Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
"Attention Deficit Hyperactivity Disorder"
Type
Interventional
Phase
Early Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 7 years and 13 years
Gender
Both males and females

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 treat...

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.

Tracking Information

NCT #
NCT04737512
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Hedy Kober, PhD Yale University