- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01348893
Evaluation of a Yoga Program in Schools
March 18, 2019 updated by: Sat Bir Khalsa, PhD, Brigham and Women's Hospital
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.
Study Overview
Detailed Description
Specific Aims:
- 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.
- 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.
- 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.
Study Type
Interventional
Enrollment (Actual)
1693
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Boston Latin Public School
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Great Barrington, Massachusetts, United States, 01230
- Monument Mountain Regional High School
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Waltham, Massachusetts, United States, 02452
- Waltham Senior High School
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Registered for physical education class
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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|
Experimental: Yoga during physical education
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Baseline; 1 week post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in self-reported resilience (ability to adapt) as measured by the 25-item Resilience Scale (RS)
Time Frame: Baseline, 1 week post-intervention
|
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
|
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
|
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
|
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
|
Baseline, 1 week post-intervention
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Change in self-reported self-esteem as measured by the 10-item Rosenberg Self-Esteem Scale (RSES)
Time Frame: Baseline, 1 week post-intervention
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Baseline, 1 week post-intervention
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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
|
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
|
Baseline, 1 week post-intervention
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Change in self-reported stress levels as measured by the 10-item Perceived Stress Scale (PSS)
Time Frame: Baseline, 1 week post-intervention
|
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
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Baseline, 1 week post-intervention
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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
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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
|
Baseline, 1 week post-intervention
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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
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Baseline, 1 week post-intervention
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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
|
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
|
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
|
Baseline, 1 week post-intervention
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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
|
Baseline, 1 week post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Noggle JJ, Steiner NJ, Minami T, Khalsa SB. Benefits of yoga for psychosocial well-being in a US high school curriculum: a preliminary randomized controlled trial. J Dev Behav Pediatr. 2012 Apr;33(3):193-201. doi: 10.1097/DBP.0b013e31824afdc4.
- Khalsa SR, McCarthy KS, Sharpless BA, Barrett MS, Barber JP. Beliefs about the causes of depression and treatment preferences. J Clin Psychol. 2011 Jun;67(6):539-49. doi: 10.1002/jclp.20785. Epub 2011 Mar 1.
- Conboy LA, Noggle JJ, Frey JL, Kudesia RS, Khalsa SB. Qualitative evaluation of a high school yoga program: feasibility and perceived benefits. Explore (NY). 2013 May-Jun;9(3):171-80. doi: 10.1016/j.explore.2013.02.001.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
April 29, 2010
First Submitted That Met QC Criteria
May 5, 2011
First Posted (Estimate)
May 6, 2011
Study Record Updates
Last Update Posted (Actual)
March 19, 2019
Last Update Submitted That Met QC Criteria
March 18, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2007P002600A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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