Mindfulness-Based Substance Use Prevention (MINDS-UP): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Student-Rated Participation
研究概览
简要总结
The goal of this clinical trial is to test the feasibility, behavioral/neural mechanisms, and preliminary efficacy of "MINDfulness-based Substance Use Prevention Program," or "MINDS-UP", a novel substance use prevention meditation intervention for children and adolescents between the ages of 10 and 14. The aims of the study are:
Aim 1: Determine feasibility and acceptability of MINDS-UP as a preventive intervention via a) retention, b) attendance, c) teacher-rated participation, d) student-rated participation, e) homework completion, and f) acceptability.
Aim 2: Evaluate neuropsychological mechanisms (target engagement) of MINDS-UP.
Aim 3 (Exploratory): Assess preliminary efficacy of MINDS-UP on substance use initiation (SUI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Youth is ages 10-14 years on the day of screening [i.e., does not turn 15 before or on the day of screening]
- •Youth has access to a smartphone, tablet, or computer with Wi-Fi
- •Youth and parent are English-speaking
排除标准
- •1. The youth has been diagnosed with or received treatment for one of the following mental health problems: depression, bipolar disorder, schizophrenia, autism spectrum disorder, intellectual disability, or substance use disorder.
研究组 & 干预措施
Sport: Prevention Plus Wellness (PPW)
Sport: Prevention Plus Wellness (PPW) is a brief, evidence-based substance use prevention program for youth. PPW consists of a single self-administered 45-minute session that is interactive and intended for use by youth in the home setting. It involves screening youth to increase awareness of their current health behaviors; motivational enhancement for change; and establishing a behavior goal plan.
干预措施: Prevention Plus Wellness (Behavioral)
PPW + MINDS-UP
MINDS-UP consists of 4 x 60-minute sessions, once weekly over 4 weeks. MINDS-UP will be delivered to participants remotely, in a 1:1 setting, taught by the meditation teachers that will be hired and trained by Dr. Saunders. Additionally, participants will be provided audio files of 5-10-minute guided meditation practices, led by Dr. Saunders, as homework. Participants randomized to MINDS-UP will also complete PPW, a 45 minute, self-administered course.
干预措施: MINDS-UP (Behavioral)
PPW + MINDS-UP
MINDS-UP consists of 4 x 60-minute sessions, once weekly over 4 weeks. MINDS-UP will be delivered to participants remotely, in a 1:1 setting, taught by the meditation teachers that will be hired and trained by Dr. Saunders. Additionally, participants will be provided audio files of 5-10-minute guided meditation practices, led by Dr. Saunders, as homework. Participants randomized to MINDS-UP will also complete PPW, a 45 minute, self-administered course.
干预措施: Prevention Plus Wellness (Behavioral)
结局指标
主要结局
Student-Rated Participation
时间窗: Completion of Study (up to 36 months)
Research Assessment Package for Schools - Student Engagement
Teacher Rated Participation
时间窗: Completion of Study (up to 36 months)
Research Assessment Package for Schools - Teacher Rated
Acceptability
时间窗: Completion of Study (up to 36 months)
Acceptability of Intervention Measure
Retention
时间窗: Completion of Study (up to 36 months)
Percent of participants who completed all study procedures among those who were randomized
Attendance
时间窗: Completion of Study (up to 36 months)
Percent of scheduled sessions that were completed by the participant.
Homework Completion
时间窗: Completion of Study (up to 36 months)
Percentage of assigned homeworks that were completed by the participant.
Participation (student)
时间窗: Completion of Study (up to 36 months)
Research Assessment Package for Schools - Student Engagement
次要结局
- ADHD Symptoms(4-6 weeks, 6 months, and 12 months)
- Total Problems (parent-report)(4-8 weeks, 6 months, and 12 months)
- Suicidal Thoughts/Behaviors(4-6 weeks, 6 months, 12 months)
- Total Problems (adolescent report)(4-6 weeks, 6 months, 12 months)
- Perceived Tolerance of Use(baseline)
- Perceived Harm of Substance Use(baseline)
- Beliefs About Alcohol Effects(baseline)
- Beliefs About Smoking Effects(baseline)
- Beliefs About Cannabis Effects(baseline)
- Risk and Protective Factors(Baseline)
- MRI retention(Completion of Study (up to 36 months))
- Future MRI endorsement(Completion of Study (up to 36 months))
- Anxiety and Depression(4-6 weeks, 6 months, and 12 months)
- Mindfulness(4-6 weeks, 6 months, and 12 months)
- Externalizing Problems (parent-report)(4-6 weeks, 6 months, and 12 months)
- Externalizing Problems (self-report)(4-6 weeks, 6 months, and 12 months)
- Total Problems (self-report)(4-6 weeks, 6 months, and 12 months)
- Total Problems (parent-report)(4-6 weeks, 6 months, and 12 months)
- Cannabis Use(4-6 weeks, 6 months, and 12 months)
- Alcohol sipping(4-6 weeks, 6 months, and 12 months)
- Tobacco Use(4-6 weeks, 6 months, and 12 months)
研究者
David Saunders, MD PhD
Assistant Prof of Psychiatry
New York State Psychiatric Institute