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Evaluation of a Yoga Program in Schools

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01348893
First Posted: May 6, 2011
Last Update Posted: February 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kripalu Center for Yoga and Health
Information provided by (Responsible Party):
Sat Bir Khalsa, PhD, Brigham and Women's Hospital
April 29, 2010
May 6, 2011
February 15, 2016
August 2008
June 2016   (Final data collection date for primary outcome measure)
  • Change in self-reported negative affect and positive affect measured by the 30-item Positive and Negative Affect Schedule for Children (PANAS-C) [ Time Frame: 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) [ Time Frame: Baseline; 1 week post-intervention ]
Same as current
Complete list of historical versions of study NCT01348893 on ClinicalTrials.gov Archive Site
  • Change in self-reported resilience (ability to adapt) as measured by the 25-item Resilience Scale (RS) [ Time Frame: 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) [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported mindfulness as measured by the 25-item Child Acceptance and Mindfulness Measure (CAMM) [ Time Frame: 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) [ Time Frame: Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 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) [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported self-esteem as measured by the 10-item Rosenberg Self-Esteem Scale (RSES) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported stress levels as measured by the 10-item Perceived Stress Scale (PSS) [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported bullying and victimization by bullying as measured by the 12-item Peer Relations Questionnaire (PRQ) [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported physical activity and eating habits as measured by the 8-item Health Behaviors Survey (HBS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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). [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported sadness levels as measured by the 3-Item subscale of the Sadness Management Scale (SMS) [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported resilience (ability to adapt) as measured by the 25-item Resilience Scale (RS) [ Time Frame: 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) [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported mindfulness as measured by the 25-item Child Acceptance and Mindfulness Measure (CAMM) [ Time Frame: 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) [ Time Frame: Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 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) [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported self-esteem as measured by the 10-item Rosenberg Self-Esteem Scale (RSES) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported stress levels as measured by the 10-item Perceived Stress Scale (PSS) [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported sleep as measured by the 19-item Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported bullying and victimization by bullying as measured by the 12-item Peer Relations Questionnaire (PRQ) [ Time Frame: Baseline, 1 week post-intervention ]
  • Change in self-reported physical activity and eating habits as measured by the 8-item Health Behaviors Survey (HBS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 1 week post-intervention ]
Not Provided
Not Provided
 
Evaluation of a Yoga Program in Schools
Evaluation of Yoga During School as a Behavioral Prevention Program for Adolescent Health
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Adolescent Development
Behavioral: Yoga
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.
Other Name: Kripalu Yoga In The Schools
  • No Intervention: Physical education as usual
    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.
  • Experimental: Yoga during physical education
    Intervention: Behavioral: Yoga

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1800
June 2016
June 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Registered for physical education class
Sexes Eligible for Study: All
14 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01348893
2007P002600A
No
Not Provided
Not Provided
Sat Bir Khalsa, PhD, Brigham and Women's Hospital
Brigham and Women's Hospital
Kripalu Center for Yoga and Health
Principal Investigator: Sat Bir S Khalsa, PhD Brigham and Women's Hospital
Brigham and Women's Hospital
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP