Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
ADHD
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 5 years and 11 years
Gender
Both males and females

Description

Context: Families of children with attention-deficit/hyperactivity disorder (ADHD) often have difficulty getting access to behavior therapy for their children. The project focuses on children and families of low-income, racial/ethnic minority background, who have particular difficulty getting access...

Context: Families of children with attention-deficit/hyperactivity disorder (ADHD) often have difficulty getting access to behavior therapy for their children. The 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 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 plus family education. 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, child, and teacher rating. Secondary outcomes are informant ratings of ADHD symptoms.

Tracking Information

NCT #
NCT04082234
Collaborators
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Jennifer A Mautone, PhD, NCSP, ABPP Children's Hospital of Philadelphia Principal Investigator: Thomas J Power, PhD Children's Hospital of Philadelphia