Mindfulness-Based ADHD Treatment for Children: a Feasibility Study (MBAT-C)

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: Mindfulness-Based ADHD Treatment for Children; Biological: Goal-Standard Medication (Treatment as Usual)

Detailed Description

Attention-Deficit/Hyperactivity Disorder (ADHD) affects 11% of American children. ADHD is a source of considerable psychosocial, educational, and neurocognitive impairment. It is co-morbid with multiple psychiatric disorders and poses an economic burden. Pharmacotherapy is often the first-line treatment for children with ADHD, but such medications are associated with adverse effects, including insomnia, loss of appetite, headaches, stomachaches, tics, moodiness, and irritability. Further, concerns about substance misuse and diversion, as well as parental preference, can limit the use and utility of medications. These limitations underscore the urgency of developing behavioral interventions that do not pose such concerns. At this time, however, behavioral treatments for ADHD are generally less effective than pharmacotherapy, emphasizing the need for better non-pharmacologic interventions.

Mindfulness-defined here as nonjudgmentally paying attention to the present moment-is a promising behavioral approach to ADHD treatment, as evidence suggests that mindfulness improves attention in both healthy adults, and those with ADHD. Mindfulness also improves neurocognitive outcomes in children and adolescents, including executive function and attention, suggesting that mindfulness may be an effective treatment for ADHD in young persons.

This is a feasibility study of a novel intervention: Mindfulness-Based ADHD Treatment for Children (MBAT-C). 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. Specifically, MBAT-C includes 16 twice-weekly 30-minute sessions over 8 weeks. Each session includes two brief meditations, discussion, an exercise, and homework.

In this study, 45 children ages 7-13 with ADHD will be randomized into one of three treatment groups: MBAT-C, medication (MED), or a combined intervention (COM).

The aims of the study are as follows:

Aim 1: Evaluate feasibility of MBAT-C

Aim 2. Measure within-group change from pre- to post-treatment on ADHD-relevant outcomes.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Clinical & Affective Neuroscience Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• child of any sex/gender ages 7-13;
• fulfills the Diagnostic Statistical Manual -5 criteria for ADHD (inattentive, hyperactive, or combined);
• speaks English;
• understands the assent form and provides informed assent;
• has parents who understand the consent form and provide informed consent;
• can commit to the full length of the protocol;
• is willing to undergo a wash-out period if already on ADHD medications;
• is willing to be randomized to treatment condition.

Exclusion criteria include:

• physical conditions that may preclude participation;
• any conditions contraindicated for ADHD medications, or potential participants taking monoamine-oxidase inhibitors;
• pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based ADHD Treatment for Children	Behavioral: Mindfulness-Based ADHD Treatment for Children; 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.
Active Comparator: Medication	Biological: Goal-Standard Medication (Treatment as Usual); 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: All participants will start with Concerta; Ritalin may be started if the effect of Concerta wears off mid-day;; 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;; If Vyvanse +/- Adderall is also ineffective or not tolerated, participants will progress to Kapvay;; If Kapvay is ineffective or not tolerated, participants will progress to Intuniv.; Alternative combinations of the above medications will be considered if the above combinations are ineffective or otherwise not tolerated.
Active Comparator: Combined (MBAT-C + medication)	Behavioral: Mindfulness-Based ADHD Treatment for Children; 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.; Biological: Goal-Standard Medication (Treatment as Usual); 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: All participants will start with Concerta; Ritalin may be started if the effect of Concerta wears off mid-day;; 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;; If Vyvanse +/- Adderall is also ineffective or not tolerated, participants will progress to Kapvay;; If Kapvay is ineffective or not tolerated, participants will progress to Intuniv.; Alternative combinations of the above medications will be considered if the above combinations are ineffective or otherwise not tolerated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD Symptoms	Pre-assessment to post-assessment difference on ADHD Rating Scale (ADHD-RS); the ADHD-RS is an 18-item scale that assess core ADHD symptoms as reported by parents, with scores ranging from 0 to 54; higher scores indicate greater ADHD symptoms	Post-Assessment (8-10 weeks)
Total Problems	Pre-assessment to post-assessment difference in the total score on the total problems subscale on the Child Behavior Checklist (CBCL), which is comprised of 98 questions; individual item scores range from 0 to 2; higher scores indicate higher amount of behavioral problems	Post-Assessment (8-10 weeks)
Externalizing Problems	Pre-assessment to post-assessment difference in score on the externalizing problems subscale on the Child Behavior Checklist (CBCL), which is comprised of 33 questions; individual item scores range from 0 to 2; higher scores indicate higher amount of externalizing problems	Post-Assessment (8-10 weeks)
Attention	Pre-assessment to post-assessment difference on Flanker Task performance, as assessed by accuracy	Post-Assessment (8-10 weeks)
Executive Function	Pre-assessment to post-assessment difference on Hearts and Flowers Task, as assessed by accuracy	Post-Assessment (8-10 weeks)
Working Memory	Pre-assessment to post-assessment difference in performance on the List Sorting Working Memory Task, as assessed by accuracy	Post-Assessment (8-10 weeks)
Mindfulness	Pre-assessment to post-assessment difference in score on the Child and Adolescent Mindfulness Measure (CAMM); the CAMM is a 10-item measure of self-reported mindfulness; scores range from 0 to 40, with higher scores indicating higher mindfulness	Post-Assessment (8-10 weeks)
Overall Improvement	Score on the Clinical Global Impression - Improvement (CGI-I) scale; the CGI-I is a 1 item measure of improvement from pre- to post-intervention, as assessed by a clinician; scores range from 0-7, with lower scores indicating greater improvement	Post-Assessment (8-10 weeks)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Hedy Kober, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): October 29, 2024
• Study Completion (Actual): October 29, 2024

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: ADHD; children; mindfulness; meditation; feasibility; acceptability
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 2000020705; 1R34AT009887-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No