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

NCT01821950 | Completed

• 2 other identifiers: 2007P002600BR34DA032756
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adolescent Development

Keywords

Mental health; Substance use; Substance use initiation; Education; Mind Body Therapies; Yoga; Meditation; Adolescent; Adolescence; Child; Children; Middle School

Outcome Measures

Primary Outcomes (3)

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

  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.

  Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention

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

  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.

  Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention

• 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)

  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.

  Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention

Secondary Outcomes (10)

• 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 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 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 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

Study Arms (2)

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.

Behavioral: Yoga during physical education

Interventions

Yoga during physical education BEHAVIORAL

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.

Also known as: Kripalu Yoga In The Schools

Yoga during physical education

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Registered for physical education class

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Kripalu Center for Yoga and Health: collaborator
• Boston University: collaborator

Study Sites (1)

Boston Latin School

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Psychological Well-Being; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sat Bir S Khalsa, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 1, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

US (1)