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临床试验/NCT05537961
NCT05537961已完成不适用

Impact of Mindfulness Training on Adolescent Well-Being and Behavior

University of Utah2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Youth Risk Behavior Surveillance System: Substance use

研究概览

简要总结

There is a broad consensus that preventing or delaying initiation of adolescent alcohol, tobacco, and other drug (ATOD) use can substantially improve both short- and long-term adolescent health. Despite the existence of effective prevention programs, adolescent ATOD use continues to be a substantial issue. Continued research on preventive interventions is needed. School-based mindfulness-based interventions (MBIs) have been shown to be feasible and effective at improving adolescent psychological well-being. Evidence from both quasi-experimental studies and randomized controlled trials suggests that incorporating MBIs into school-settings can lower levels of anxiety, depression, and stress, while improving capacity for emotional regulation. Greater mindfulness also been linked to reduced adolescent ATOD use via observational studies. There are strong theoretical reasons to believe that MBIs delivered in school settings can prevent or reduce ATOD use among youth. In particular, MBIs have been shown to improve psychological well-being among youth via multiple mechanisms also relevant for adolescent ATOD use. These mechanisms include enhanced attentional control, negative emotion regulation, promotion of positive emotion generation, and increased feelings of connectedness. Despite these connections, school-based MBIs are yet to demonstrate the ability to prevent or reduce adolescent ATOD use.

The current study will examine psychological well-being and ATOD use among approximately 80 participants in a quasi-experimental, school-based MBI. In early 2022, approximately 40 high school seniors were provided with one semester of a weekly, classroom-based MBI embedded into their Social Studies curriculum; approximately 40 high school seniors participated in the standard curriculum. The intervention group was provided with an adaptation of Mindfulness-Oriented Recovery Enhancement (MORE). MORE is an evidence-based therapeutic program that integrates mindfulness, cognitive-behavioral therapy, and positive psychology to treat addiction and enhance well-being. MORE has been shown to produce therapeutic benefits in the treatment of alcohol, tobacco, and other drug addiction in adult populations, but is yet to be tested as a preventive intervention for youth. Follow up data collection is planned for spring 2023 to assess psychological well-being, ATOD use, and proposed therapeutic mechanisms pre-intervention, post-intervention, and at 9-month follow up.

详细描述

There is a broad consensus that preventing or delaying initiation of adolescent alcohol, tobacco, and other drug (ATOD) use can substantially improve both short- and long-term adolescent health. Despite the existence of effective prevention programs, adolescent ATOD use continues to be a substantial issue. Continued research on preventive interventions is needed. School-based mindfulness-based interventions (MBIs) have been shown to be feasible and effective at improving adolescent psychological well-being. Evidence from both quasi-experimental studies and randomized controlled trials suggests that incorporating MBIs into school-settings can lower levels of anxiety, depression, and stress, while improving capacity for emotional regulation. Greater mindfulness also been linked to reduced adolescent ATOD use via observational studies. There are strong theoretical reasons to believe that MBIs delivered in school settings can prevent or reduce ATOD use among youth. In particular, MBIs have been shown to improve psychological well-being among youth via multiple mechanisms also relevant for adolescent ATOD use. These mechanisms include enhanced attentional control, negative emotion regulation, promotion of positive emotion generation, and increased feelings of connectedness. Despite these connections, school-based MBIs are yet to demonstrate the ability to prevent or reduce adolescent ATOD use.

The current study will examine psychological well-being and ATOD use among approximately 80 participants in a quasi-experimental, school-based MBI. In early 2022, approximately 40 high school seniors were provided with one semester of a weekly, classroom-based MBI embedded into their Social Studies curriculum; approximately 40 high school seniors participated in the standard curriculum. The intervention group was provided with an adaptation of Mindfulness-Oriented Recovery Enhancement (MORE). MORE is an evidence-based therapeutic program that integrates mindfulness, cognitive-behavioral therapy, and positive psychology to treat addiction and enhance well-being. MORE has been shown to produce therapeutic benefits in the treatment of alcohol, tobacco, and other drug addiction in adult populations, but is yet to be tested as a preventive intervention for youth. Follow up data collection is planned for spring 2023 to assess psychological well-being, ATOD use, and proposed therapeutic mechanisms pre-intervention, post-intervention, and at 9-month follow up. Trajectories of change will be assessed to test the following three aims.

Aim 1 is to examine the impact of MORE on changes in students' psychological well-being (i.e., anxiety, depression, stress) and ATOD use relative to a standard curriculum. The investigators hypothesize that MORE will improve psychological well-being and reduce ATOD use, relative to the standard curriculum.

Aim 2 is to examine the impact of MORE on changes in students' attentional control (i.e., mindfulness), negative emotion regulation (i.e., positive reappraisal), positive emotion generation (i.e., savoring), and feelings of connectedness (i.e., self-transcendence) relative to a standard curriculum. The investigators hypothesize that MORE will improve attentional control, negative emotion regulation, and positive emotion generation, as well as increasing feelings of connectedness, relative to a standard curriculum.

Aim 3 is to examine the extent to which MORE encourages improved psychological well-being and reduced ATOD use via the therapeutic mechanisms identified in Aim 2 (attentional control, negative emotion regulation, positive emotion generation, and feelings of connectedness). The investigators hypothesize that the relationship between MORE and positive outcomes will be mediated by the proposed therapeutic mechanisms.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled as a high school senior in two specific classes at Judge Memorial High School during Spring 2022

排除标准

  • Not enrolled as a high school senior in two specific classes at Judge Memorial High School during Spring 2022

结局指标

主要结局

Youth Risk Behavior Surveillance System: Substance use

时间窗: change in each measure across 9 months

alcohol, tobacco, and other drug use as measured by the Youth Risk Behavior Surveillance System. Items are measured as any use on both lifetime and past 30 days.

Pediatric Patient Reported Outcomes Measurement Information System (PROMIS)

时间窗: change in each measure across 9 months

positive affect, life satisfaction, meaning and purpose, anxiety, depressive symptoms as measured by the pediatric PROMIS. For each scale, higher scores indicate higher levels of the name of the scale. Items on each scale are summed and T scores with a mean of 50 and standard deviation of 10 are calculated.

Toronto Mindfulness Scale

时间窗: change in each measure across 9 months

Mindfulness as measured by the Toronto Mindfulness Scale. Higher scores indicate higher degree of state mindfulness. Scores range from 0 to 24 on the curiosity subscale and from 0 to 28 on the decentering subscale.

Youth Risk Behavior Surveillance System: Suicide ideation

时间窗: change in each measure across 9 months

suicide ideation and attempts as measured by the Youth Risk Behavior Surveillance System. Suicide ideation is measured as any ideation in the past 12 months and attempts are measured as the count of attempts in the past 12 months.

Child Acceptance and Mindfulness Measure

时间窗: change in each measure across 9 months

Mindfulness as measured by the child acceptance and mindfulness measure (CAMM). The CAMM is scored from 0 to 40 with higher scores indicating higher levels of mindfulness

Nondual Awareness Dimensional Assessment

时间窗: change in each measure across 9 months

Transcendental experiences as measured by the Nondual Awareness Dimensional Assessment (NADA). Higher scores indicate greater nondual awareness trait scored from 0 to 12 and nondual awareness states scores from 0 to 40

Cognitive Emotion Regulation Questionnaire

时间窗: change in each measure across 9 months

Positive reappraisal as measured by the Cognitive Emotion Regulation Questionnaire (CERQ). The CERQ is scored from 1 to 7 with higher scores indicating higher levels of emotion regulation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Cambron

Assistant Professor

University of Utah

研究点 (2)

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