NCT04737512|CompletedEarly Phase 1DMC
Mindfulness-Based ADHD Treatment for Children: a Feasibility Study
MBAT-C
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MBAT-C
Sponsor study identifier
Secondary identifiers
interventional
68
1 country
1
Study Start
February 1, 2021
Actual (reported)Primary Completion
October 29, 2024
Actual (reported)Study Completion
October 29, 2024
Actual (reported)Attention-Deficit/Hyperactivity Disorder (ADHD) affects 11% of children and leads to adverse outcomes. Medications, while often effective in reducing certain ADHD symptoms, have many disadvantages, including misuse and side effects. Behavioral interventions do not have these adverse effects, but they are not as effective. Mindfulness is a candidate intervention for ADHD in elementary school children, but has not been systematically and rigorously studied. This study will evaluate the feasibility and acceptability of Mindfulness-Based ADHD Treatment for Children (MBAT-C). MBAT-C is designed for children at precisely the age when ADHD-relevant neurocognitive systems are developing and clinical symptoms begin to appear. Forty-five children from the New Haven, CT area, ages 7-13, will be recruited to participate in this randomized-controlled feasibility trial that will compare MBAT-C, medication, and a combined intervention.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 29, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 15, 2021
Actual (reported)February 1, 2021
Actual (reported)February 4, 2021
Actual (reported)October 29, 2024
Actual (reported)October 29, 2024
Actual (reported)Recruitment
Total number of participants enrolled
Completion of study (up to 30 months)
Recruitment
Average time from screening to enrollment
Completion of study (up to 30 months)
Randomization
Percent of eligible screened participants who enroll and are randomized
Completion of study (up to 30 months)
Randomization
Percent of enrolled who attend at least one session
Completion of study (up to 30 months)
ADHD Symptoms
Post-Assessment (8-10 weeks)
Total Problems
Post-Assessment (8-10 weeks)
Externalizing Problems
Post-Assessment (8-10 weeks)
Attention
Post-Assessment (8-10 weeks)
Executive Function
Post-Assessment (8-10 weeks)
MBAT-C is derived from Mindfulness-Based Stress Reduction (MBSR), a well-known and extensively-studied mindfulness intervention. Unlike all other mindfulness-based interventions, however, MBAT-C is tailored to the needs, abilities, and vulnerabilities of children with ADHD through the use of age-appropriate class length, homework assignments, contemplative practices, and discussion topics.
Clinical & Affective Neuroscience Lab
New Haven, Connecticut, 06510, United States
Hedy Kober, PhD
Yale University
68 participants (actual enrollment reported by the registry).
First Submitted
January 15, 2021
First Posted
February 4, 2021
Study Start
February 1, 2021
Actual (reported)Procedural Learning in Participants With ADHD
Attendance (MBAT-C Condition)
Average number of minutes attended
Post-Assessment (8-10 weeks)
Attendance (Medication Condition)
Average percent of scheduled medication visits attended
Post-Assessment (8-10 weeks)
Attendance (Combined Condition)
Average percent of MBAT-C and medication visits attended
Post-Assessment (8-10 weeks)
Attendance (Combined Condition)
Average number of minutes of MBAT-C attended
Post-Assessment (8-10 weeks)
Medication Adherence (for medication and combined conditions only)
Average percent of prescribed doses taken
Post-Assessment (8-10 weeks)
Retention
Percent of enrolled who attend \>60% of study sessions
Post-Assessment (8-10 weeks)
Participation - Student Rated (for MBAT-C and combined conditions only)
Average student ratings of participation of each MBAT-C session, as measured by the Research Assessment Package for Schools - Student (RAPS-SE); RAPS-SE is a 6 item measure with individual item scores ranging from 1 to 4; overall score is average of 3 individual items; higher scores indicate higher participation
Post-Assessment (8-10 weeks)
Participation - Teacher Rated (for MBAT-C and combined conditions only)
Average teacher ratings of participation of each MBAT-C session, as measured by the Research Assessment Package for Schools - Teacher Engagement (RAPS-TE); RAPS-TE is a 3 item measure of participation with individual item scores ranging from 1 to 4; overall score is average of 3 individual items; higher scores indicate greater participation
Post-Assessment (8-10 weeks)
Homework Completion (for MBAT-C and combined conditions only)
Average number of days per week practicing
Post-Assessment (8-10 weeks)
Homework Completion (for MBAT-C and combined conditions only)
Average number of total minutes practiced
Post-Assessment (8-10 weeks)
Acceptability
Average score on Acceptability of Intervention Measure (AIM); AIM is a 4 item measure of acceptability with individual item scores ranging from 1-4; overall score is sum of individual items; higher scores indicate higher acceptability
Post-Assessment (8-10 weeks)
Participants will receive gold-standard, non-experimental medication. This treatment arm relies on a step-by-step approach that is designed to mimic pharmacologic treatment-as-usual in the community. The treatment algorithm is as follows: 1. All participants will start with Concerta; Ritalin may be started if the effect of Concerta wears off mid-day; 2. If Concerta +/- Ritalin is ineffective or not tolerated, participants will progress to Vyvanse; Adderall may be started if the effect of Vyvanse wears off mid-day; 3. If Vyvanse +/- Adderall is also ineffective or not tolerated, participants will progress to Kapvay; 4. If Kapvay is ineffective or not tolerated, participants will progress to Intuniv. 5. Alternative combinations of the above medications will be considered if the above combinations are ineffective or otherwise not tolerated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 29, 2024
Actual (reported)Study Completion
October 29, 2024
Actual (reported)Last Updated
November 25, 2024
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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