Overview

This trial is active, not recruiting.

Condition adolescent development
Treatment yoga during physical education
Sponsor Brigham and Women's Hospital
Collaborator National Institute on Drug Abuse (NIDA)
Start date September 2013
End date June 2016
Trial size 283 participants
Trial identifier NCT01821950, 2007P002600B, R34DA032756

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(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.
(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.
yoga during physical education 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.

Primary Outcomes

Measure
Change in self-reported mood as measured by the 24-item Brunel University Mood Scale (BRUMS, total and 6 sub-scales)
time frame: 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)
time frame: 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)
time frame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention

Secondary Outcomes

Measure
Change in self-reported soothability, planfulness, and distractibility as measured by the Kendall-Wilcox Self-Control Schedule (3 sub-scales).
time frame: 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)
time frame: 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)
time frame: 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)
time frame: 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)
time frame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
Change in self-reported positive self-reinforcement as measured by the 8-item Heiby Self-Reinforcement Inventory
time frame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
Change in self-reported present and future time perspective as measured by the Zimbardo Time Perspective Inventory (2 sub-scales)
time frame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
Change in self-reported impulsiveness as measured by the Eysenck Impulsiveness Questionnaire (EIQ) (1 subscale)
time frame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
Change in self-reported substance use as measured by the Youth Risk Behavior Survey (YRBS) (4 subscales)
time frame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
Change in self-reported substance use willingness as measured by the 13-item Substance Use Willingness Questionnaire
time frame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention

Eligibility Criteria

Male or female participants from 11 years up to 14 years old.

Inclusion Criteria: - Registered for physical education class

Additional Information

Official title Evaluation of Yoga for Substance Use Risk Factors in a School Setting
Principal investigator Sat Bir S Khalsa, PhD
Description The long-term, programmatic goal of this research is to advance prevention of addictive behaviors especially substance use in normal adolescent psychological development. The overall goal of this proposal is to pilot test a novel, preventive intervention for adolescent substance use. More specifically, it 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. This study involves a group randomized, controlled trial of yoga compared to physical education-as-usual for one school year, with a 6-month and 1-year follow-up, in order to accomplish the following specific aims: Specific Aim 1 - To evaluate the efficacy of a school-based yoga program for reducing negative internalizing behaviors (negative mood, perceived stress, impulsivity) which are risk factors for adolescent substance use. Specific Aim 2 - To evaluate the efficacy of this yoga program for promoting self-regulatory skills as protective factors against substance use in adolescence. Specific Aim 3 - To conduct a preliminary evaluation of the efficacy of this yoga program for reducing substance use initiation and severity of use.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.