跳至主要内容
临床试验/NCT01348893
NCT01348893已完成不适用

Evaluation of Yoga During School as a Behavioral Prevention Program for Adolescent Health

Brigham and Women's Hospital6 个研究点 分布在 1 个国家目标入组 1,693 人开始时间: 2008年8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
1,693
试验地点
6
主要终点
Change in self-reported negative affect and positive affect measured by the 30-item Positive and Negative Affect Schedule for Children (PANAS-C)

研究概览

简要总结

The purpose of this preliminary study is to evaluate the effects of a yoga-based program on high school students' psychological health. Results will be used to generate specific hypotheses of how yoga may improve adolescent mental health.

详细描述

Specific Aims:

  1. To evaluate the hypothesis that 12 weeks of yoga during physical education will be acceptable by and feasible with high school students. To test Specific Aim 1, outcomes assessed at both Monument Mountain Regional High School and Waltham High School include: feasibility and acceptance.
  2. To evaluate the hypothesis that yoga will improve self-and parent-reported psychosocial well-being including affect, mood, stress and anxiety in high school students, relative to control students taking regular physical education. To test Specific Aim 2, both primary outcomes (affect and mood) will be assessed at both schools. Additional psychosocial well-being outcomes assessed at Monument Mountain Regional High School include: life purpose/satisfaction and self-confidence during stress; self-esteem; parent-reported psychological difficulties; perceived stress; and sleep quality. Additional psychosocial well-being outcomes assessed at Waltham High School include: self-esteem; parent-reported psychological difficulties; and sleep quality.
  3. To evaluate the hypothesis that yoga will improve self- and parent-reported self-regulatory skills including resilience, mindfulness, emotion regulation, anger expression, self-esteem and self-confidence relative to physical education controls. Self-regulation outcomes assessed at Monument Mountain Regional High School include: resilience; mindfulness; emotion regulation; control of anger expression; bullying; health behaviors; substance use risk factors; and attention. Self-regulation outcomes assessed at Waltham High School include: resilience; mindfulness; emotion regulation; control of anger expression; substance use risk factors; and attention.

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
14 Years 至 18 Years(Child, Adult)
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

High school 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

干预措施: Yoga (Behavioral)

结局指标

主要结局

Change in self-reported negative affect and positive affect measured by the 30-item Positive and Negative Affect Schedule for Children (PANAS-C)

时间窗: Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 1 week post-intervention

Change in self-reported mood as measured by: the 30-item Profile of Mood States Short Form (POMS-SF, total and 6 sub-scales), or the 24-item Brunel University Mood Scale (BRUMS, total and 6 sub-scales)

时间窗: Baseline; 1 week post-intervention

次要结局

  • Change in self-reported self-esteem as measured by the 10-item Rosenberg Self-Esteem Scale (RSES)(Baseline, 1 week post-intervention)
  • Change in self-reported anger expression and control as measured by part 3 of the 35-item State-Trait Anger Expression Inventory (STAXI2-C/A)(Baseline, 1 week post-intervention)
  • Change in self-reported substance use risk factors as measured by the 45-item UPPS Impulsive Behavior Scale (UPPS), or the 10-item Brief Sensation Seeking Scale with Slater's Addition (BSSS+S2)(Baseline, 1 week post-intervention)
  • Change in self-reported resilience (ability to adapt) as measured by the 25-item Resilience Scale (RS)(Baseline, 1 week post-intervention)
  • Change in self-reported life purpose/satisfaction and self-confidence during stress, as measured by the 32-item Inventory of Positive Psychological Attitudes (IPPA)(Baseline, 1 week post-intervention)
  • Feasibility and acceptance of the yoga program as measured by: student and parent forms of the 8-item Yoga Evaluation Questionnaire (YEQ), and 30-minute one-on-one qualitative interviews with students(1 week post-intervention)
  • Change in parent-reported psychological difficulties (total plus 5 sub-scales) as measured by the 25-item Strength and Difficulties Questionnaire (SDQ), parent/teacher form(Baseline, 1 week post-intervention)
  • Change in self-reported stress levels as measured by the 10-item Perceived Stress Scale (PSS)(Baseline, 1 week post-intervention)
  • Change in self-reported bullying and victimization by bullying as measured by the 12-item Peer Relations Questionnaire (PRQ)(Baseline, 1 week post-intervention)
  • Change in self-reported sensation seeking tendencies as measured by the 12 item Brief Sensation Seeking Scale and Slater's Addition (BSSS+SS2).(Baseline, 1 week post-intervention)
  • Change in self-reported mindfulness as measured by the 25-item Child Acceptance and Mindfulness Measure (CAMM)(Baseline, 1 week post-intervention)
  • Change in self-reported emotion regulation as measured by the 10-item Emotion Regulation Questionnaire (ERQ, 2 subscales), or the 36-item Difficulties in Emotion Regulation (DERS, 6 sub-scales)(Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 1 week post-intervention)
  • Change in self-reported sleep as measured by the 19-item Pittsburgh Sleep Quality Index (PSQI) or the 3-item Adolescent Sleep Quality (ASQ) scale(Baseline, 1 week post-intervention)
  • Change in self-reported physical activity and eating habits as measured by the 8-item Health Behaviors Survey (HBS)(Baseline, 1 week post-intervention)
  • Change in attention as measured by: self-report using the 9-item inattention sub-scale of the ADHD Self-Report Scale (ASRS), and a 20-minute O-SPAN task for working memory capacity(Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 1 week post-intervention)
  • Change in self-reported stress levels as measured by the 7-Item subscale of the Depression Anxiety Stress Scale (DASS)(Baseline, 1 week post-intervention)
  • Change in self-reported sadness levels as measured by the 3-Item subscale of the Sadness Management Scale (SMS)(Baseline, 1 week 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 (6)

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