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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based ADHD Treatment for Children
Goal-Standard Medication (Treatment as Usual)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, mindfulness, meditation, children, feasibility, acceptability

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical & Affective Neuroscience LabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Mindfulness-Based ADHD Treatment for Children

Medication

Combined (MBAT-C + medication)

Arm Description

Outcomes

Primary Outcome Measures

Recruitment
Total number of participants enrolled
Recruitment
Average time from screening to enrollment
Randomization
Percent of eligible screened participants who enroll and are randomized
Randomization
Percent of enrolled who attend at least one session
Attendance (MBAT-C Condition)
Average number of minutes attended
Attendance (Medication Condition)
Average percent of scheduled medication visits attended
Attendance (Combined Condition)
Average percent of MBAT-C and medication visits attended
Attendance (Combined Condition)
Average number of minutes of MBAT-C attended
Medication Adherence (for medication and combined conditions only)
Average percent of prescribed doses taken
Retention
Percent of enrolled who attend >60% of study sessions
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
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
Homework Completion (for MBAT-C and combined conditions only)
Average number of days per week practicing
Homework Completion (for MBAT-C and combined conditions only)
Average number of total minutes practiced
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

Secondary Outcome Measures

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
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
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
Attention
Pre-assessment to post-assessment difference on Flanker Task performance, as assessed by accuracy
Executive Function
Pre-assessment to post-assessment difference on Hearts and Flowers Task, as assessed by accuracy
Working Memory
Pre-assessment to post-assessment difference in performance on the List Sorting Working Memory Task, as assessed by accuracy
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
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

Full Information

First Posted
January 15, 2021
Last Updated
July 11, 2023
Sponsor
Yale University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04737512
Brief Title
Mindfulness-Based ADHD Treatment for Children: a Feasibility Study
Acronym
MBAT-C
Official Title
Mindfulness-Based ADHD Treatment for Children: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, mindfulness, meditation, children, feasibility, acceptability

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based ADHD Treatment for Children
Arm Type
Experimental
Arm Title
Medication
Arm Type
Active Comparator
Arm Title
Combined (MBAT-C + medication)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based ADHD Treatment for Children
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Goal-Standard Medication (Treatment as Usual)
Intervention Description
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 Outcome Measure Information:
Title
Recruitment
Description
Total number of participants enrolled
Time Frame
Completion of study (up to 30 months)
Title
Recruitment
Description
Average time from screening to enrollment
Time Frame
Completion of study (up to 30 months)
Title
Randomization
Description
Percent of eligible screened participants who enroll and are randomized
Time Frame
Completion of study (up to 30 months)
Title
Randomization
Description
Percent of enrolled who attend at least one session
Time Frame
Completion of study (up to 30 months)
Title
Attendance (MBAT-C Condition)
Description
Average number of minutes attended
Time Frame
Post-Assessment (8-10 weeks)
Title
Attendance (Medication Condition)
Description
Average percent of scheduled medication visits attended
Time Frame
Post-Assessment (8-10 weeks)
Title
Attendance (Combined Condition)
Description
Average percent of MBAT-C and medication visits attended
Time Frame
Post-Assessment (8-10 weeks)
Title
Attendance (Combined Condition)
Description
Average number of minutes of MBAT-C attended
Time Frame
Post-Assessment (8-10 weeks)
Title
Medication Adherence (for medication and combined conditions only)
Description
Average percent of prescribed doses taken
Time Frame
Post-Assessment (8-10 weeks)
Title
Retention
Description
Percent of enrolled who attend >60% of study sessions
Time Frame
Post-Assessment (8-10 weeks)
Title
Participation - Student Rated (for MBAT-C and combined conditions only)
Description
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
Time Frame
Post-Assessment (8-10 weeks)
Title
Participation - Teacher Rated (for MBAT-C and combined conditions only)
Description
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
Time Frame
Post-Assessment (8-10 weeks)
Title
Homework Completion (for MBAT-C and combined conditions only)
Description
Average number of days per week practicing
Time Frame
Post-Assessment (8-10 weeks)
Title
Homework Completion (for MBAT-C and combined conditions only)
Description
Average number of total minutes practiced
Time Frame
Post-Assessment (8-10 weeks)
Title
Acceptability
Description
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
Time Frame
Post-Assessment (8-10 weeks)
Secondary Outcome Measure Information:
Title
ADHD Symptoms
Description
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
Time Frame
Post-Assessment (8-10 weeks)
Title
Total Problems
Description
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
Time Frame
Post-Assessment (8-10 weeks)
Title
Externalizing Problems
Description
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
Time Frame
Post-Assessment (8-10 weeks)
Title
Attention
Description
Pre-assessment to post-assessment difference on Flanker Task performance, as assessed by accuracy
Time Frame
Post-Assessment (8-10 weeks)
Title
Executive Function
Description
Pre-assessment to post-assessment difference on Hearts and Flowers Task, as assessed by accuracy
Time Frame
Post-Assessment (8-10 weeks)
Title
Working Memory
Description
Pre-assessment to post-assessment difference in performance on the List Sorting Working Memory Task, as assessed by accuracy
Time Frame
Post-Assessment (8-10 weeks)
Title
Mindfulness
Description
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
Time Frame
Post-Assessment (8-10 weeks)
Title
Overall Improvement
Description
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
Time Frame
Post-Assessment (8-10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David C Saunders, MD, PhD
Phone
9144096807
Email
david.saunders@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hedy Kober, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical & Affective Neuroscience Lab
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Italia Hanik, BS
Phone
814-525-5985
Email
italia.hanik@yale.edu
First Name & Middle Initial & Last Name & Degree
Hedy Kober, Ph.D.
First Name & Middle Initial & Last Name & Degree
James Leckman, MD PhD
First Name & Middle Initial & Last Name & Degree
David Saunders, MD PhD
First Name & Middle Initial & Last Name & Degree
Lawrece Vitulano, PhD

12. IPD Sharing Statement

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Mindfulness-Based ADHD Treatment for Children: a Feasibility Study

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