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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
Be at least 3 years old and no more than 8 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 16 weeks, 36 weeks
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 3 and 8 years old.
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I have never taken ADHD medication or have not found one that works for me.
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I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 16 weeks, 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 16 weeks, 36 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in child ADHD-related impairment
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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: 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
158 Previous Clinical Trials
46,128 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
221 Previous Clinical Trials
258,130 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
70 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
University of MichiganOTHER
1,853 Previous Clinical Trials
6,432,785 Total Patients Enrolled
6 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,005 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a CGI-S-ADHD rating ≥4 and <7.- Parent has had severe negative reactions to study medications in the past or has a history of substance abuse within the last three months.
- Parent has bipolar disorder, schizophrenia, psychoses, or other primary psychiatric disorder requiring immediate treatment.
- Parent has a chronic or acute medical disorder that makes stimulant therapy unsafe, such as glaucoma or hypertension.
- Parent has taken stimulant medication for ADHD within the last 30 days.
- Parent is pregnant.My child is 3-8 years old, may or may not have tried ADHD meds, and shows significant ADHD symptoms.You have ≥5 inactivity or ≥5 hyperactivity symptoms rated as 1 or 2 on the Vanderbilt ADHD Rating Scale.I am between 3 and 8 years old.I have never taken ADHD medication or have not found one that works for me.I am under 18 years old.The child has very severe ADHD symptoms with a score of more than 6 on a scale called CGI-S-ADHD.
Research Study Groups:
This trial has the following groups:- Group 1: Parent Stimulant Medication + Child Treatment Strategy
- Group 2: Child Treatment Strategy
Awards:
This trial has 4 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
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