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Behavior Therapy for ADHD in Primary Care (PASS Trial)

N/A
Recruiting
Led By Thomas J Power, PhD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children with one or more areas of impairment (score of 3 or 4 on scale ranging from 1 to 4)
Children between the ages of 5 and 11 years (as reported in EHR at the time of referral to the study team)
Must not have
Child has a comorbid condition that is a major clinical concern and requires an alternative form of treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up)
Awards & highlights

Summary

This trial is testing whether or not it is helpful to integrate behavior therapy into primary care for children with ADHD from low-income settings.

Who is the study for?
This trial is for children aged 5-11 with ADHD from low-income families, primarily served at CHOP Care Network Locations. Eligible participants must have an ADHD diagnosis and significant impairment in daily activities. They should not be receiving other behavioral treatments or have autism, intellectual disabilities, or conditions needing different treatment.Check my eligibility
What is being tested?
The study compares two approaches to treating ADHD in underserved kids: the PASS program which integrates behavior therapy into primary care versus the usual treatment informed by AAP guidelines. The goal is to see if integrated care improves access and outcomes for these children.See study design
What are the potential side effects?
As this trial focuses on behavioral interventions rather than medication, side effects are not typical as with drug trials but may include potential stress or discomfort related to therapy sessions or changes in routine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child has significant impairment in one or more areas.
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My child is between 5 and 11 years old.
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I am between 5 and 11 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My child has a serious health condition that needs a different treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Homework Performance
Changes in Life Satisfaction
Changes in Peer Relationships
+2 more
Secondary outcome measures
Acceptability of PASS Delivery Modality
Changes in Academic Progress
Changes in Behavior Compliance
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Individualized Behavioral Parent TrainingExperimental Treatment1 Intervention
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 II: Treatment as UsualActive Control1 Intervention
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for ADHD include pharmacological and behavioral interventions. Stimulant medications like methylphenidate and amphetamines increase dopamine and norepinephrine levels in the brain, improving attention and reducing impulsivity and hyperactivity. Non-stimulant medications such as atomoxetine inhibit the reuptake of norepinephrine. Behavioral interventions, such as those in the Behavior Therapy Integrated into Primary Care trial, focus on modifying the environment and teaching coping strategies, including structured routines and positive reinforcement. These treatments are essential for addressing both neurochemical imbalances and behavioral challenges, leading to more effective management of ADHD.
Bibliotherapy as an adjunct to stimulant medication in the treatment of attention-deficit hyperactivity disorder.[Multimodal treatment of attention-deficit hyperactivity disorder in children].

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
712 Previous Clinical Trials
8,589,717 Total Patients Enrolled
6 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
2,148 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Patient-Centered Outcomes Research InstituteOTHER
563 Previous Clinical Trials
29,991,850 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
948 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Thomas J Power, PhDPrincipal InvestigatorChildren's Hospital of Philadelphia

Media Library

Partnering to Achieve School Success (PASS) Clinical Trial Eligibility Overview. Trial Name: NCT04082234 — N/A
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Integrated Individualized Behavioral Parent Training, Treatment as Usual
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Partnering to Achieve School Success (PASS) Highlights & Side Effects. Trial Name: NCT04082234 — N/A
Partnering to Achieve School Success (PASS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04082234 — N/A
~70 spots leftby Dec 2025