Adolescent DevelopmentNCT01348893
Evaluation of a Yoga Program in Schools
A study testing Yoga in people with Adolescent Development, run by Brigham and Women's Hospital at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Development
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,693 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2008to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Registered for physical education class
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston Latin Public School
Boston, Massachusetts, 02115
Monument Mountain Regional High School
Great Barrington, Massachusetts, 01230
Waltham Senior High School
Waltham, Massachusetts, 02452
About this study
Official title: 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.
Read the 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.
- Conditions
- Adolescent Development
- Being tested
- Yoga
- Keywords
- Mental health, Education, Mind Body Therapies
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Also called Kripalu Yoga In The Schools
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported negative affect and positive affect measured by the 30-item Positive and Negative Affect Schedule for Children (PANAS-C)
Measured: 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)
Measured: Baseline; 1 week post-intervention
Secondary outcomes (17)
Change in self-reported resilience (ability to adapt) as measured by the 25-item Resilience Scale (RS)
Measured: 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)
Measured: Baseline, 1 week post-intervention
Change in self-reported mindfulness as measured by the 25-item Child Acceptance and Mindfulness Measure (CAMM)
Measured: 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)
Measured: 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)
Measured: Baseline, 1 week post-intervention
Change in self-reported self-esteem as measured by the 10-item Rosenberg Self-Esteem Scale (RSES)
Measured: 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
Measured: 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
Measured: Baseline, 1 week post-intervention
Change in self-reported stress levels as measured by the 10-item Perceived Stress Scale (PSS)
Measured: 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
Measured: Baseline, 1 week post-intervention
Change in self-reported bullying and victimization by bullying as measured by the 12-item Peer Relations Questionnaire (PRQ)
Measured: Baseline, 1 week post-intervention
Change in self-reported physical activity and eating habits as measured by the 8-item Health Behaviors Survey (HBS)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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).
Measured: Baseline, 1 week post-intervention
Change in self-reported sadness levels as measured by the 3-Item subscale of the Sadness Management Scale (SMS)
Measured: Baseline, 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startAug 2008
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adolescent DevelopmentStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kripalu Center for Yoga and Health
- Responsible party
- Principal investigator, Sat Bir Khalsa, PhD, Brigham and Women's Hospital
- Investigators
- Sat Bir S Khalsa, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348893
- Sponsor's protocol ID
- 2007P002600A
- Status last verified
- Mar 2019
- First submitted
- 29 Apr 2010
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22343481Khalsa 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.
PubMed 21365652Conboy 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.
PubMed 23643372
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Yoga During School as a Behavioral Prevention Program for Adolescent Health
- ClinicalTrials.gov ID
- NCT01348893
- Acronym / sponsor ID
- 2007P002600A
- Conditions
- Adolescent Development
- Keywords
- Mental health, Education, Mind Body Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,693 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Kripalu Center for Yoga and Health
- Study start
- Aug 2008
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Yoga |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Registered for physical education class
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaAlso: Kripalu Yoga In The Schools12 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. | Behavioural | Yoga during physical education |
Primary outcome
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
17 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Results publication: PubMed 22343481Noggle 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.
- Results publication: PubMed 21365652Khalsa 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.
- Derived from this study: PubMed 23643372Conboy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sat Bir S Khalsa, PhD principal investigator
Brigham and Women's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Adolescent Development, run by Brigham and Women's Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01348893, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.