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ADHD Medication + Parent Training for ADHD Families (TPAC Trial)
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.
TPAC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTPAC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TPAC Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Child Treatment Strategy
- Group 2: Parent Stimulant Medication + Child Treatment Strategy
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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."
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