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OpenTrials
Completed

NCT Number: NCT05301933

Telehealth BPT in DBP Practice

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).

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health - NYC Health+Hospitals, Bellevue Hospital, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child must be between the ages of 4-11 years
  • Child must be diagnosed with ADHD (any subtype) within the last 6 months
  • Parent/ legal guardian must be at least 18 years old
  • Parent/ legal guardian must be legal guardian of child
  • Parent/ legal guardian must speak English or Spanish
  • Parent/ legal guardian must not have previously received manualized, multi-session behavioral parent training (BPT)
  • Child must be under public or no insurance
  • Parent/legal guardian must be able to provide consent.

Exclusion criteria

  • Children with ADHD who have significant mental health comorbidities that warrant more intensive psychosocial/pharmacological intervention per physician recommendations
  • Parent/ legal guardian who does not have access to reliable internet service to participate in telehealth delivered BPT
  • Parent/ legal guardian with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia, other significant mental illness)
  • Parent/ legal guardian who has limited, consistent contact with their child (i.e., less than 3 days/week)

Treatment and study plan

Behavioral Parent Training (BPT)

Behavioral

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.

Primary outcomes

  1. Change in IOWA Connors Rating Scale (IOWA-CRS) Score

    Time frame: Baseline, Week 11

    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.

  2. Change in Impairment Rating Scale (IRS) Score

    Time frame: Baseline, Week 11

    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.

  3. Change in Alabama Parenting Questionnaire- Short Form (APQ-9) Score

    Time frame: Baseline, Week 11

    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).

  4. Change in Parental Stress - Short Form (PSI-SF) Total Stress Score

    Time frame: Baseline, Week 11

    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).

  5. Change in Barriers to Treatment Participation Scale (BTPS) Score

    Time frame: Baseline, Week 11

    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.

  6. Change in Therapy Attitude Inventory (TAI) Score

    Time frame: Baseline, Week 11

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Pilot Proof of Concept, Multisite, Open Clinical Trial of Telehealth Behavioral Parent Training on Improving Access and Outcomes for Children With ADHD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2022
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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