Mindfulness-Based ADHD Treatment for Children: a Feasibility Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mindfulness-Based ADHD Treatment for Children
干预措施: Mindfulness-Based ADHD Treatment for Children (Behavioral)
Medication
干预措施: Goal-Standard Medication (Treatment as Usual) (Biological)
Combined (MBAT-C + medication)
干预措施: Mindfulness-Based ADHD Treatment for Children (Behavioral)
Combined (MBAT-C + medication)
干预措施: Goal-Standard Medication (Treatment as Usual) (Biological)
结局指标
主要结局
Recruitment
时间窗: Completion of study (up to 30 months)
Average time from screening to enrollment
Participation - Student Rated (for MBAT-C and combined conditions only)
时间窗: 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
Randomization
时间窗: Completion of study (up to 30 months)
Percent of enrolled who attend at least one session
Attendance (MBAT-C Condition)
时间窗: Post-Assessment (8-10 weeks)
Average number of minutes attended
Attendance (Combined Condition)
时间窗: Post-Assessment (8-10 weeks)
Average number of minutes of MBAT-C attended
Medication Adherence (for medication and combined conditions only)
时间窗: Post-Assessment (8-10 weeks)
Average percent of prescribed doses taken
Retention
时间窗: Post-Assessment (8-10 weeks)
Percent of enrolled who attend \>60% of study sessions
Attendance (Medication Condition)
时间窗: Post-Assessment (8-10 weeks)
Average percent of scheduled medication visits attended
Acceptability
时间窗: 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
Homework Completion (for MBAT-C and combined conditions only)
时间窗: Post-Assessment (8-10 weeks)
Average number of total minutes practiced
Participation - Teacher Rated (for MBAT-C and combined conditions only)
时间窗: 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
次要结局
- ADHD Symptoms(Post-Assessment (8-10 weeks))
- Total Problems(Post-Assessment (8-10 weeks))
- Executive Function(Post-Assessment (8-10 weeks))
- Externalizing Problems(Post-Assessment (8-10 weeks))
- Overall Improvement(Post-Assessment (8-10 weeks))
- Attention(Post-Assessment (8-10 weeks))
- Working Memory(Post-Assessment (8-10 weeks))
- Mindfulness(Post-Assessment (8-10 weeks))