What side effects are associated with this type of intervention?

Behavioral interventions for ADHD, such as those integrated into primary care, typically have minimal side effects but require significant time and effort. Stimulant medications like methylphenidate and amphetamines can cause insomnia, decreased appetite, weight loss, increased heart rate, and potential for substance misuse. Non-stimulant medications like atomoxetine may cause gastrointestinal issues, fatigue, and mood swings. Combining behavioral therapy with medication can help reduce some side effects by allowing for lower medication doses.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including stimulant medications like methylphenidate (e.g., Ritalin, Concerta) and amphetamines (e.g., Adderall). Non-stimulant medications such as atomoxetine (Strattera) and extended-release guanfacine (Intuniv) have also been approved. These medications help manage core symptoms of ADHD and are often used in combination with behavioral therapies. Behavioral interventions, such as those integrated into primary care settings, focus on structured behavioral strategies and psychoeducation to improve patient outcomes. These combined approaches aim to enhance access to care and provide comprehensive treatment for children with ADHD, particularly in underserved populations.

What other types of research exist?

Promising novel alternatives to Behavior Therapy Integrated into Primary Care for ADHD patients include: 1) Bibliotherapy as an adjunct to stimulant medication, which is cost-effective and enhances parental knowledge of behavioral principles. 2) Telepsychiatry combined with pharmacotherapy and behavior training, which has shown superior outcomes in randomized controlled trials. 3) Cogmed Working Memory Training, either alone or combined with pharmacotherapy, offering a non-pharmacological option. 4) New stimulant formulations, providing personalized medication options within a patient-centered medical home.

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Behavior Therapy for ADHD in Primary Care (PASS Trial)

N/A

Recruiting

Led By Jennifer A Mautone, PhD, NCSP, ABPP

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

No Placebo-Only Group

Summary

This trial tests a special behavior therapy provided in the doctor's office for low-income children with ADHD. The therapy works closely with the child's regular doctor to help improve behavior, school performance, and relationships.

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.

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.

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

Select...

My child has significant impairment in one or more areas.

Select...

My child is between 5 and 11 years old.

Select...

I am between 5 and 11 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child has a serious health condition that needs a different treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Homework Performance

Changes in Life Satisfaction

Changes in Peer Relationships

+2 more

Secondary study objectives

Acceptability of PASS Delivery Modality

Changes in Academic Progress

Changes in Behavior Compliance

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met

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].