Clinical trial NCT04082234: Reducing Disparities in Behavioral Health Treatment for Children in Primary Care
Official title: Reducing Disparities in Behavioral Health Treatment for Children in Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ADHD
Keywords: Behavior Therapy
Integrated Primary Care
Reducing Disparities
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2019-09-09
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Homework Performance
timeFrame: Baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up)
measure: Changes in Behavior Compliance
timeFrame: Baseline, 8-weeks (mid-treatment; parent only), 16-weeks (post-treatment), 32-weeks (follow-up)
measure: Changes in Symptoms of ADHD and Emotional and Behavioral Problems
timeFrame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
measure: Changes in Peer Relationships
timeFrame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
measure: Changes in Life Satisfaction
timeFrame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
measure: Changes in Service Use
timeFrame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Secondary outcomes:
measure: Changes in Parent-Child Relationship
timeFrame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
measure: Changes in Family Empowerment
timeFrame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
measure: Changes in Perceptions of Team-Based Care
timeFrame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
measure: Changes in Parent-Teacher Involvement
timeFrame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
measure: Satisfaction with Treatment
timeFrame: 16-weeks (post-treatment)
measure: Acceptability of PASS Delivery Modality
timeFrame: 16-weeks (post-treatment)
measure: Cultural Humility of Provider
timeFrame: 16-weeks (post-treatment)
measure: Post-Treatment Interview
timeFrame: 16-weeks (post-treatment)
measure: Changes in Academic Progress
timeFrame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
measure: Changes in Behavior Compliance
timeFrame: Baseline, 8-weeks (mid-treatment; parent only), 16-weeks (post-treatment), 32-weeks (follow-up)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jennifer A Mautone, PhD, NCSP, ABPP
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Thomas J Power, PhD
role: PRINCIPAL_INVESTIGATOR
References: