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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up)
Awards & highlights
PASS Trial 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.
PASS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
PASS Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Academic Progress
Changes in Behavior Compliance
Changes in Homework Performance
+4 moreSecondary outcome measures
Acceptability of PASS Delivery Modality
Changes in Family Empowerment
Changes in Parent-Child Relationship
+5 morePASS 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.
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Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,582,520 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
551 Previous Clinical Trials
29,997,158 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is being treated at one of the six CHOP practices involved in this study.My child has a serious health condition that needs a different treatment.My child has been diagnosed with ADHD by a healthcare provider.My child has significant impairment in one or more areas.My child is between 5 and 11 years old.I am between 5 and 11 years old.My child has been part of the Healthy Minds, Healthy Kids program recently.My child has a parent or guardian who speaks and understands English.
Research Study Groups:
This trial has the following groups:- Group 1: Integrated Individualized Behavioral Parent Training
- Group 2: Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the eligibility criteria for this clinical trial include individuals under 25 years old?
"This clinical trial is looking for participants from the age of 5 to 11. Moreover, there are a total of 98 studies that accept minors, and 28 available trials suitable for elderly patients."
Answered by AI
What therapeutic benefits are anticipated from this clinical trial?
"This clinical trial's primary goal is to measure the Modifications in Homework Performance of participants over baseline, 16 weeks post-treatment, and 32 weeks follow up. Secondary objectives include Assessing Family Empowerment utilizing the Service System factor from a 12 item scale with reliable coefficient alpha (.87) and test-retest reliability (.77), Perceptions of Team Based Care using a seven item version derived from Consumer Assessment of Healthcare Providers and Systems (CAHPS), as well as Measuring Treatment Satisfaction via modified versions of the Treatment Evaluation Inventory (TEI)."
Answered by AI
What is the size of the cohort participating in this clinical trial?
"Indeed, records on clinicaltrials.gov demonstrate that this particular medical trial is actively recruiting patients after its initial posting in November 2019 and final edit in October 2022. This study hopes to enrol 300 individuals from a single research centre."
Answered by AI
Is enrollment in this trial open to me?
"This trial is seeking 300 participants who are between ages 5 and 11 and have an official diagnosis of attention deficit hyperactivity disorder (ADHD)."
Answered by AI
Is enrollment for this clinical research opportunity still open?
"Affirmative. Clinicaltrials.gov reports that since its initial posting on November 1st 2019, this research trial has been actively recruiting participants. Currently the study seeks 300 volunteers at a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Children's Hospital of Philadelphia
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