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
- 45
- 主要终点
- Teacher 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 main questions it aims to answer are:
- Is MINDS-UP feasible and what is its preliminary efficacy?
- Are MRI protocol and procedures feasible?
An additional exploratory question is:
Are there neural and psychopathological mechanisms through which MINDS-UP might work?
Researchers will compare Sport - Prevention Plus Wellness (PPW) (an evidence based substance use prevention program) to Sport - Prevention Plus Wellness + MINDS-UP to examine the preliminary efficacy of MINDS-UP.
Participants will
- take assessment #1
- have 2 MRIs and take MINDS-UP, just take MINDS-UP or have a delayed start
- take assessment #2
- take PPW, a single remote and research assistant-delivered 45-minute session
- take assessment #3
- take assessment #4
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]
- •Access to a smart phone, tablet, or computer with Wi-Fi
- •English-speaking
排除标准
- •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.
- •Youth is actively involved in another Boricua Youth Study (BYS)
- •Youth's sibling is or has previously been enrolled in MINDS-UP.
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 remote-delivered 45-minute session by a research assistant (RA) trained in PPW 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)
MINDS-UP with MRI + PPW
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. Half of those randomized to receive MINDS-UP + PPW (n=10) will receive functional and structural MRI before and after MINDS-UP to evaluate feasibility and acceptability of our MRI procedures and study design. Participants randomized to MINDS-UP with MRI arm will also complete PPW.
干预措施: MINDS-UP (Behavioral)
MINDS-UP with MRI + PPW
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. Half of those randomized to receive MINDS-UP + PPW (n=10) will receive functional and structural MRI before and after MINDS-UP to evaluate feasibility and acceptability of our MRI procedures and study design. Participants randomized to MINDS-UP with MRI arm will also complete PPW.
干预措施: Prevention Plus Wellness (Behavioral)
MINDS-UP with MRI + PPW
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. Half of those randomized to receive MINDS-UP + PPW (n=10) will receive functional and structural MRI before and after MINDS-UP to evaluate feasibility and acceptability of our MRI procedures and study design. Participants randomized to MINDS-UP with MRI arm will also complete PPW.
干预措施: fMRI (Diagnostic Test)
MINDS-UP without MRI + PPW
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 without MRI arm will also complete PPW.
干预措施: MINDS-UP (Behavioral)
MINDS-UP without MRI + PPW
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 without MRI arm will also complete PPW.
干预措施: Prevention Plus Wellness (Behavioral)
结局指标
主要结局
Teacher Rated Participation
时间窗: Completion of Study (up to 36 months)
Research Assessment Package for Schools - Teacher Rated
Homework Completion
时间窗: Completion of Study (up to 36 months)
Percentage of assigned homeworks that were completed by the participant.
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.
Participation (student)
时间窗: Completion of Study (up to 36 months)
Research Assessment Package for Schools - Student Engagement
次要结局
- 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)
- ADHD Symptoms(4-6 weeks, 6 months, and 12 months)
研究者
David Saunders, MD PhD
Assistant Prof of Psychiatry
New York State Psychiatric Institute