An interventional study of Behavioral Parent Training (BPT) in ADHD, sponsored by NYU Langone Health. Completed at 3 sites in United States. Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
Access to evidence-based psychosocial interventions, particularly Behavioral Parent Training (BPT), for youth with Attention Deficit/Hyperactivity Disorder (ADHD) is limited. An approach to increasing such access is to utilize trained paraprofessionals (Family Peer Advocates; FPAs) in the delivery of BPT, particularly through modalities, like telehealth, that further improve access and availability. This approach, FPA-delivered BPT via telehealth has yet to be studied. This study will evaluate the benefits of a FPA-delivered BPT for parents of children identified with ADHD in Developmental Behavioral Pediatric (DBPs).
There are two aims of the study: Specific Aim 1: To determine the benefits of a FPA-delivered telehealth BPT model on children's ADHD symptoms, oppositional behavior, functional outcomes, parenting behavior and parental stress. Specific Aim 2: Understand the shared decision making process between the parent, physician, and FPA within the Pediatric- Family Peer Advocate (PEDS-FPA) model through qualitative interviews.
1,547 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.
This study's enrollment of 13 is below the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.
Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.
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Exclusion Criteria:
Behavioral: Behavioral Parent Training (BPT)
BPT is an evidence-based psychosocial intervention that is directed exclusively to parent of children with ADHD and related disorders. BPT focuses on instructing parents to use approaches to enhance the parent-child relationship (e.g., quality time, praise) and proactive discipline strategies (e.g., time out, reward systems) to reduce challenging child behavior.
Change in IOWA Connors Rating Scale (IOWA-CRS) Score
The IOWA-CRS is a widely used brief measure of attention-deficit/hyperactivity disorder and oppositional-defiant behavior in children completed by parents. IOWA-CRS consists of 10 items evaluated using a four-point Likert scale with the following anchors: not at all (0); just a little (1); pretty much (2); and very much (3). The total score range is 10-40; the higher the score, the more concerns with the child's behavior.
Time frame: Baseline, Week 11
Change in Impairment Rating Scale (IRS) Score
The IRS measures impairment across domains of functioning, as well as overall need for treatment - consists of 7 items. Parents report on a 7-point scale to signify their child's functioning along a continuum of impairment that ranges from 0 (Not a problem at all. Definitely does not need treatment or special services.) to 6 (Extreme problem. Definitely needs treatment and special services). The total score range is 0-42; the higher the score, the more extreme the challenges and higher the need for intervention.
Time frame: Baseline, Week 11
Change in Alabama Parenting Questionnaire- Short Form (APQ-9) Score
APQ-9 is a well-validated 9-item measure of parenting style. Items are rated by the parent scored based on frequency of parenting behavior from Never (1), Almost Never (2), Sometimes (3), Often (4), Always (5). APQ-SF items are based around the three main structures: positive parenting (items 1, 6-7), inconsistent discipline (items 2, 4, 9) and poor supervision (items 3, 5, 8). The score range per structure is 3-27; the higher the score, the more frequent the parenting behavior (e.g., higher scores in positive parenting structure indicates more frequent positive parenting).
Time frame: Baseline, Week 11
Change in Parental Stress - Short Form (PSI-SF) Total Stress Score
PSI-SF is a 36-item self-report measure used to assess parenting stress in three domains, Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The PSI-SF is measured along a 5-point scale with one (Strongly Disagree) to five (Strongly Agree). Higher scores indicate greater levels of parenting stress. For this study, the Total Stress score, which is the sum of the three PSI-SF domains, will be used (total score range = 36-180).
Time frame: Baseline, Week 11
Change in Barriers to Treatment Participation Scale (BTPS) Score
BTPS measures barriers to treatment participation involving stressors and obstacles that compete with treatment (e.g., conflict with significant other), treatment demands and issues (e.g., treatment was too confusing), and perceived relevance of treatment (treatment met parent's expectations). BTPS consists of 18 items and is measured along a 5-point scale with 1 (Never a problem) to 5 (Always a problem). The total score range is 18-90; the higher the score, the more barriers to treatment participant.
Time frame: Baseline, Week 11
Change in Therapy Attitude Inventory (TAI) Score
TAI is a valid index of consumer satisfaction for participants in BPT. Items are rated on a scale from one (indicating treatment dissatisfaction or lack of improvement) to five (indicating satisfaction with treatment and improvement). Parents will complete this form after the last session of the BPT program. BPT consists of 11 items that are scored on a 5-point Likert scale. The total score range is 11-55; the higher the score, the greater the satisfaction.
Time frame: Baseline, Week 11
Ran from Jul 2022 to primary completion in Sep 2023, 14 months.
Of 393 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's 14 months is below that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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