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Completed

NCT Number: NCT04737512

Mindfulness-Based ADHD Treatment for Children: a Feasibility Study

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.

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Key information

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Clinical & Affective Neuroscience Lab

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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:

  • 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.

Primary outcomes

  1. Recruitment

    Time frame: Completion of study (up to 30 months)

    Total number of participants enrolled

  2. Recruitment

    Time frame: Completion of study (up to 30 months)

    Average time from screening to enrollment

  3. Randomization

    Time frame: Completion of study (up to 30 months)

    Percent of eligible screened participants who enroll and are randomized

  4. Randomization

    Time frame: Completion of study (up to 30 months)

    Percent of enrolled who attend at least one session

  5. Attendance (MBAT-C Condition)

    Time frame: Post-Assessment (8-10 weeks)

    Average number of minutes attended

  6. Attendance (Medication Condition)

    Time frame: Post-Assessment (8-10 weeks)

    Average percent of scheduled medication visits attended

  7. Attendance (Combined Condition)

    Time frame: Post-Assessment (8-10 weeks)

    Average percent of MBAT-C and medication visits attended

  8. Attendance (Combined Condition)

    Time frame: Post-Assessment (8-10 weeks)

    Average number of minutes of MBAT-C attended

  9. Medication Adherence (for medication and combined conditions only)

    Time frame: Post-Assessment (8-10 weeks)

    Average percent of prescribed doses taken

  10. Retention

    Time frame: Post-Assessment (8-10 weeks)

    Percent of enrolled who attend >60% of study sessions

  11. Participation - Student Rated (for MBAT-C and combined conditions only)

    Time frame: Post-Assessment (8-10 weeks)

    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

  12. Participation - Teacher Rated (for MBAT-C and combined conditions only)

    Time frame: Post-Assessment (8-10 weeks)

    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

  13. Homework Completion (for MBAT-C and combined conditions only)

    Time frame: Post-Assessment (8-10 weeks)

    Average number of days per week practicing

  14. Homework Completion (for MBAT-C and combined conditions only)

    Time frame: Post-Assessment (8-10 weeks)

    Average number of total minutes practiced

  15. Acceptability

    Time frame: Post-Assessment (8-10 weeks)

    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

Secondary outcomes

  1. ADHD Symptoms

    Time frame: Post-Assessment (8-10 weeks)

    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

  2. Total Problems

    Time frame: Post-Assessment (8-10 weeks)

    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

  3. Externalizing Problems

    Time frame: Post-Assessment (8-10 weeks)

    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

  4. Attention

    Time frame: Post-Assessment (8-10 weeks)

    Pre-assessment to post-assessment difference on Flanker Task performance, as assessed by accuracy

  5. Executive Function

    Time frame: Post-Assessment (8-10 weeks)

    Pre-assessment to post-assessment difference on Hearts and Flowers Task, as assessed by accuracy

  6. Working Memory

    Time frame: Post-Assessment (8-10 weeks)

    Pre-assessment to post-assessment difference in performance on the List Sorting Working Memory Task, as assessed by accuracy

  7. Mindfulness

    Time frame: Post-Assessment (8-10 weeks)

    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

  8. Overall Improvement

    Time frame: Post-Assessment (8-10 weeks)

    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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: MBAT-C

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2021
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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