Mindfulness-Based ADHD Treatment for Children: a Feasibility Study

NCT04737512 | Completed Early Phase 1 DMC

• 2 other identifiers: 20000207051R34AT009887-01A1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; mindfulness; meditation; children; feasibility; acceptability

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (8)

• 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)

Study Arms (3)

Mindfulness-Based ADHD Treatment for Children

EXPERIMENTAL

Behavioral: Mindfulness-Based ADHD Treatment for Children

Medication

ACTIVE COMPARATOR

Biological: Goal-Standard Medication (Treatment as Usual)

Combined (MBAT-C + medication)

ACTIVE COMPARATOR

Behavioral: Mindfulness-Based ADHD Treatment for Children; Biological: Goal-Standard Medication (Treatment as Usual)

Interventions

Mindfulness-Based ADHD Treatment for Children BEHAVIORAL

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.

Combined (MBAT-C + medication); Mindfulness-Based ADHD Treatment for Children

Goal-Standard Medication (Treatment as Usual) BIOLOGICAL

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.

Combined (MBAT-C + medication); Medication

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Clinical & Affective Neuroscience Lab

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Hedy Kober, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 4, 2021
• Study Start: February 1, 2021
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

US (1)