Clinical trial NCT04737512: Mindfulness-Based ADHD Treatment for Children: a Feasibility Study
Official title: Mindfulness-Based ADHD Treatment for Children: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
mindfulness
meditation
children
feasibility
acceptability
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-02-04
Enrollment: 68
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Recruitment
timeFrame: Completion of study (up to 30 months)
measure: Recruitment
timeFrame: Completion of study (up to 30 months)
measure: Randomization
timeFrame: Completion of study (up to 30 months)
measure: Randomization
timeFrame: Completion of study (up to 30 months)
measure: Attendance (MBAT-C Condition)
timeFrame: Post-Assessment (8-10 weeks)
measure: Attendance (Medication Condition)
timeFrame: Post-Assessment (8-10 weeks)
measure: Attendance (Combined Condition)
timeFrame: Post-Assessment (8-10 weeks)
measure: Attendance (Combined Condition)
timeFrame: Post-Assessment (8-10 weeks)
measure: Medication Adherence (for medication and combined conditions only)
timeFrame: Post-Assessment (8-10 weeks)
measure: Retention
timeFrame: Post-Assessment (8-10 weeks)
measure: Participation - Student Rated (for MBAT-C and combined conditions only)
timeFrame: Post-Assessment (8-10 weeks)
measure: Participation - Teacher Rated (for MBAT-C and combined conditions only)
timeFrame: Post-Assessment (8-10 weeks)
measure: Homework Completion (for MBAT-C and combined conditions only)
timeFrame: Post-Assessment (8-10 weeks)
measure: Homework Completion (for MBAT-C and combined conditions only)
timeFrame: Post-Assessment (8-10 weeks)
measure: Acceptability
timeFrame: Post-Assessment (8-10 weeks)
Secondary outcomes:
measure: ADHD Symptoms
timeFrame: Post-Assessment (8-10 weeks)
measure: Total Problems
timeFrame: Post-Assessment (8-10 weeks)
measure: Externalizing Problems
timeFrame: Post-Assessment (8-10 weeks)
measure: Attention
timeFrame: Post-Assessment (8-10 weeks)
measure: Executive Function
timeFrame: Post-Assessment (8-10 weeks)
measure: Working Memory
timeFrame: Post-Assessment (8-10 weeks)
measure: Mindfulness
timeFrame: Post-Assessment (8-10 weeks)
measure: Overall Improvement
timeFrame: Post-Assessment (8-10 weeks)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Clinical & Affective Neuroscience Lab
state: Connecticut
Study officials:
affiliation: Yale University
name: Hedy Kober, PhD
role: PRINCIPAL_INVESTIGATOR
References: