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ADHD Medication + Parent Training for ADHD Families (TPAC Trial)

Phase 3
Recruiting
Led By Andrea Chronis-Tuscano, Ph.D.
Research Sponsored by University of Maryland, College Park
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Parent: Be at least 21 years old and English-speaking, Meet full DSM-5 criteria for ADHD (any subtype), Have findings on physical examination, laboratory studies, vital signs, and electrocardiogram judged to be normal for age with no contraindications for stimulant medication, Have pulse and blood pressure (BP) within 95% of age and gender mean, Women of childbearing potential agree to use a medically accepted contraception method consistently, Parents with common comorbid conditions will be included provided that: (a) they do not report active suicidal ideation with intent (i.e. Beck Depression Inventory (BDI)-II score of 2 or 3 to Q9 which assesses suicidal thoughts); and (b) if receiving an antidepressant medication, their medication is well-tolerated, has not changed within 30 days, and the prescribing physician approves of their participation in the study, Must have regular access to a computer or phone that can be used to deliver the behavioral parent training
Child: Be at least 3 years old and no more than 8 years old, ADHD medication naive or have not had an adequate trial of stimulant medications, Have ≥5 inactivity or ≥5 hyperactivity symptoms rated as 1 or 2 on the Vanderbilt, Have a CGI-S-ADHD rating ≥4 and <7
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 16 weeks, 36 weeks
Awards & highlights

TPAC Trial Summary

This trial will compare the effectiveness of treating ADHD in children when their parent also has ADHD, versus treating the child's ADHD alone. They will also study the parents' ADHD symptoms and how well they are able to engage in parent training.

Who is the study for?
This trial is for parents over 21 with ADHD and their children aged 3-8 who may also have ADHD symptoms. Parents must meet full criteria for ADHD, be in good physical health, not pregnant, and agree to use contraception if applicable. Children should not have been on stimulant medications before or only tried them without success.Check my eligibility
What is being tested?
The study tests if combining a stimulant drug (MAS) for the parent with behavioral training improves child's ADHD-related issues more than just training alone. It will look at how this affects both the child’s behavior and the parent's ADHD symptoms when delivered via telehealth.See study design
What are the potential side effects?
Potential side effects of MAS can include decreased appetite, difficulty sleeping, headaches, jitteriness, mood swings or irritability. Behavioral Parent Training does not involve medication so it has no direct medical side effects.

TPAC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is 3-8 years old, may or may not have tried ADHD meds, and shows significant ADHD symptoms.
Select...
I am between 3 and 8 years old.
Select...
I have never taken ADHD medication or have not found one that works for me.
Select...
I am under 18 years old.

TPAC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 16 weeks, 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 16 weeks, 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in child ADHD-related impairment

TPAC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Parent Stimulant Medication + Child Treatment StrategyExperimental Treatment2 Interventions
Parent stimulant medication first followed by a child treatment strategy consisting of behavioral parent training followed by a recommendation for child stimulant medication to the primary care provider if the child remains impaired.
Group II: Child Treatment StrategyActive Control1 Intervention
Child treatment strategy consisting of behavioral parent training followed by a recommendation for child stimulant medication to the primary care provider if the child remains impaired. In this arm, parents do not receive stimulant medication before behavioral parent training.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Parent Training
2013
Completed Phase 4
~590

Find a Location

Who is running the clinical trial?

University of Maryland, College ParkLead Sponsor
154 Previous Clinical Trials
45,245 Total Patients Enrolled
4 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
271 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Children's National Research InstituteOTHER
209 Previous Clinical Trials
207,505 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
70 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
University of MichiganOTHER
1,787 Previous Clinical Trials
6,365,294 Total Patients Enrolled
6 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,005 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Behavioral Parent Training Clinical Trial Eligibility Overview. Trial Name: NCT04240756 — Phase 3
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Child Treatment Strategy, Parent Stimulant Medication + Child Treatment Strategy
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Behavioral Parent Training Highlights & Side Effects. Trial Name: NCT04240756 — Phase 3
Behavioral Parent Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04240756 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the requirements to partake in this experiment?

"To be eligible for this study, potential participants must meet the following requirements: parents must be between the ages of 3-65, the child must be between the ages of 3-8, the child cannot have had an adequate trial of stimulant medications, the child must have ≥5 inactivity or ≥5 hyperactivity symptoms rated as 1 or 2 on the Vanderbilt, and the child must have a CGI-S-ADHD rating ≥4 and <7."

Answered by AI

What are some reasons why parents might enroll their children in Behavioral Parent Training?

"Behavioral Parent Training is a form of treatment that has been shown to be effective against conditions like pain, ADHD, and narcolepsy."

Answered by AI

Are there any other research projects that focus on Behavior Parent Training?

"Currently, there are 9 ongoing trials for Behavioral Parent Training with 2 trials in Phase 3. Most trials for this Behavioral Parent Training are taking place in Seattle, but there are a total of 14 locations running these trials."

Answered by AI

At what age does this research study cutoff recruitment for participants?

"As this medical study's inclusion criteria state, the minimum age requirement for enrollment is 3 years old while the maximum is 65."

Answered by AI

Has the FDA cleared Behavioral Parent Training for use?

"We have rated the safety of Behavioral Parent Training as a 3. This is based on the fact that this is a Phase 3 trial, meaning that there is some data supporting efficacy as well as multiple rounds of data supporting safety."

Answered by AI

Are there any available slots for new subjects in this research?

"The clinical trial is currently enrolling patients, with the latest update on the website being from 4/23/2021. The study is looking for 240 patients to be split between 2 locations."

Answered by AI

Could you tell me how many people are included in this clinical trial?

"Yes, the information available on clinicaltrials.gov suggests that this trial is enrolling patients at this time. This trial was first posted on August 6th, 2020 and was most recently updated on April 23rd, 2021. The study is looking for 240 patients from 2 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Georgia
Washington
Other
How old are they?
18 - 65
What site did they apply to?
University of Maryland
Seattle Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
~11 spots leftby May 2024