Mindfulness-Based ADHD Treatment for Children: a Feasibility Study

NCT ID: NCT04737512

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2024-10-29

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness-Based ADHD Treatment for Children

Group Type: EXPERIMENTAL

Mindfulness-Based ADHD Treatment for Children

Intervention Type: 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.

Medication

Group Type: ACTIVE_COMPARATOR

Goal-Standard Medication (Treatment as Usual)

Intervention Type: 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)

Group Type: ACTIVE_COMPARATOR

Mindfulness-Based ADHD Treatment for Children

Intervention Type: 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)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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:

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.

Intervention Type: BIOLOGICAL

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

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hedy Kober, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Clinical & Affective Neuroscience Lab

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1R34AT009887-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000020705

Identifier Type: -

Identifier Source: org_study_id