Clinical trial NCT01821950: Evaluation of Yoga for Substance Use Risk Factors in a School Setting
Official title: Evaluation of Yoga for Substance Use Risk Factors in a School Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Development
Keywords: Mental health
Substance use
Substance use initiation
Education
Mind Body Therapies
Yoga
Meditation
Adolescent
Adolescence
Child
Children
Middle School
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Kripalu Center for Yoga and Health
name: Boston University
First posted: 2013-04-01
Enrollment: 211
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Registered for physical education class

Primary outcomes:
measure: Change in self-reported mood as measured by the 24-item Brunel University Mood Scale (BRUMS, total and 6 sub-scales)
timeFrame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
measure: Change in self-reported stress levels as measured by the 10-item Perceived Stress Scale (PSS)
timeFrame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
measure: 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)
timeFrame: 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).
timeFrame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
measure: Change in self-reported anger control and anger rumination as measured by the Children's Anger Management Scale (2 sub-scales)
timeFrame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
measure: Change in self-reported sadness control and sadness rumination as measured by the Children's Sadness Management Scale (CSMS) (2 sub-scales)
timeFrame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
measure: Change in self-reported affective lability as measured by the Affective Lability Scale (originally 54 items, adapted to 10 items)
timeFrame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
measure: Change in self-reported anger coping, problem solving, situation redefinition, impatience, and self-criticism as measured by the Wills Coping Inventory (5 sub-scales)
timeFrame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
measure: Change in self-reported positive self-reinforcement as measured by the 8-item Heiby Self-Reinforcement Inventory
timeFrame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
measure: Change in self-reported present and future time perspective as measured by the Zimbardo Time Perspective Inventory (2 sub-scales)
timeFrame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
measure: Change in self-reported impulsiveness as measured by the Eysenck Impulsiveness Questionnaire (EIQ) (1 subscale)
timeFrame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
measure: Change in self-reported substance use as measured by the Youth Risk Behavior Survey (YRBS) (4 subscales)
timeFrame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
measure: Change in self-reported substance use willingness as measured by the 13-item Substance Use Willingness Questionnaire
timeFrame: Baseline; 1 week post-intervention; 6 months post-intervention; 1 year post-intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Latin School
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Sat Bir S Khalsa, PhD
role: PRINCIPAL_INVESTIGATOR
References: