An interventional study of Clinical Assessment and CFI and Clinical Assessment in Disruptive Behavior, sponsored by Florida International University. Completed at 1 site in United States. Open to participants aged 2 Years to 7 Years. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by Florida International University · Not applicable, Interventional, and Other
The project at the center of this proposal will leverage a pilot randomized design to examine initial feasibility and preliminary effects of augmenting usual mental health evaluation procedures with a structured person-centered assessment tool that specifically considers the cultural context of patient mental health problems (i.e., the Cultural Formulation Interview; CFI) on parent satisfaction, engagement and clinical child outcomes in the treatment of early child behavior problems. Additional analyses will explore whether traditional barriers (e.g., stigma, ethnic identity, and daily stress) moderate the effects of the CFI on satisfaction, engagement and treatment outcomes.
This project is leveraging a pilot randomized design to evaluate initial feasibility and preliminarily examine whether augmenting assessment procedures for child behavior problems with the CFI improves satisfaction with assessment procedures and treatment, parent engagement in subsequent behavior parent training, and ultimately clinical child outcomes. Exploratory analyses will further consider whether traditional barriers to care moderate outcomes. The study is being conducted within a large South Florida mental health network serving predominately low-income minority families obtaining parent training for early child behavior problems. Participating families will be randomized at baseline to receive either the standard diagnostic and clinical assessment (CA) or CA+CFI.
Specifically, the investigators are interested in assessing study feasibility. Feasibility of recruitment and randomization, study retention, and condition integrity will be monitored. Additionally, clinician reports of CFI feasibility, acceptability and clinical utility will be examined. An additional main outcome will be initial satisfaction directly after the interview. It is hypothesized that families in the CA+CFI group will report higher levels of initial satisfaction than the CA group. A secondary goal is to assess preliminary effects of administering the CFI on treatment satisfaction, engagement and clinical child outcomes. Parents and therapists will report on their satisfaction with treatment. Engagement outcomes will be measured via: (a) initial session attendance, (b) drop out rate (c) session attendance rate, (d) homework completion rate, and (e) therapeutic alliance. Clinical outcomes will be measured via parent ratings of child behavior problems and parent time to skill mastery. It is hypothesized that CA+CFI families will demonstrate improved satisfaction, engagement and clinical outcomes relative to CA families. Further exploratory analyses will examine individual differences in effects related to traditional barriers to care. Exploratory analyses will examine stigma, ethnic identity, and daily stress as moderators of the effects of CFI administration on satisfaction, engagement and clinical outcomes. It is hypothesized that CFI effects will be particularly strong for families who experience greater traditional barriers to care.
Exclusion Criteria:
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Behavioral: Clinical Assessment and CFI
CA families will receive a standard Clinical Assessment during intake.
Behavioral: Clinical Assessment
CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
CA families will participate their standard intake procedures.
CFI Clinician Questionnaire
The CFI Clinician Questionnaire is a 4-item measure developed designed to assess clinical utility of the CFI. Items are rated on a 5-point Likert style scale ranging from 1='not at all' to 5='very much'. Each item has a minimum score of 1 and a max of 5. Items include the extent to which conducting the CFI influences content and quality of information obtained in the intake, realtionship with the caregiver, treatment planning, and differential diagnosis. Higher scores indicate higher levels of clinical utility of the CFI. The measure was given only to the CA + CFI condition. This analysis was utilized to assess for initial utility of the CFI and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were descriptive and only examined for the experimental group.
Time frame: Post Intake Assessment (Week 0)
Satisfaction With Intake Questionnaire
The Satisfaction with Intake Questionnaire is a 7-item measure developed for use in the current study to assess parent and clinician satisfaction with their intake assessment. This measure assesses how well the patient/clinician felt the clinician understood the family's problems, cultural background, how their culture may influence their problem, and how much the parent trusts the clinician. Items are rated on a 5-point Likert style scale ranging from 1='not at all' to 5='very much', with higher scores representing higher satisfaction. Each item has a minimum of 1 and maximum of 5. Items were not summed. Two items were analyzed separately for the main outcomes: linear regressions tested condition effects on caregiver and provider satisfaction, and the extent to which the provider understood the caregivers' values or what is important to them.
Time frame: Post Intake Assessment (Week 0)
CFI Fidelity Instrument
The CFI Fidelity Instrument assesses fidelity to the CFI (i.e. adherence and competence) in the CA+CFI group and potential cross-condition contamination in CA condition. Independent evaluators masked to condition, study design, and study hypotheses coded recordings of all assessments. This analysis was utilized to assess for feasibility of the pilot study and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were only descriptive.
Time frame: Post Intake Assessment (Week 0)
Working Alliance Inventory-Short Form Revised
The WAI-Short Form Revised (WAI-SR; Hatcher \& Gillaspy, 2006) is a 12-item clinician- and patient-report measure of therapeutic alliance that assesses (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Items are rated on a 5-point Likert style scale ranging from 1='never' to 5='always'. Scores on each sub scale are summed to create a total score. Total scores range from 12-60 with higher scores representing higher therapeutic alliance.
Time frame: Post Treatment (Anticipated average: Week 14)
Treatment Response
Treatment response reflected traditional PCIT graduation criteria: caregiver skill acquisition as coded against specific criteria in both phases of treatment; and (b) child behavior problems dropped into the subclinical range. Families were classified as Treatment Responders in accordance with formal PCIT graduation criteria, that is: (a) caregivers demonstrated skill acquisition, as coded against specific criteria in both phases of treatment; and (b) child behavior problems dropped into the subclinical range - i.e., Eyberg Child Behavior Inventory (ECBI) falls below 114). Participants were coded as either treatment responders=1, or treatment non-responders=0.
Time frame: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)
Engagement
Engagement will be measured for each family via: (a) dichotomous coding of initial session attendance (yes=1, no=0), (b) dichotomous coding of whether they completed the first treatment module (yes=1, no=0), (c) attendance rate (number of sessions attended over number of weeks in treatment), and (d) mean weekly homework completion across treatment (Homework Compliance)
Time frame: Change from Baseline (Week 0) through post treatment
Therapy Attitudes Inventory
The Therapy Attitudes Inventory (TAI; Brestan et al., 2000) is a 10-item parent-report of satisfaction with treatment including change in child behavior problems and parenting skills on a likert style scale from 1="nothing"-5="very many useful techniques". Items are summed to create a total score. Minimum value is 10 and maximum value is 50. Higher scores represent higher satisfaction with treatment.
Time frame: Post Treatment (anticipated average: Week 14)
Eyberg Child Behavior Inventory
The Eyberg Child Behavior Inventory (ECBI; Eyberg \& Pincus, 1999) is a 36-item parent-report measure of disruptive behavior problems in children as young as 2 years that has shown strong psychometrics. The intensity score is summed to form a total score and ranges from 36 to 252 with higher numbers representing more severe behavior problems. The difference in ECBI score between baseline and treatment completion was measured.
Time frame: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)
Everyday Stressors Index
The Everyday Stressors Index (ESI Hall, 1983) is a 20-item measure that assesses daily stressors experienced by economically disadvantaged parents with young children. Items are rated on a Likert-style scale ranging from 1='not at bothered' to 4='bothered a great deal' with higher scores indicating higher levels of stress. The minimum value=20, and maximum value=80 This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Time frame: Post Intake Assessment (Week 0)
Multigroup Ethnic Identity Measure- Revised
The Multigroup Ethnic Identity Measure- Revised (MEIM-R; Phinney \& Ong, 2007) is a 6-item measure that assesses exploration of and commitment to one's ethnic group. Items are rated on a 5-point Likert-style scale from 1='strongly disagree' to 6='strongly agree', with higher scores indicating stronger ethnic identity. This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Time frame: Post Intake Assessment (Week 0)
Parental Attitudes Toward Psychological Services Inventory
Two subscales of the Parental Attitudes Toward Psychological Services Inventory (PATPSI; Turner, 2012) will be administered: help seeking attitudes scale (8 items) and the stigmatization scale (8 items) comprising 16 items total. The PATPSI assesses caregivers' attitudes toward outpatient mental health services. Items are rated on a 5-point Likert-style scale from 0='strongly disagree' to 5='strongly agree'. Item responses are summed to form a stigma total scale (minimum value=0 and maximum value=40) and a help seeking total scale (minimum value=0 and maximum value=40) with higher scores representing more mental health related stigma and more positive attitudes toward mental health services. This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Time frame: Post Intake Assessment (Week 0)
Everyday Discrimination Scale
The Everyday Discrimination Scale (EDS; Williams et al., 1997) is a 9-item measure that assesses aspects of interpersonal discrimination or unfair treatment in their day-to-day life. Items are rated on a Likert-style scale ranging from 0='never' to 5='almost every day', with higher scores indicating more experiences of discrimination. The minimum score is 0 and maximum score is 45. Scores were averaged to create a mean discrimination score which could range from 0 to 5. This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Time frame: Post Intake Assessment (Week 0)
Families were recruited and randomized from August 2017 to October 2018; data collection continued through May 2019. Recruitment and data collection during the provision of clinical services within three community clinics that were embedded within neighborhood centers regularly accessed by the community (i.e., afterschool care centers, family and neighborhood resource programs).
| Milestone | Clinical Assessment and CFI | Clinical Assessment Only |
|---|---|---|
| Started | 39 | 50 |
| Completed | 18 | 20 |
| Not completed | 21 | 30 |
| Withdrew: Caregiver/child dyad dropped out before completing a full course of treatment | 21 | 30 |
The CFI Clinician Questionnaire is a 4-item measure developed designed to assess clinical utility of the CFI. Items are rated on a 5-point Likert style scale ranging from 1='not at all' to 5='very much'. Each item has a minimum score of 1 and a max of 5. Items include the extent to which conducting the CFI influences content and quality of information obtained in the intake, realtionship with the caregiver, treatment planning, and differential diagnosis. Higher scores indicate higher levels of clinical utility of the CFI. The measure was given only to the CA + CFI condition. This analysis was utilized to assess for initial utility of the CFI and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were descriptive and only examined for the experimental group.
| units on a scale | Clinical Assessment and CFI |
|---|---|
| Quality of Information Received | 4.2 ± .59 |
| Relationship with Caregiver | 4.1 ± .92 |
| Treatment Planning | 3.8 ± .89 |
| Differential Diagnosis | 3.6 ± 1 |
The Satisfaction with Intake Questionnaire is a 7-item measure developed for use in the current study to assess parent and clinician satisfaction with their intake assessment. This measure assesses how well the patient/clinician felt the clinician understood the family's problems, cultural background, how their culture may influence their problem, and how much the parent trusts the clinician. Items are rated on a 5-point Likert style scale ranging from 1='not at all' to 5='very much', with higher scores representing higher satisfaction. Each item has a minimum of 1 and maximum of 5. Items were not summed. Two items were analyzed separately for the main outcomes: linear regressions tested condition effects on caregiver and provider satisfaction, and the extent to which the provider understood the caregivers' values or what is important to them.
| units on a scale | Clinical Assessment and CFI | Clinical Assessment Only |
|---|---|---|
| Caregiver Post-Assessment Perceptions and Satisfaction: Provider understands family values | 4.48 ± .93 | 4.32 ± .88 |
| Caregiver Post-Assessment Perceptions and Satisfaction: Overall Satisfaction | 4.61 ± .93 | 4.7 ± .75 |
| Provider Post-Assessment Perceptions and Satisfaction: Understands family values | 4.57 ± .99 | 4.12 ± .73 |
| Provider Post-Assessment Perceptions and Satisfaction: Overall Satisfaction | 4.66 ± .7 | 4.52 ± .71 |
The CFI Fidelity Instrument assesses fidelity to the CFI (i.e. adherence and competence) in the CA+CFI group and potential cross-condition contamination in CA condition. Independent evaluators masked to condition, study design, and study hypotheses coded recordings of all assessments. This analysis was utilized to assess for feasibility of the pilot study and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were only descriptive.
| percentage of adherence to CFI | Clinical Assessment and CFI | Clinical Assessment Only |
|---|---|---|
| CFI Fidelity Instrument | 84.4 ± 21.5 | 4.8 ± 10.5 |
The WAI-Short Form Revised (WAI-SR; Hatcher \& Gillaspy, 2006) is a 12-item clinician- and patient-report measure of therapeutic alliance that assesses (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Items are rated on a 5-point Likert style scale ranging from 1='never' to 5='always'. Scores on each sub scale are summed to create a total score. Total scores range from 12-60 with higher scores representing higher therapeutic alliance.
| score on a scale | Clinical Assessment and CFI | Clinical Assessment Only |
|---|---|---|
| Working Alliance Inventory-Short Form Revised | 54.03 ± 8.9 | 57.06 ± 7.21 |
Treatment response reflected traditional PCIT graduation criteria: caregiver skill acquisition as coded against specific criteria in both phases of treatment; and (b) child behavior problems dropped into the subclinical range. Families were classified as Treatment Responders in accordance with formal PCIT graduation criteria, that is: (a) caregivers demonstrated skill acquisition, as coded against specific criteria in both phases of treatment; and (b) child behavior problems dropped into the subclinical range - i.e., Eyberg Child Behavior Inventory (ECBI) falls below 114). Participants were coded as either treatment responders=1, or treatment non-responders=0.
| probability treatment response | Clinical Assessment and CFI | Clinical Assessment Only |
|---|---|---|
| Treatment Response | .53 | .35 |
Engagement will be measured for each family via: (a) dichotomous coding of initial session attendance (yes=1, no=0), (b) dichotomous coding of whether they completed the first treatment module (yes=1, no=0), (c) attendance rate (number of sessions attended over number of weeks in treatment), and (d) mean weekly homework completion across treatment (Homework Compliance)
| probability of engagement | Clinical Assessment and CFI | Clinical Assessment Only |
|---|---|---|
| Session Attendance | .65 | .57 |
| Homework Completion | .49 | .46 |
| Initial Session Attendance | .95 | .91 |
| Completion of first treatment modules | .75 | .35 |
The Therapy Attitudes Inventory (TAI; Brestan et al., 2000) is a 10-item parent-report of satisfaction with treatment including change in child behavior problems and parenting skills on a likert style scale from 1="nothing"-5="very many useful techniques". Items are summed to create a total score. Minimum value is 10 and maximum value is 50. Higher scores represent higher satisfaction with treatment.
| score on a scale | Clinical Assessment and CFI | Clinical Assessment Only |
|---|---|---|
| Therapy Attitudes Inventory | 48.490 ± 3.63 | 48.581 ± 2.58 |
The Eyberg Child Behavior Inventory (ECBI; Eyberg \& Pincus, 1999) is a 36-item parent-report measure of disruptive behavior problems in children as young as 2 years that has shown strong psychometrics. The intensity score is summed to form a total score and ranges from 36 to 252 with higher numbers representing more severe behavior problems. The difference in ECBI score between baseline and treatment completion was measured.
| units on a scale | Clinical Assessment and CFI | Clinical Assessment Only |
|---|---|---|
| Eyberg Child Behavior Inventory | 46.35 ± 42.67 | 51.737 ± 39.47 |
The Everyday Stressors Index (ESI Hall, 1983) is a 20-item measure that assesses daily stressors experienced by economically disadvantaged parents with young children. Items are rated on a Likert-style scale ranging from 1='not at bothered' to 4='bothered a great deal' with higher scores indicating higher levels of stress. The minimum value=20, and maximum value=80 This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
| score on a scale | Clinical Assessment and CFI | Clinical Assessment Only |
|---|---|---|
| Everyday Stressors Index | 32.6 ± 6.9 | 34.7 ± 9.3 |
The Multigroup Ethnic Identity Measure- Revised (MEIM-R; Phinney \& Ong, 2007) is a 6-item measure that assesses exploration of and commitment to one's ethnic group. Items are rated on a 5-point Likert-style scale from 1='strongly disagree' to 6='strongly agree', with higher scores indicating stronger ethnic identity. This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
| score on a scale | Clinical Assessment and CFI | Clinical Assessment Only |
|---|---|---|
| Multigroup Ethnic Identity Measure- Revised | 2.729 ± 1.667 | 2.778 ± .838 |
Two subscales of the Parental Attitudes Toward Psychological Services Inventory (PATPSI; Turner, 2012) will be administered: help seeking attitudes scale (8 items) and the stigmatization scale (8 items) comprising 16 items total. The PATPSI assesses caregivers' attitudes toward outpatient mental health services. Items are rated on a 5-point Likert-style scale from 0='strongly disagree' to 5='strongly agree'. Item responses are summed to form a stigma total scale (minimum value=0 and maximum value=40) and a help seeking total scale (minimum value=0 and maximum value=40) with higher scores representing more mental health related stigma and more positive attitudes toward mental health services. This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
| score on a scale | Clinical Assessment and CFI | Clinical Assessment Only |
|---|---|---|
| Stigma Subscale | 5.847 ± 5.19 | 6.172 ± 5.57 |
| Help Seeking Subscale | 6.384 ± 5.718 | 6.970 ± 6.097 |
The Everyday Discrimination Scale (EDS; Williams et al., 1997) is a 9-item measure that assesses aspects of interpersonal discrimination or unfair treatment in their day-to-day life. Items are rated on a Likert-style scale ranging from 0='never' to 5='almost every day', with higher scores indicating more experiences of discrimination. The minimum score is 0 and maximum score is 45. Scores were averaged to create a mean discrimination score which could range from 0 to 5. This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
| score on a scale | Clinical Assessment and CFI | Clinical Assessment Only |
|---|---|---|
| Everyday Discrimination Scale | .806 ± .746 | .658 ± .627 |
Collected over Approximately 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clinical Assessment and CFI | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Clinical Assessment Only | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
CA + CFI group = 39 caregivers and 39 children (39 caregiver/child dyads). CA only group = 50 caregivers and 50 children (50 caregiver/child dyads)
| Age, Continuous(years) | Clinical Assessment and CFI | Clinical Assessment Only | Total |
|---|---|---|---|
| Child Age | 5.2 ± 1.6 | 5.03 ± 1.5 | 5.1 ± 1.6 |
| Caregiver Age | 35.1 ± 7.4 | 33.8 ± 70 | 34.4 ± 7.2 |
| Sex: Female, Male(Participants) | Clinical Assessment and CFI | Clinical Assessment Only | Total |
|---|---|---|---|
| Child Sex — Female | 11 | 17 | 28 |
| Child Sex — Male | 28 | 33 | 61 |
| Race (NIH/OMB)(Participants) | Clinical Assessment and CFI | Clinical Assessment Only | Total |
|---|---|---|---|
| Child Race — American Indian or Alaska Native | 1 | 0 | 1 |
| Child Race — Asian | 1 | 0 | 1 |
| Child Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Child Race — Black or African American | 11 | 8 | 19 |
| Child Race — White | 22 | 34 | 56 |
| Child Race — More than one race | 4 | 4 | 8 |
| Child Race — Unknown or Not Reported | 0 | 4 | 4 |
| Primary Caregiver Race — American Indian or Alaska Native | 1 | 0 | 1 |
| Primary Caregiver Race — Asian | 1 | 0 | 1 |
| Primary Caregiver Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Primary Caregiver Race — Black or African American | 12 | 9 | 21 |
| Primary Caregiver Race — White | 22 | 34 | 56 |
| Primary Caregiver Race — More than one race | 3 | 2 | 5 |
| Primary Caregiver Race — Unknown or Not Reported | 0 | 5 | 5 |
| Race/Ethnicity, Customized(Participants) | Clinical Assessment and CFI | Clinical Assessment Only | Total |
|---|---|---|---|
| Child Ethnicity — Hispanic/Latinx | 21 | 35 | 56 |
| Child Ethnicity — Haitian | 1 | 3 | 4 |
| Child Ethnicity — Non-Hispanic or Haitian | 17 | 12 | 29 |
| Primary Caregiver Ethnicity — Hispanic/Latinx | 20 | 36 | 56 |
| Primary Caregiver Ethnicity — Haitian | 2 | 2 | 4 |
| Primary Caregiver Ethnicity — Non-Hispanic or Haitian | 17 | 12 | 29 |
| Income to needs ratio(ratio) | Clinical Assessment and CFI | Clinical Assessment Only | Total |
|---|---|---|---|
| Mean | 2.2 ± 2.8 | 2.6 ± 4.01 | 2.4 ± 3.5 |
| Caregiver Education(Participants) | Clinical Assessment and CFI | Clinical Assessment Only | Total |
|---|---|---|---|
| < High School | 4 | 10 | 14 |
| High School/GED | 12 | 15 | 27 |
| Some College/AA | 8 | 9 | 17 |
| Bachelor's Degree | 8 | 9 | 17 |
| Graduate Degree | 7 | 7 | 14 |
| Everyday Stressors Index(scores on a scale) | Clinical Assessment and CFI | Clinical Assessment Only | Total |
|---|---|---|---|
| Mean | 32.6 ± 6.9 | 34.7 ± 9.3 | 33.8 ± 8.4 |
| Eyberg Child Behavior Inventory(units on a scale) | Clinical Assessment and CFI | Clinical Assessment Only | Total |
|---|---|---|---|
| Mean | 157.1 ± 34.2 | 149.2 ± 27.2 | 152.9 ± 30.7 |
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Florida International University