Trauma-Informed Mindfulness-Based Yoga

NCT03581461 | Completed DMC

• 1 other identifier: R34AT009538
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study aims to gather the multiple types of preliminary data needed to design a large and rigorous pragmatic, cluster randomized trial on the impact of a trauma-informed mindfulness-based yoga program on enhancing self-regulation (in the short-term) and reducing recidivism (in the long-term) among juvenile justice-involved youth. Such a study will ultimately provide more definitive outcomes related to the effectiveness of these programs this population. If effective, the assimilation of such programs into the treatment plans of youth in juvenile justice facilities and in other residential settings could have a significant impact on a range of health, educational, vocational, and interpersonal outcomes relevant to this population.

Conditions

Trauma

Keywords

Trauma; Yoga; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Changes in self-regulation as assessed by the Abbreviated Dysregulation Inventory (ADI)

  The primary outcome of interest is changes in self-regulation, which will be assessed using the Abbreviated Dysregulation Inventory (ADI). The ADI is a 30-item self-report measure designed to assess 3 aspects of dysregulation - cognitive, emotional and behavioral - among adolescents. Each item on the ADI is rated on a four-point scale from 0 (never true) to 3 (always true).

  Baseline and at 6- and 12-weeks follow-up

Secondary Outcomes (6)

• Changes in externalizing and internalizing behavior as assessed by The Child Behavior Checklist - Youth Self-Report (YSR).

  Baseline and at 6- and 12-weeks follow-up

• Changes in anger as assessed by the State-Trait Anger Expression Inventory (STAXI-2)

  Baseline and at 6- and 12-weeks follow-up

• Changes in trauma-related symptoms as assessed by the Structured Trauma-Related Experiences and Symptoms Screener (STRESS)

  Baseline and at 6- and 12-weeks follow-up

• Changes in impulsivity as assessed by the Barratt Impulsiveness Scale (BIS)

  Baseline and at 6- and 12-weeks follow-up

• Changes in psychological flexibility as assessed by the Acceptance and Action Questionnaire (AAQ-II)

  Baseline and at 6- and 12-weeks follow-up

Study Arms (1)

Trauma-Informed Mindfulness-Based Yoga

EXPERIMENTAL

The TIMBY program will involve twice weekly, 1-hour long sessions that will incorporate the central elements of Hatha Yoga - breathwork (pranayama), physical postures (asana) and meditation.

Behavioral: Trauma-Informed Mindfulness-Based Yoga

Interventions

Trauma-Informed Mindfulness-Based Yoga BEHAVIORAL

The TIMBY program will involve twice weekly, 1-hour long sessions that will incorporate the central elements of Hatha Yoga - breathwork (pranayama), physical postures (asana) and meditation.

Trauma-Informed Mindfulness-Based Yoga

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Detained at DeKalb Regional Youth Detention Center or the Atlanta Youth Development Campus (YDC)
• On the mental health caseload
• Male
• Ages 13-21
• English-speaking
• Able to understand and comply with study procedures for the entire length of the study

You may not qualify if:

• Recent (within the last week) serious non-compliant behavior (e.g., episodes of violent behavior requiring restraints or resulting in legal charges)
• Have current, untreated psychosis
• Are cognitively or decisionally impaired
• Are Wards of the State of Georgia

Sponsors & Collaborators

• Georgia State University: lead
• Kaiser Foundation Research Institute: collaborator
• UConn Health: collaborator
• New York University: collaborator

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Ashli Owen-Smith, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 10, 2018
• Study Start: January 14, 2019
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)