Efficacy and Neurobiological Mechanisms of a Parenting-focused Mindfulness Intervention to Prevent Adolescent Substance Use
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 269
- 试验地点
- 2
- 主要终点
- Adolescent psychological symptoms
研究概览
简要总结
This study will conduct a large Randomized Controlled Trial to test effects of a parenting mindfully (PM) intervention versus a parent education (PE) intervention for highly stressed parents of adolescents.
详细描述
Parents of early adolescents who report experiencing stress will be randomly assigned to receive the 8 week PM or PE intervention. Before, during, and after the interventions, and at 6 month, 1 year, and 2 year follow-ups (into middle adolescence), the researchers will collect questionnaire, interview, and biological measures of parent stress, parenting, and adolescent substance use and psychological symptoms. At pre- and post-intervention, observed parenting and stress reactivity will be measured in a parent-adolescent interaction task. Some mothers will also complete fMRI sessions at pre- and post- examining emotion-related neurobiological mechanisms.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Study Inclusion/
排除标准
- •Inclusion Criteria:
- •Family with adolescent between 12-14 years;
- •High stress levels for at least one primary caregiver (referred to as "parents" throughout the application, but not required to be biological parents) on stress screener;
- •Adequate English proficiency to complete questionnaires for adolescent and at least one parent (because several of our questionnaires have not been validated for use in other languages)
- •Exclusion Criteria:
- •Diagnosis of intellectual disability for adolescent or psychosis for adolescent;
- •Current active suicidality that is untreated for parent or adolescent (We will refer participants with active suicidality for inpatient treatment. They will be eligible to participate in the study once stabilized),
- •Current SUDs that are untreated for parent except Tobacco Use Disorder (because participants must to be able to refrain from substances except nicotine/tobacco during the PAIT lab session day safely without withdrawal symptoms). We will refer parents with active SUDs to treatment. They will be eligible to participate in the study once stabilized and in treatment.
- •Lifetime SUD diagnosis for adolescent because an aim of the study is SUD prevention.
- •Note: We are recruiting for about 130 of the primary caregiver parents to be eligible in and interested in completing functional magnetic resonance imaging (fMRI) scans are pre and post-intervention. If we do not meet this number, we will restrict recruitment to those families with one parent who is interested in and eligible for fMRI.
研究组 & 干预措施
Parent Education (PE) Intervention
PE is a group based 8 week educational intervention for parents that teaches parents about adolescent development.
干预措施: Parenting Mindfully Intervention (Behavioral)
Parenting Mindfully (PM) Intervention
PM is an group based 8 week mindfulness intervention for parents.
干预措施: Parenting Mindfully Intervention (Behavioral)
结局指标
主要结局
Adolescent psychological symptoms
时间窗: 2 years
youth self reported symptoms on the Youth Inventory and parent reported symptoms on the Child Symptom Inventory will be combined or, if needed, tested separately in analyses. To combine, we will first transform all measures into z-scores (standardized scores) and then will combine them (either through composite scoring or through SEM latent variables).
Adolescent substance use
时间窗: 2 years
frequency and amount of substance use This will be based on combining (in a composite score) information from the Youth Risk Behavior Survey, Urine and Breath Screens, and the Timeline Follow Back Interview to determine frequency and amount of use. To combine, we will first transform all measures into z-scores (standardized scores) and then will combine them (either through composite scoring or through SEM latent variables).
次要结局
未报告次要终点
研究者
Tara M. Chaplin, Ph.D.
Associate Professor of Psychology
George Mason University