Reducing Disparities in Behavioral Health Treatment for Children in Primary Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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 seven 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. Children will be randomly assigned to PASS or TAU, 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), and child rating. Secondary outcomes are informant ratings of ADHD symptoms.

Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Integrated Individualized Behavioral Parent Training

Partnering to Achieve School Success (PASS) is a personalized, enhanced behavioral intervention for ADHD that includes evidence-based behavior therapy strategies and enhancements to promote family engagement in treatment, team-based care, and high quality therapy. Caregivers engage in up to 12 sessions with a behavioral health provider over the course of 16 weeks that are specifically tailored to caregiver goals and values.

Group Type EXPERIMENTAL

Partnering to Achieve School Success (PASS)

Intervention Type BEHAVIORAL

Individualized parent training program delivered at child's primary care provider office. Providers use engagement and motivation strategies during each session to reinforce help-seeking behavior and family empowerment, and encourage family adherence to recommended strategies. Also includes regular communication between pass provider and PCP and development of a problem-solving partnership between parents and teachers to address school problems. Families are supported in between sessions by a Community Health Partner who contacts families to promote attendance and implementation of strategies and assist in resolving barriers to treatment. The intervention is up to 12 sessions over the course of 16 weeks depending on caregiver goals.

Treatment as Usual

The control condition will be TAU informed by AAP guidelines for managing ADHD and facilitated by electronic practice supports, which have been successfully incorporated into the electronic health record (EHR) to guide primary care providers (PCPs) in implementing ADHD guidelines. At CHOP, PCPs across the primary care network were invited to participate in a distance learning, quality improvement initiative to promote implementation of AAP guidelines, including strategies to educate families about ADHD and evidence-based treatments, engage families in shared decision making, titrate medication, and monitor treatment effects. The six practices participating in this study participated in that project.

Group Type ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type OTHER

Caregivers will work with their primary care physician to address their child's ADHD. Primary care physicians have been trained in and informed of American Academy of Pediatrics guidelines for treating ADHD. Treatment may include strategies to educate families about ADHD and evidence-based treatments, refer families to community mental health agencies that deliver evidence-based behavioral programming (other than PASS), engage families in shared decision making, titrate medication, and monitor treatment effects. In addition, families will have access to integrated behavioral health services that are typically offered at their child's primary care office.

Interventions

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Partnering to Achieve School Success (PASS)

Individualized parent training program delivered at child's primary care provider office. Providers use engagement and motivation strategies during each session to reinforce help-seeking behavior and family empowerment, and encourage family adherence to recommended strategies. Also includes regular communication between pass provider and PCP and development of a problem-solving partnership between parents and teachers to address school problems. Families are supported in between sessions by a Community Health Partner who contacts families to promote attendance and implementation of strategies and assist in resolving barriers to treatment. The intervention is up to 12 sessions over the course of 16 weeks depending on caregiver goals.

Intervention Type BEHAVIORAL

Treatment as Usual (TAU)

Caregivers will work with their primary care physician to address their child's ADHD. Primary care physicians have been trained in and informed of American Academy of Pediatrics guidelines for treating ADHD. Treatment may include strategies to educate families about ADHD and evidence-based treatments, refer families to community mental health agencies that deliver evidence-based behavioral programming (other than PASS), engage families in shared decision making, titrate medication, and monitor treatment effects. In addition, families will have access to integrated behavioral health services that are typically offered at their child's primary care office.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children between the ages of 5 and 11 years (as reported in EHR at the time of referral to the study team)
* Children receiving care in one of the seven 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 and/or EHR)
* Children with one or more areas of impairment (score of 3 or 4 on scale ranging from 1 to 4)
* 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 behavioral health services 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

Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes