跳至主要内容
临床试验/NCT01821950
NCT01821950已完成不适用

Evaluation of Yoga for Substance Use Risk Factors in a School Setting

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2013年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
211
试验地点
2
主要终点
Change in self-reported impulsive behavior as measured by the 59-item Urgency, Premeditation, Perseverance, and Sensation Seeking Plus (UPPS-P) Impulsive Behavior scale (4 sub-scales)

研究概览

简要总结

This study will evaluate the efficacy of yoga taught during school to positively influence risk and protective factors of substance use and the initiation and severity of substance use. The study hypothesis is that, compared to a control group participating in regular physical education classes, subjects who participate in 32 yoga sessions across an academic year will improve in negative internalizing behaviors and self-regulatory skills that are known risk and protective factors for substance use. This study will also test the hypothesis that the yoga intervention will reduce both severity of substance use and the degree of substance use initiation.

详细描述

The long-term, programmatic goal of this research is to advance prevention of addictive behaviors especially substance use in normal adolescent psychological development. The overall goal of this proposal is to pilot test a novel, preventive intervention for adolescent substance use. More specifically, it will evaluate the efficacy of yoga taught during school to positively influence risk and protective factors of substance use and the initiation and severity of substance use.

This study involves a group randomized, controlled trial of yoga compared to physical education-as-usual for one school year, with a 6-month and 1-year follow-up, in order to accomplish the following specific aims:

Specific Aim 1 - To evaluate the efficacy of a school-based yoga program for reducing negative internalizing behaviors (negative mood, perceived stress, impulsivity) which are risk factors for adolescent substance use.

Specific Aim 2 - To evaluate the efficacy of this yoga program for promoting self-regulatory skills as protective factors against substance use in adolescence.

Specific Aim 3 - To conduct a preliminary evaluation of the efficacy of this yoga program for reducing substance use initiation and severity of use.

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
11 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Registered for physical education class

排除标准

  • 未提供

研究组 & 干预措施

Physical education as usual

No Intervention

Physical education curriculum established by the school, including competitive sports, aerobic and anaerobic activities, balance and coordination skills. Yoga is not a component of the curriculum.

Yoga during physical education

Experimental

12 to 16 weeks of group yoga classes (approximately 32 classes per student), 30-45 minutes per class, 2-3 times per week, during physical education class. Yoga program includes physical postures and movement, breathing exercises, partner/group games, deep relaxation and meditative techniques.

干预措施: Yoga during physical education (Behavioral)

结局指标

主要结局

Change in self-reported impulsive behavior as measured by the 59-item Urgency, Premeditation, Perseverance, and Sensation Seeking Plus (UPPS-P) Impulsive Behavior scale (4 sub-scales)

时间窗: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention

The Urgency, Premeditation, Perseverance, and Sensation Seeking Plus (UPPS-P) Impulsive Behavior scale is a 59-item self-report scale developed by Whiteside and Lynam to measure the multi-dimensional nature of impulsivity. Items are scored based on a four-point Likert-type scale as follows: 1) agree strongly, 2) agree somewhat, 3) disagree somewhat, and 4) disagree strongly. Factor analysis of eight other established scales that address impulsivity (in whole or part) revealed four factors that became the subscales in the UPPS-P: (lack of) Premeditation (11 items), Negative Urgency (11 items), Positive Urgency (14 items), Sensation Seeking (12 items), and (lack of) Perseverance (10 items). Internal consistency for these subscales showed alpha coefficients that ranged from 0.82 to 0.91.

Change in self-reported mood as measured by the 24-item Brunel University Mood Scale (BRUMS, total and 6 sub-scales)

时间窗: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention

The Brunel University Mood Scale (BRUMS) will be used to measure change in self-reported mood. The BRUMS is designed specifically for assessing mood in adolescents. It contains 24 adjectives that are all rated on a four-point scale to give a total mood score and scores for six subscales: tension, depression, anger, vigor, fatigue, and confusion. In a validation sample of nearly 2,000 British adolescents (12 to 18 years of age), multi-sample confirmatory factor analysis showed high factor validity. Criterion and construct validity were also acceptable. Furthermore, BRUMS is sensitive to short-term changes. More recently, the BRUMS has been successfully used in a large sample of American adolescents. Negative affective states, such as mood, are clearly linked to substance use trajectories.

Change in self-reported stress levels as measured by the 10-item Perceived Stress Scale (PSS)

时间窗: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention

The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the degree to which events are appraised as stressful during the last month. Construct and convergent validity is adequate, since it is moderately correlated with other measures of stress and self-reported health status. The 10 items in this scale were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. It is psychometrically sound based on epidemiological sampling that evaluated reliability and validity. Furthermore, the PSS has been administered to mid-adolescents (8th and 9th graders) with good internal consistency. Psychological stress has been associated with substance use in studies of adolescents and college students.

次要结局

  • Change in self-reported affective lability as measured by the Affective Lability Scale (originally 54 items, adapted to 10 items)(Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention)
  • Change in self-reported soothability, planfulness, and distractibility as measured by the Kendall-Wilcox Self-Control Schedule (3 sub-scales).(Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention)
  • Change in self-reported anger control and anger rumination as measured by the Children's Anger Management Scale (2 sub-scales)(Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention)
  • Change in self-reported impulsiveness as measured by the Eysenck Impulsiveness Questionnaire (EIQ) (1 subscale)(Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention)
  • Change in self-reported sadness control and sadness rumination as measured by the Children's Sadness Management Scale (CSMS) (2 sub-scales)(Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention)
  • Change in self-reported anger coping, problem solving, situation redefinition, impatience, and self-criticism as measured by the Wills Coping Inventory (5 sub-scales)(Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention)
  • Change in self-reported positive self-reinforcement as measured by the 8-item Heiby Self-Reinforcement Inventory(Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention)
  • Change in self-reported substance use as measured by the Youth Risk Behavior Survey (YRBS) (4 subscales)(Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention)
  • Change in self-reported present and future time perspective as measured by the Zimbardo Time Perspective Inventory (2 sub-scales)(Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention)
  • Change in self-reported substance use willingness as measured by the 13-item Substance Use Willingness Questionnaire(Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention)

研究者

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

Sat Bir Khalsa, PhD

Assistant Professor of Medicine

Brigham and Women's Hospital

研究点 (2)

Loading locations...

相似试验

Evaluation of Yoga for Substance Use Risk Factors in... | 临床试验