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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of study (up to 30 months)
Awards & highlights

MBAT-C Trial 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.Check my eligibility
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.See study design
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.

MBAT-C Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of study (up to 30 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of study (up to 30 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability
Attendance (Combined Condition)
Attendance (MBAT-C Condition)
+8 more
Secondary outcome measures
ADHD Symptoms
Attention
Executive Function
+5 more

MBAT-C 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
832 Previous Clinical Trials
668,889 Total Patients Enrolled
4 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
206 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,321 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

Mindfulness-Based ADHD Treatment for Children (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04737512 — Phase < 1
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Medication, Combined (MBAT-C + medication), Mindfulness-Based ADHD Treatment for Children
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Mindfulness-Based ADHD Treatment for Children Highlights & Side Effects. Trial Name: NCT04737512 — Phase < 1
Mindfulness-Based ADHD Treatment for Children (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04737512 — Phase < 1

Frequently Asked Questions

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

Is the program actively seeking out participants?

"According to clinicaltrials.gov, this medical trial is still seeking participants since its initial posting on February 1st 2021 and most recent update on June 14th 2022."

Answered by AI

What objectives are being pursued with this clinical experiment?

"This study will primarily be assessing patient Retention over an 8-10 week period. Secondary evaluations include Attention, gauged by accuracy on a Flanker Task; ADHD Symptoms measured with the 18-item ADHD Rating Scale (ADHD-RS); and Total Problems evaluated through scores obtained from the Child Behavior Checklist (CBCL)'s 98 questions subscale."

Answered by AI

Who has been approved to partake in this clinical investigation?

"This trial requires 45 minors between the ages of 7 and 13 that have been diagnosed with ADHD to partake. The eligibility requirements are as follows: child of any gender, commitment to the entire protocol duration, willingness for a drug wash-out period if already on medications, and acceptance in being randomized into treatment groups."

Answered by AI

Does the research team have age restrictions, and if so, what are they?

"Participants must meet the age criteria of this trial, which requires that they are between 7 and 13 years old."

Answered by AI

What is the total sample size of this research trial?

"Affirmative. According to clinicaltrials.gov, this medical examination is actively seeking participants; it was initially advertised on February 1st 2021 and the date of its most recent update was June 14th 2022. The trial requires 45 individuals from one specific site."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical & Affective Neuroscience Lab
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Jun 2024