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Mindfulness-Based Therapy for ADHD (MBAT-C Trial)
Phase < 1
Recruiting
Led By Hedy Kober, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Must not have
Any conditions contraindicated for ADHD medications, or potential participants taking monoamine-oxidase inhibitors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of study (up to 30 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial will help researchers understand if MBAT-C is a promising intervention for children with ADHD and whether a larger clinical trial is warranted.
Who is the study for?
This study is for children aged 7-13 with ADHD who can understand and agree to the study's requirements. They must be able to stop any current ADHD medications if needed, speak English, and have parental consent. Children cannot join if they are pregnant, have certain physical conditions, take specific drugs that don't mix well with standard ADHD medication or are on monoamine-oxidase inhibitors.
What is being tested?
The trial tests a new Mindfulness-Based Treatment (MBAT-C) against the usual medication treatment for ADHD in kids. It will also look at combining both treatments. The goal is to see how practical and acceptable MBAT-C is when compared to traditional methods.
What are the potential side effects?
While mindfulness-based therapy typically doesn't cause side effects like medicines do, standard ADHD medications may lead to appetite changes, sleep problems, headaches or stomachaches among others.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I don't have conditions that make ADHD medications unsafe for me, and I'm not taking monoamine-oxidase inhibitors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of study (up to 30 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of study (up to 30 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Attendance (Combined Condition)
Attendance (MBAT-C Condition)
+8 moreSecondary study objectives
ADHD Symptoms
Attention
Executive Function
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based ADHD Treatment for ChildrenExperimental Treatment1 Intervention
Group II: MedicationActive Control1 Intervention
Group III: Combined (MBAT-C + medication)Active Control2 Interventions
Find a Location
Who is running the clinical trial?
National Center for Complementary and Integrative Health (NCCIH)NIH
854 Previous Clinical Trials
671,695 Total Patients Enrolled
4 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
206 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,637 Total Patients Enrolled
5 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
208 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Hedy Kober, PhDPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with ADHD with symptoms like inattention, hyperactivity, or both, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).If you are currently taking medication for ADHD, you must be willing to stop taking it for a certain period of time before starting the trial.You have been diagnosed with ADHD based on the specific symptoms outlined in the Diagnostic Statistical Manual -5 (DSM-5).I don't have conditions that make ADHD medications unsafe for me, and I'm not taking monoamine-oxidase inhibitors.I am willing to be assigned to a treatment group by chance.I am a parent of a child aged 7-13.You have certain physical conditions that may make it difficult for you to take part in the study.My child is between 7 and 13 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Medication
- Group 2: Combined (MBAT-C + medication)
- Group 3: Mindfulness-Based ADHD Treatment for Children
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.
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