Reducing Disparities in Behavioral Health Treatment for Children in Primary Care (PASS)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    300
  • sponsor
    Children's Hospital of Philadelphia
Updated on 1 March 2022
behavior modification
Accepts healthy volunteers

Summary

The purpose of this study is to address a decisional dilemma faced by health system officials, policy makers, and clinical leaders: "Does it make sense to integrate behavior therapy into primary care practice to treat children with ADHD from low-income settings? More specifically, does integrated care improve access to services and patient-centered outcomes for underserved children with ADHD?" Participants will be randomly assigned to one of two groups: Behavior therapy integrated into primary care (Partnering to Achieve School Success; PASS program) to treatment as usual (TAU) informed by American Academy of Pediatrics (AAP) guidelines for ADHD practice and facilitated by electronic practice supports." Participants will be 300 children (ages 5-11) with ADHD and their caregivers served at Children's Hospital of Philadelphia Care Network Locations (primary care offices). Participants are drawn from primary care locations that serve primarily low-income and racial/ethnic minority population.

Description

Context: Families of children with attention-deficit/hyperactivity disorder (ADHD) often have difficulty getting access to behavior therapy for their children. This project focuses on children and families of low-income, racial/ethnic minority background, who have particular difficulty getting access to behavior therapy. This study will compare enhanced behavior therapy integrated into primary care (known as Partnering to Achieve School Success [PASS]) to treatment as usual (TAU) informed by American Academy of Pediatrics (AAP) guidelines for the treatment of ADHD. In this study, behavior therapy will include components to address the unique needs of low-income families of minority status.

Objectives: This project is designed to improve family use of services for ADHD; improve children's academic achievement, behavioral compliance, interpersonal relationships, and life satisfaction; and reduce ADHD symptoms.

Study Design: The study is a randomized controlled trial.

Setting/Participants: The study is being conducted in five CHOP primary care practices serving a high percentage of families of low-income, racial/ethnic minority status. Participants will be children ages 5 to 11 with ADHD and in kindergarten through grade 5. Children will be randomly assigned to PASS or TAU plus family education, with 150 per group.

Study Interventions and Measures: PASS is a behavioral intervention for childhood ADHD that includes behavior therapy strategies and enhancements to promote family engagement in treatment, team-based care, and high-quality therapy. PASS uses a fully integrated service model that includes regular collaboration between the PASS provider and primary care provider (PCP). The primary outcomes are patient-centered outcomes pertaining to child academic achievement, behavior compliance, interpersonal relationships, and life satisfaction, as assessed by parent/legal guardian (or caregiver), child, and teacher rating. Secondary outcomes are informant ratings of ADHD symptoms.

Details
Condition ADHD
Treatment Partnering to Achieve School Success (PASS), Treatment as Usual (TAU) plus Family Education
Clinical Study IdentifierNCT04082234
SponsorChildren's Hospital of Philadelphia
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Children between the ages of 5 and 11 years
Children receiving care in one of the five targeted CHOP practices for this study
Children with an existing diagnosis of ADHD, as indicated by the referring primary care provider or behavioral health provider
Children with one or more areas of impairment (score of 3 or 4 on scale ranging from 1 to 4)
Children with at least one parent or legal guardian who is able to understand and speak English
Evidence that child may be in a family of low-income status, as indicated by child eligibility for Medicaid or Children's Health Insurance Program (CHIP) OR child living in a census tract or census block with median income at or below two times the federal poverty level
Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria

Child has autism spectrum disorder
Child has an intellectual disability
Child has a comorbid condition that is a major clinical concern and requires an alternative form of treatment
Child is receiving psychological therapy focused on parenting practices from another provider at the time of recruitment
Child has a sibling currently enrolled in the study
Child has received Healthy Minds, Healthy Kids (CHOP's Integrated Behavioral Health Service) in the past 6 months
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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