | 38.86 ± 9.41 |
| 30 months after baseline | 42.41 ± 5.34 | 39.00 ± 8.85 |
| 36 months after baseline | 43.08 ± 5.28 | 38.23 ± 11.37 |
Child Behavior Checklist (CBCL) Total Problems T-scores, including responses to all items. Parents of children ages 3-5 completed the CBCL/1-5 and parents of children ages 6 and up completed the CBCL/6-18. T-scores have a population mean of 50 with a standard deviation of 10. Higher T-scores indicate higher levels of behavioral problems. On the CBCL/1-5 and CBCL/6-18, T-scores less than 60 are in the normal range. For children ages 3-5 years, T-scores from 60-63 are in the at-risk/borderline range and T-scores 64 and above are in the clinical range. For children ages 6 years and up, T-scores from 60-64 are in the at-risk/borderline range and T-scores 65 and above are in the clinical range.
| T-score | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 46.99 ± 10.18 | 48.13 ± 12.70 |
| 6 months after baseline | 46.12 ± 9.96 | 49.13 ± 11.53 |
| 12 months after baseline | 46.47 ± 10.26 | 47.92 ± 11.50 |
| 18 months after baseline | 45.78 ± 10.21 | 48.00 ± 13.80 |
| 24 months after baseline | 47.79 ± 9.89 | 52.00 ± 10.68 |
| 30 months after baseline | 47.57 ± 11.13 | 49.00 ± 10.73 |
| 36 months after baseline | 50.69 ± 10.84 | 49.77 ± 11.62 |
Child Behavior Checklist (CBCL) Internalizing Problems subscale T-scores. Parents of children ages 3-5 completed the CBCL/1-5 (99 items) and parents of children ages 6 and up completed the CBCL/6-18 (113 items). T-scores have a population mean of 50 with a standard deviation of 10. Higher T-scores indicate higher levels of internalizing behavior problems. T-scores less than 60 are in the normal range. For children ages 3-5 years, T-scores from 60-63 are in the at-risk/borderline range and T-scores 64 and above are in the clinical range. For children ages 6 years and up, T-scores from 60-64 are in the at-risk/borderline range and T-scores 65 and above are in the clinical range.
| T-score | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 45.34 ± 10.57 | 46.91 ± 11.46 |
| 6 months after baseline | 43.91 ± 10.63 | 47.52 ± 10.40 |
| 12 months after baseline | 43.77 ± 10.34 | 47.60 ± 11.07 |
| 18 months after baseline | 43.74 ± 9.52 | 46.32 ± 10.95 |
| 24 months after baseline | 44.43 ± 9.50 | 47.50 ± 10.05 |
| 30 months after baseline | 44.93 ± 10.69 | 44.75 ± 8.79 |
| 36 months after baseline | 47.85 ± 10.95 | 45.46 ± 9.46 |
Child Behavior Checklist (CBCL) Externalizing Problems subscale T-scores. Parents of children ages 3-5 completed the CBCL/1-5 (99 items) and parents of children ages 6 and up completed the CBCL/6-18 (113 items). T-scores have a population mean of 50 with a standard deviation of 10. Higher T-scores indicate higher levels of externalizing behavioral problems. T-scores less than 60 are in the normal range. For children ages 3-5 years, T-scores from 60-63 are in the at-risk/borderline range and T-scores 64 and above are in the clinical range. For children ages 6 years and up, T-scores from 60-64 are in the at-risk/borderline range and T-scores 65 and above are in the clinical range.
| T-score | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 46.45 ± 10.00 | 47.61 ± 12.21 |
| 6 months after baseline | 45.40 ± 10.26 | 48.59 ± 11.80 |
| 12 months after baseline | 45.95 ± 10.85 | 47.17 ± 10.77 |
| 18 months after baseline | 45.16 ± 10.02 | 46.95 ± 13.88 |
| 24 months after baseline | 48.50 ± 10.35 | 50.13 ± 10.51 |
| 30 months after baseline | 45.79 ± 11.57 | 47.88 ± 10.21 |
| 36 months after baseline | 48.54 ± 11.22 | 49.62 ± 10.50 |
Parent Sense of Competence Scale (PSCS) Total Score combines the scores for the self-efficacy and satisfaction subscales, yielding a total score for parent sense of competence. Possible scores range from 16-96 with higher scores indicating higher levels of parent sense of competence.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 42.62 ± 9.61 | 44.15 ± 12.14 |
| 6 months after baseline | 41.03 ± 10.31 | 43.71 ± 10.89 |
| 12 months after baseline | 40.23 ± 9.77 | 42.94 ± 9.65 |
| 18 months after baseline | 40.51 ± 10.33 | 40.60 ± 10.82 |
| 24 months after baseline | 39.64 ± 11.27 | 40.64 ± 9.55 |
| 30 months after baseline | 37.71 ± 11.57 | 39.25 ± 8.87 |
| 36 months after baseline | 38.31 ± 10.15 | 39.00 ± 10.66 |
The Parent Sense of Competence Scale Self-efficacy subscale score measures parents' self-efficacy in the parenting role. Possible scores range from 7-42 with higher scores indicating higher levels of parent self-efficacy.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 18.08 ± 4.88 | 19.37 ± 6.08 |
| 6 months after baseline | 17.42 ± 4.97 | 18.70 ± 5.77 |
| 12 months after baseline | 17.20 ± 5.24 | 18.40 ± 5.46 |
| 18 months after baseline | 17.52 ± 5.94 | 16.99 ± 4.45 |
| 24 months after baseline | 16.64 ± 4.67 | 17.44 ± 5.82 |
| 30 months after baseline | 15.21 ± 4.73 | 16.50 ± 5.97 |
| 36 months after baseline | 15.23 ± 5.56 | 16.54 ± 6.74 |
The Parent Sense of Competence Scale (PSCS) Satisfaction subscale measures parent satisfaction with the parenting role. Possible scores range from 9-54 with higher scores indicating higher levels of parent satisfaction.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 24.54 ± 6.71 | 24.78 ± 7.33 |
| 6 months after baseline | 23.61 ± 7.02 | 25.01 ± 6.75 |
| 12 months after baseline | 23.03 ± 6.13 | 24.54 ± 6.68 |
| 18 months after baseline | 22.99 ± 6.13 | 23.61 ± 7.14 |
| 24 months after baseline | 23.00 ± 7.82 | 23.20 ± 5.26 |
| 30 months after baseline | 22.50 ± 7.30 | 22.75 ± 4.77 |
| 36 months after baseline | 21.08 ± 5.27 | 22.46 ± 5.87 |
The Beck Depression Inventory-II is a self-report measure of depressive symptoms. For each of 21 items, respondents select the response option (scored 0, 1, 2, or 3) closest to their own experience over the past week. Scores can range from 0-63 with higher scores indicating more/more severe depressive symptoms.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 8.45 ± 8.74 | 8.94 ± 7.70 |
| 6 months after baseline | 7.73 ± 8.65 | 9.67 ± 8.82 |
| 12 months after baseline | 5.92 ± 7.71 | 8.79 ± 8.11 |
| 18 months after baseline | 4.72 ± 6.84 | 6.63 ± 7.11 |
| 24 months after baseline | 4.21 ± 5.79 | 5.50 ± 4.53 |
| 30 months after baseline | 6.07 ± 8.10 | 4.81 ± 4.67 |
| 36 months after baseline | 4.00 ± 4.65 | 4.54 ± 4.03 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Positive Control score reflects parents' use of positive behaviors (e.g., use of explanation, open-ended prompting, praise) in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating more use of positive behaviors by parents.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 5.78 ± 1.09 | 5.78 ± 1.06 |
| 6 months after baseline | 5.90 ± 1.03 | 5.90 ± 1.02 |
| 12 months after baseline | 5.42 ± 1.83 | 5.50 ± 1.05 |
| 18 months after baseline | 5.42 ± 1.38 | 4.82 ± 1.33 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Negative Control score reflects parents' use of negative behaviors (e.g., use of physical control, criticism) in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating more use of negative behaviors by parents.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 2.41 ± 1.37 | 2.09 ± 1.11 |
| 6 months after baseline | 2.04 ± 1.17 | 2.20 ± 1.44 |
| 12 months after baseline | 2.42 ± 1.80 | 2.67 ± 1.35 |
| 18 months after baseline | 1.83 ± 1.19 | 2.54 ± 1.13 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Positive Affect score reflects parents' positive affect (e.g., warmth, smiling, laughing) in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of positive affect observed in parents.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 6.04 ± 0.92 | 6.16 ± 0.96 |
| 6 months after baseline | 5.98 ± 1.13 | 6.06 ± 1.05 |
| 12 months after baseline | 5.54 ± 1.62 | 5.07 ± 1.22 |
| 18 months after baseline | 6.08 ± 1.38 | 4.54 ± 2.16 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Negative Affect score reflects parents' negative affect (e.g., rejection, frowning, cold/harsh voice) in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of negative affect observed in parents.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 1.56 ± 0.77 | 1.56 ± 0.90 |
| 6 months after baseline | 1.67 ± 1.00 | 1.76 ± 1.01 |
| 12 months after baseline | 1.92 ± 1.11 | 2.80 ± 1.52 |
| 18 months after baseline | 1.92 ± 1.38 | 3.27 ± 1.79 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Positive Affect score reflects children's positive affect (e.g., warmth, smiling, laughing) in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of positive affect observed in children.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 6.30 ± 0.90 | 6.16 ± 1.02 |
| 6 months after baseline | 6.21 ± 1.18 | 6.28 ± 0.95 |
| 12 months after baseline | 5.91 ± 1.04 | 5.97 ± 1.11 |
| 18 months after baseline | 6.17 ± 1.40 | 5.36 ± 1.63 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Negative Affect score reflects children's negative affect (e.g., rejection, cold/harsh voice tones) in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of negative affect observed in children.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 1.53 ± 0.90 | 1.50 ± 0.94 |
| 6 months after baseline | 1.64 ± 1.20 | 1.67 ± 1.11 |
| 12 months after baseline | 1.73 ± 0.90 | 1.83 ± 1.25 |
| 18 months after baseline | 1.83 ± 1.40 | 2.55 ± 1.75 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child On-Task score reflects parents' children's initiative and persistence in engaged with the assigned task while interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of children's observed on-task behavior.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 5.07 ± 1.38 | 5.33 ± 1.29 |
| 6 months after baseline | 5.44 ± 1.48 | 5.15 ± 1.16 |
| 12 months after baseline | 5.19 ± 1.65 | 4.93 ± 1.33 |
| 18 months after baseline | 5.25 ± 1.91 | 4.64 ± 1.43 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Noncompliance score reflects children's level of compliance while interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child noncompliance.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 1.92 ± 1.16 | 1.67 ± 0.81 |
| 6 months after baseline | 1.43 ± 0.90 | 1.62 ± 0.85 |
| 12 months after baseline | 1.39 ± 0.65 | 1.57 ± 0.82 |
| 18 months after baseline | 1.58 ± 1.51 | 1.36 ± 0.50 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Conflict score reflects parent-child dyads' level of minor or major disagreement (e.g., shared negative affect, arguing, tussling over toy, etc.) in interacting with each other. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of conflict.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 1.29 ± 0.68 | 1.18 ± 0.52 |
| 6 months after baseline | 1.16 ± 0.64 | 1.17 ± 0.44 |
| 12 months after baseline | 1.46 ± 1.21 | 1.47 ± 0.64 |
| 18 months after baseline | 1.33 ± 0.89 | 1.44 ± 0.53 |
The Parent Motivation Inventory (PMI) is a self-report measure of parents' motivation to change parenting behaviors. The Total Score is the sum of the 3 subscales (Desire for Change, Readiness to Change, Perceived Ability to Change). Total scores can range from 25 to 125 with higher scores indicated higher motivation to change.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 76.85 ± 21.26 | 83.50 ± 16.83 |
| 12 months after baseline | 67.06 ± 21.28 | 74.73 ± 18.92 |
| 24 months after baseline | 66.36 ± 24.78 | 63.19 ± 22.55 |
| 36 months after baseline | 59.15 ± 19.32 | 61.15 ± 20.34 |
The Parent Motivation Inventory (PMI) is a self-report measure of parents' motivation to change parenting behaviors. The Desire for Change subscale includes 7 items measuring parents' desire for their child's behaviors to change. Subscale scores can range from 7 to 35 with higher scores indicated higher desire.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 16.35 ± 7.46 | 17.70 ± 6.25 |
| 12 months after baseline | 15.14 ± 7.09 | 15.88 ± 6.75 |
| 24 months after baseline | 17.64 ± 7.42 | 13.13 ± 7.19 |
| 36 months after baseline | 15.00 ± 7.01 | 14.08 ± 5.71 |
The Parent Motivation Inventory (PMI) is a self-report measure of parents' motivation to change parenting behaviors. The Readiness to Change subscale includes 14 items measuring parents' readiness to change their parenting behaviors. Subscale scores can range from 14 to 70 with higher scores indicated higher readiness to change.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 47.39 ± 12.24 | 52.09 ± 10.77 |
| 12 months after baseline | 40.22 ± 12.27 | 46.09 ± 12.70 |
| 24 months after baseline | 37.21 ± 15.02 | 39.63 ± 13.88 |
| 36 months after baseline | 33.46 ± 12.33 | 36.54 ± 11.83 |
The Parent Motivation Inventory (PMI) is a self-report measure of parents' motivation to change parenting behaviors. The Perceived Ability to Change subscale includes 4 items measuring parents' perceived ability to change their parenting behaviors. Subscale scores can range from 4 to 20 with higher scores indicated higher perceived ability to change.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 13.10 ± 3.80 | 13.70 ± 3.03 |
| 12 months after baseline | 11.70 ± 3.55 | 12.75 ± 3.50 |
| 24 months after baseline | 11.50 ± 4.88 | 10.44 ± 3.74 |
| 36 months after baseline | 10.69 ± 3.28 | 10.54 ± 4.07 |
The Hearing Aid Adherence Questionnaire is a parent-report measure assessing their child's use of their hearing aids. This measure includes a list of 9 situations (e.g., riding in a car, being at someone else's house) for which parents rate the frequency of their child's hearing aid use on a Likert-type scale from 1 (never) to 5 (always). The scale score is the mean of the parent's responses to each item. Scores can range from 1-5 and higher scores indicate more hearing aid use in more situations.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 4.47 ± 0.87 | 4.36 ± 0.89 |
| 12 months after baseline | 4.53 ± 0.83 | 4.42 ± 0.84 |
| 24 months after baseline | 3.92 ± 1.71 | 3.87 ± 1.42 |
| 36 months after baseline | 4.24 ± 1.48 | 3.79 ± 1.49 |
The Therapy Attitude Inventory is a parent-report measure evaluating parent satisfaction with therapy (developed for use with Parent-Child Interaction Therapy; in this study used to assess satisfaction with the adapted Behavioral Parent Training intervention). Parents rate their agreement with 10 items using a Likert-type scale (1-5) for each item. Scores can range from 10 to 50 with higher scores indicating more satisfaction.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| 6 months after baseline | 36.63 ± 6.49 | — |
| 18 months after baseline | 39.97 ± 5.99 | — |
| 30 months after baseline | 40.70 ± 5.62 | — |
The MacArthur Bates Communicative Development Inventories - Words \& Sentences - Words Produced section assesses the number of words currently spontaneously used by a child via parent-report. Raw scores can range from 0-680 with higher scores indicating more words produced by a child.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 568.18 ± 184.12 | 540.36 ± 214.70 |
| 12 months after baseline | 643.85 ± 98.08 | 593.35 ± 180.75 |
| 24 months after baseline | 661.00 ± 48.32 | 635.73 ± 162.65 |
| 36 months after baseline | 672.10 ± 24.29 | 678.25 ± 4.35 |
The MacArthur Bates Communicative Development Inventories - Words \& Sentences - Sentence Complexity Score assesses grammatical development by having parents review 37 pairs of sentences. For each pair, the parent selects the sentence that sounds more like their child's speech. One point is added for each selection of the more complex sentence in a pair. Sentence Complexity Scores can range from 0-37 with higher scores indicating higher levels of grammatical development.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 24.06 ± 12.09 | 22.98 ± 14.43 |
| 12 months after baseline | 29.70 ± 9.48 | 28.75 ± 11.75 |
| 24 months after baseline | 32.15 ± 6.89 | 32.33 ± 9.51 |
| 36 months after baseline | 33.80 ± 6.37 | 34.92 ± 3.37 |
The Peabody Picture Vocabulary Test (PPVT) Standard Score is a measure of a child's receptive language. The PPVT assesses receptive vocabulary by requiring children to identify one of four pictures corresponding to a spoken word. Administration follows standardized basal and ceiling procedures. Standard scores are derived with the standard score metric (M = 100, SD = 15) and higher scores indicate higher levels of receptive vocabulary.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 92.03 ± 15.51 | 91.32 ± 15.47 |
| 12 months after baseline | 90.80 ± 19.57 | 92.62 ± 21.67 |
| 24 months after baseline | 87.31 ± 17.74 | 88.27 ± 23.39 |
| 36 months after baseline | 87.40 ± 18.18 | 96.60 ± 18.34 |
The Clinical Evaluation of Language Fundamentals - Core Language Score (CELF-CLS) assesses language ability. The CELF is an individually administered standardized language assessment that assesses performance across multiple expressive and receptive language subtests. Age-appropriate versions of the CELF were administered (i.e., the CELF-Preschool-3 for children ages 3 and 4 years; the CELF-5 for children ages 5 years and up). On both versions of the CELF, the CLS is a composite score derived from subsets of language subtests appropriate for the child's age, estimating overall language ability by combining receptive and expressive language skills. The CLS standard score has a mean of 100 and standard deviation of 15. Interpretation of CLS standard scores: 130 or higher = very superior; 120-129 = superior; 110-119 = high average; 90-109 = average; 80-89 = low average; 70-79 = moderately low; less than 70 = very low. Higher scores indicate higher levels of language ability.
| standard score | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 89.06 ± 18.61 | 96.14 ± 16.35 |
| 12 months after baseline | 88.10 ± 18.51 | 93.21 ± 19.88 |
| 24 months after baseline | 82.25 ± 14.60 | 91.46 ± 21.05 |
| 36 months after baseline | 83.00 ± 16.64 | 93.20 ± 19.15 |
The Beginner's Intelligibility Test (BIT) assesses the intelligibility of 10 sentences repeated by a child in response to the test administrator speaking the sentence and showing a picture illustrating the sentence. The child's spoken sentences are audiorecorded and played for 3 naive listeners who write down what they heard. The BIT score is calculated as the mean percentage of opportunity words (the original words spoken by the test administrator) identified across the 3 listeners. Scores can range from 0 to 100.
| percentage of opportunity words | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 50.97 ± 33.71 | 62.08 ± 29.10 |
| 12 months after baseline | 62.42 ± 24.76 | 71.06 ± 25.52 |
| 24 months after baseline | 80.07 ± 25.87 | 75.86 ± 18.08 |
| 36 months after baseline | 83.14 ± 18.62 | 90.32 ± 7.09 |
The Meaningful Auditory Integration Scale - Bonding/Attachment to Hearing Device domain of the MAIS assesses to what degree a child seeks out or depends on their hearing device. Two interview questions are asked of the parent (one about child wearing the device, one about child's response when the device is non-functional) and parent responses are coded from 0 (Never) to 4 (Always). The sum of the coded responses is the score, which can range from 0-8, with higher scores indicating better bonding/attachment to the hearing device.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 5.41 ± 1.77 | 5.11 ± 2.16 |
| 12 months after baseline | 5.93 ± 1.70 | 5.46 ± 1.90 |
| 24 months after baseline | 4.83 ± 1.95 | 5.38 ± 2.55 |
| 36 months after baseline | 5.27 ± 2.24 | 6.09 ± 2.34 |
The Clinical Evaluation of Language Fundamentals - Expressive Language Index (CELF-ELI) assesses expressive language. The CELF is an individually administered standardized language assessment that assesses performance across multiple expressive and receptive language subtests. Age-appropriate versions of the CELF were administered (i.e., the CELF-Preschool-3 for children ages 3 and 4 years; the CELF-5 for children ages 5 years and up). On both versions of the CELF, the ELI is a composite score derived from subsets of expressive language subtests appropriate for the child's age. The ELI standard score has a mean of 100 and standard deviation of 15. Interpretation of ELI standard scores: 130 or higher = very superior; 120-129 = superior; 110-119 = high average; 90-109 = average; 80-89 = low average; 70-79 = moderately low; less than 70 = very low. Higher scores indicate higher levels of expressive language ability.
| standard score | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 87.49 ± 19.90 | 93.57 ± 16.43 |
| 12 months after baseline | 86.37 ± 20.28 | 91.27 ± 19.99 |
| 24 months after baseline | 80.75 ± 12.86 | 87.92 ± 20.57 |
| 36 months after baseline | 78.75 ± 16.93 | 93.10 ± 20.87 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Responsiveness score reflects parents' responsiveness (verbal or behavioral) to their child's questions, comments, and behaviors in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of parent responsiveness.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 5.95 ± 0.90 | 6.01 ± 0.93 |
| 6 months after baseline | 6.32 ± 0.70 | 6.10 ± 1.07 |
| 12 months after baseline | 6.31 ± 0.95 | 6.17 ± 0.99 |
| 18 months after baseline | 6.25 ± 0.87 | 6.27 ± 0.65 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent On-Task score reflects parents' initiative and persistence in engaging with the assigned task while interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of parents' observed on-task behavior.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 6.01 ± 1.00 | 5.91 ± 1.17 |
| 6 months after baseline | 6.00 ± 1.19 | 5.83 ± 1.10 |
| 12 months after baseline | 5.39 ± 1.33 | 5.93 ± 0.83 |
| 18 months after baseline | 5.75 ± 1.22 | 5.55 ± 1.04 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Verbalizations score reflects parents' amount of verbalizations in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of parent verbalizations.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 5.21 ± 0.69 | 5.08 ± 0.79 |
| 6 months after baseline | 5.17 ± 0.70 | 5.05 ± 0.77 |
| 12 months after baseline | 4.89 ± 0.82 | 5.17 ± 0.75 |
| 18 months after baseline | 5.25 ± 0.62 | 5.27 ± 0.79 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Responsiveness score reflects children's responsiveness (verbal or behavioral) to their parent's questions, comments, and behaviors in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child responsiveness.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 5.32 ± 1.11 | 5.35 ± 1.03 |
| 6 months after baseline | 5.46 ± 1.26 | 5.67 ± 1.06 |
| 12 months after baseline | 5.62 ± 1.45 | 5.93 ± 1.03 |
| 18 months after baseline | 5.50 ± 1.24 | 5.91 ± 0.94 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Autonomy score reflects children's autonomy/independence (e.g., leads and controls task - but does not include off-task behaviors) in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child autonomy.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 3.87 ± 1.44 | 4.09 ± 1.70 |
| 6 months after baseline | 3.90 ± 1.51 | 4.08 ± 1.82 |
| 12 months after baseline | 4.08 ± 1.93 | 4.30 ± 1.51 |
| 18 months after baseline | 3.50 ± 1.62 | 3.46 ± 1.13 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Activity score reflects children's level of physical movements (e.g., moving arms, jumping up and down) in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child activity.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 5.10 ± 0.90 | 5.18 ± 0.79 |
| 6 months after baseline | 4.92 ± 0.91 | 5.03 ± 1.05 |
| 12 months after baseline | 4.54 ± 0.99 | 5.18 ± 1.17 |
| 18 months after baseline | 4.67 ± 1.50 | 4.73 ± 1.10 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Verbalizations score reflects children's amount of verbalizations in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child verbalizations.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 4.07 ± 1.06 | 4.10 ± 1.06 |
| 6 months after baseline | 4.38 ± 0.94 | 4.23 ± 1.05 |
| 12 months after baseline | 4.09 ± 1.04 | 5.07 ± 0.96 |
| 18 months after baseline | 4.58 ± 1.17 | 4.90 ± 0.99 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Reciprocity score reflects parent-child dyads' level of reciprocity (e.g., shared positive affect, eye contact, turn-taking quality) in interacting with each other. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of reciprocity.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 4.92 ± 1.37 | 5.27 ± 1.31 |
| 6 months after baseline | 5.55 ± 1.30 | 5.22 ± 1.30 |
| 12 months after baseline | 5.46 ± 1.81 | 5.13 ± 1.46 |
| 18 months after baseline | 5.92 ± 1.00 | 5.33 ± 1.12 |
The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Cooperation score reflects parent-child dyads' level of explicit agreement/discussion of how to complete the task together (e.g., "Shall we do this next?" "Yes") in interacting with each other. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of cooperation.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Baseline | 3.96 ± 1.55 | 3.68 ± 1.82 |
| 6 months after baseline | 3.56 ± 1.92 | 3.61 ± 1.77 |
| 12 months after baseline | 2.68 ± 1.71 | 3.23 ± 1.52 |
| 18 months after baseline | 3.75 ± 1.66 | 4.22 ± 1.20 |
The Therapeutic Alliance Scale for Caregivers and Parents measures self-reported strength of perceived therapeutic alliance with their interventionist. Parents rate their level of agreement with 12 statements describing aspects of the therapeutic alliance using Likert-type scales from 1 (Not true) to 4 (Very true). The TASCP score is the mean of these responses with possible scores ranging from 1 to 4. Higher scores indicate stronger perceived therapeutic alliance with the interventionist. This measure was added to the study to capture an aspect of satisfaction not included in the Therapy Attitude Inventory.
| score on a scale | Behavioral Parent Training | Control |
|---|---|---|
| Therapeutic Alliance Scale for Caregivers and Parents (TASCP) | 3.36 ± 0.67 | — |
Several aspects of satisfaction with the intervention and interventionist were not captured in originally planned measures. The investigators created 7 items for parents to rate their level of agreement with using Likert-type scales from 1 (Not true) to 4 (Very true). These items are not intended to be a scale but to provide information about specific aspects of satisfaction and experience. The score for each item can range from 1-4. Higher scores indicate higher levels of agreement with each individual statement. These items were added to the study to capture aspects of satisfaction not included in the Therapy Attitude Inventory.
| units on a scale | Behavioral Parent Training | Control |
|---|---|---|
| I think my parent coach has the training and experience needed to help me with parenting skills. | 3.35 ± 0.92 | — |
| My parent coach explained the purpose of these sessions in a way that made sense to me. | 3.44 ± 0.89 | — |
| It was important to me that my parent coach is also the parent of child who's deaf/hard of hearing. | 3.49 ± 0.91 | — |
| I could rely on my parent coach to be timely in communicating with me (scheduling, responding, etc.) | 3.50 ± 0.92 | — |
| It felt difficult to find the time for these sessions with everything else going on in my life. | 2.70 ± 1.13 | — |
| My parent coach offered me appointment times that were convenient for me. | 3.54 ± 0.83 | — |
| Technology challenges made the parent coaching sessions difficult. | 1.33 ± 0.61 | — |
Collected over 36 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Behavioral Parent Training | 0/71 (0%) | 0/71 (0%) | 5/71 (7%) |
| Control | 0/54 (0%) | 0/54 (0%) | 3/54 (5.6%) |
| Event | Behavioral Parent Training | Control |
|---|---|---|
| Suicidal IdeationPsychiatric disorders | 5/71 | 3/54 |
Aim 2 participants were not enrolled in Aim 4 or Aim 5; there is no overlap in participants across Aim 2 and Aim 4 and across Aim 2 and Aim 5. Aim 5 demographics are reported for (n=10) interventionists. Aim 5 demographics do not include: 1) stakeholders (n = 10) because they haven't been enrolled yet and 2) parents (n = 18) because they were also enrolled in Aim 4 and those demographics are reported under Aim 4.
| Age, Continuous(years) | Aim 2 Interviews and Focus Groups for Intervention Adaptation | Aim 4 Behavioral Parent Training | Aim 4 Control | Aim 5 Implementation Data | Total |
|---|---|---|---|---|---|
| Parents | 34.55 ± 5.98 | 35.18 ± 5.71 | 35.83 ± 5.45 | — | 35.33 ± 5.63 |
| Children | — | 4.99 ± 1.24 | 5.02 ± 1.14 | — | 5.01 ± 1.19 |
| Interventionists | — | — | — | 43.20 ± 12.02 | 43.20 ± 12.02 |
| Sex: Female, Male(Participants) | Aim 2 Interviews and Focus Groups for Intervention Adaptation | Aim 4 Behavioral Parent Training | Aim 4 Control | Aim 5 Implementation Data | Total |
|---|---|---|---|---|---|
| Parents — Female | 19 | 70 | 52 | — | 141 |
| Parents — Male | 1 | 1 | 2 | — | 4 |
| Children — Female | — | 40 | 25 | — | 65 |
| Children — Male | — | 31 | 29 | — | 60 |
| Interventionists — Female | — | — | — | 10 | 10 |
| Interventionists — Male | — | — | — | 0 | 0 |
| Stakeholders — Female | 15 | — | — | — | 15 |
| Stakeholders — Male | 0 | — | — | — | 0 |
| Ethnicity (NIH/OMB)(Participants) | Aim 2 Interviews and Focus Groups for Intervention Adaptation | Aim 4 Behavioral Parent Training | Aim 4 Control | Aim 5 Implementation Data | Total |
|---|---|---|---|---|---|
| Parents — Hispanic or Latino | 0 | 4 | 3 | — | 7 |
| Parents — Not Hispanic or Latino | 20 | 67 | 51 | — | 138 |
| Parents — Unknown or Not Reported | 0 | 0 | 0 | — | 0 |
| Children — Hispanic or Latino | — | 5 | 4 | — | 9 |
| Children — Not Hispanic or Latino | — | 65 | 50 | — | 115 |
| Children — Unknown or Not Reported | — | 1 | 0 | — | 1 |
| Interventionists — Hispanic or Latino | — | — | — | 0 | 0 |
| Interventionists — Not Hispanic or Latino | — | — | — | 10 | 10 |
| Interventionists — Unknown or Not Reported | — | — | — | 0 | 0 |
| Stakeholders — Hispanic or Latino | 0 | — | — | — | 0 |
| Stakeholders — Not Hispanic or Latino | 15 | — | — | — | 15 |
| Stakeholders — Unknown or Not Reported | 0 | — | — | — | 0 |
| Race (NIH/OMB)(Participants) | Aim 2 Interviews and Focus Groups for Intervention Adaptation | Aim 4 Behavioral Parent Training | Aim 4 Control | Aim 5 Implementation Data | Total |
|---|---|---|---|---|---|
| Parents — American Indian or Alaska Native | 0 | 0 | 0 | — | 0 |
| Parents — Asian | 0 | 0 | 2 | — | 2 |
| Parents — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | — | 0 |
| Parents — Black or African American | 2 | 4 | 4 | — | 10 |
| Parents — White | 17 | 63 | 46 | — | 126 |
| Parents — More than one race | 1 | 4 | 2 | — | 7 |
| Parents — Unknown or Not Reported | 0 | 0 | 0 | — | 0 |
| Children — American Indian or Alaska Native | — | 1 | 0 | — | 1 |
| Children — Asian | — | 0 | 1 | — | 1 |
| Children — Native Hawaiian or Other Pacific Islander | — | 0 | 0 | — | 0 |
| Children — Black or African American | — | 3 | 4 | — | 7 |
| Children — White | — | 56 | 43 | — | 99 |
| Children — More than one race | — | 8 | 6 | — | 14 |
| Children — Unknown or Not Reported | — | 3 | 0 | — | 3 |
| Interventionists — American Indian or Alaska Native | — | — | — | 0 | 0 |
| Interventionists — Asian | — | — | — | 0 | 0 |
| Interventionists — Native Hawaiian or Other Pacific Islander | — | — | — | 0 | 0 |
| Interventionists — Black or African American | — | — | — | 0 | 0 |
| Interventionists — White | — | — | — | 10 | 10 |
| Interventionists — More than one race | — | — | — | 0 | 0 |
| Interventionists — Unknown or Not Reported | — | — | — | 0 | 0 |
| Stakeholders — American Indian or Alaska Native | 0 | — | — | — | 0 |
| Stakeholders — Asian | 0 | — | — | — | 0 |
| Stakeholders — Native Hawaiian or Other Pacific Islander | 0 | — | — | — | 0 |
| Stakeholders — Black or African American | 0 | — | — | — | 0 |
| Stakeholders — White | 15 | — | — | — | 15 |
| Stakeholders — More than one race | 0 | — | — | — | 0 |
| Stakeholders — Unknown or Not Reported | 0 | — | — | — | 0 |
| Region of Enrollment(participants) | Aim 2 Interviews and Focus Groups for Intervention Adaptation | Aim 4 Behavioral Parent Training | Aim 4 Control | Aim 5 Implementation Data | Total |
|---|---|---|---|---|---|
| United States | 35 | 142 | 108 | 10 | 295 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
Access criteria: De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
Ran from Jun 2021 to primary completion in Oct 2024, 39 months.
Results were first posted in Mar 2026, 1 year 5 months after primary completion.
Of 50 non-industry interventional studies with no phase under Deafness, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 20. This study's 39 months is below that.
Counting every sponsor, half of 58 studies reached it within 31 months; a quarter within 17.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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