Trauma-Informed Mindfulness-Based Yoga (TIMBY)

September 18, 2023 updated by: Ashli Owen-Smith, Georgia State University

Trauma-Informed Mindfulness-Based Yoga Intervention for Juvenile Justice-Involved Youth

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are a number of interventions that aim to reduce recidivism among youth in the juvenile justice (JJ) system, some of which have documented evidence of effectiveness. However, the average reduction in recidivism following the implementation of these programs is modest at best, leaving a majority of JJ-involved youth at risk for recidivism. Many previous interventions have not been designed to address trauma-related symptoms despite evidence that most youth in the JJ system have a history of trauma and exposure to traumatic events is a predictor of recidivism. The pathway by which trauma exposure can lead to and perpetuate delinquency may be explained by some of the survival-oriented biological changes that occur in the brain of children who have been exposed to trauma - namely the compromised self-regulation systems that are responsible for reward/motivation, distress tolerance and executive function. As a result, youth with a history of trauma often have an impaired ability to modulate their behavioral and cognitive responses to a wide range of stressors. Thus, in light of the prevalence of trauma exposure in this population, interventions for JJ-involved youth should address trauma and, specifically, provide youth with resources related to enhancing self-regulation skills. Though some trauma-informed interventions have demonstrated empirical evidence of effectiveness with JJ-involved youth, many have methodological limitations and have not tested whether complementary mindfulness or somatically-oriented interventions can reduce recidivism by enhancing self-regulation in this population. The investigators propose to refine, implement and evaluate a trauma-informed, mindfulness-based yoga intervention that will enhance self-regulation among youth in the Georgia Department of Juvenile Justice (DJJ) system. The objectives of this mixed-methods investigation are to refine and pilot a trauma-informed, mindfulness-based yoga (TIMBY) program, assess the preliminary impact of this program on youth behavioral and psychosocial outcomes and test key aspects of the study design to inform the design of a full scale trial. The aims of this proposal are: (1) employ an iterative drafting and revision process to refine a trauma-informed yoga intervention specifically for youth in the JJ system, (2) conduct an initial pilot of the draft TIMBY intervention with JJ-involved youth at 2 DJJ facilities and (3) conduct and evaluate a small scale feasibility study of the TIMBY intervention. The expected products of the proposed research include a refined intervention protocol and manual of procedures, preliminary data regarding the impact of the intervention on participant outcomes, and data on intervention acceptability, adherence, fidelity, dose/duration, participant recruitment, retention and attrition, assessment feasibility and other barriers and facilitators to large-scale implementation. These products and data will enable a rapid launch of a subsequent, large-scale pragmatic cluster RCT funded through a future application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Georgia State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Trauma-Informed Mindfulness-Based Yoga
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in self-regulation as assessed by the Abbreviated Dysregulation Inventory (ADI)
Time Frame: Baseline and at 6- and 12-weeks follow-up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in externalizing and internalizing behavior as assessed by The Child Behavior Checklist - Youth Self-Report (YSR).
Time Frame: Baseline and at 6- and 12-weeks follow-up
Internalizing and externalizing behaviors will be measured using two subscales from The Child Behavior Checklist - Youth Self-Report (YSR). The YSR (18) is a self-report questionnaire divided in two parts: 1) Competencies and 2) Problems. It consists of 112 problem items covering different symptoms/behaviors each to be rated on a three-point scale (2 indicates that the symptom is present most of the time or applies well, 1 indicates that the symptom is present some of the time or applies to some extent, and 0 indicates the absence of symptom or problem behavior). All ratings refer to symptoms or problems experienced during the preceding 6 months.
Baseline and at 6- and 12-weeks follow-up
Changes in anger as assessed by the State-Trait Anger Expression Inventory (STAXI-2)
Time Frame: Baseline and at 6- and 12-weeks follow-up
Anger will be measured using the 57-item State-Trait Anger Expression Inventory (STAXI-2) which assesses youth's experience with and expression/control of anger. Specifically, the STAXI-2 includes self-report scales that measure State Anger, Trait Anger, Anger Expression-Out, Anger Expression-In, Anger Control-Out, Anger Control-In, and Anger Expression Index. Ratings are on a 4-point forced-choice response scale ("Not at all" to "Almost Always"). The State Anger scale measures transient anger intensity, while the Trait Anger scale measures the frequency of angry feelings. The Anger Expression-In scale measures the extent to which one "holds things in" or suppresses anger, whereas the Anger Expression-Out scale measures the actual expression of aggression. The Anger Control-In scale measures the extent to which the suppression of anger is controlled, whereas the Anger Control-Out scale measures the constraint of overt anger expression.
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)
Time Frame: Baseline and at 6- and 12-weeks follow-up
Trauma-related symptoms will be assessed using the Structured Trauma-Related Experiences and Symptoms Screener (STRESS) which inventories 25 adverse childhood experiences/potentially traumatic events and assesses symptoms of PTSD. The STRESS assesses the four DSM-5 PTSD symptom clusters, dissociative symptoms, and trauma-related functional impairment (i.e., ability to make or keep friends, get along with other kids, do schoolwork, get along with teachers, get along with household, and get chores done) using 21 items measured on a 4-point rating scale (none, 1 day, 2-3 days, and most days). The STRESS uses a briefer retrospective time frame when assessing symptoms based on evidence that children's retrospective report is less valid over an extended period of time (De Los Reyes & Kazdin, 2005).
Baseline and at 6- and 12-weeks follow-up
Changes in impulsivity as assessed by the Barratt Impulsiveness Scale (BIS)
Time Frame: Baseline and at 6- and 12-weeks follow-up
Impulsivity will be assessed using the Barratt Impulsiveness Scale (BIS), which is a 30-item 4-point rating scale ("rarely/never" to "almost always/always") and captures 3 domains of impulsivity: cognitive impulsiveness which involves making quick decisions (e.g., "I make up my mind quickly"), motor impulsiveness which involves acting without thinking (e.g., "I act on the spur of the moment"), and non-planning impulsiveness which involve a lack of ''futuring" or forethought (e.g., "I am more interested in the present than the future").
Baseline and at 6- and 12-weeks follow-up
Changes in psychological flexibility as assessed by the Acceptance and Action Questionnaire (AAQ-II)
Time Frame: Baseline and at 6- and 12-weeks follow-up
Psychological flexibility will be assessed using the Acceptance and Action Questionnaire (AAQ-II) is the most widely used measure of experiential avoidance and psychological inflexibility. The AAQ-II is a seven-item self-report measure that uses a 7-point Likert scale (1=never true, 7=always true). Sample items include "I am afraid of my feelings" and "Emotions cause problems in my life." Three of the AAQ-II items are taken directly from the nine-item AAQ.
Baseline and at 6- and 12-weeks follow-up
Changes in mindfulness as assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Time Frame: Baseline and at 6- and 12-weeks follow-up
Mindfulness will be assessed using the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) is a 12-item measure designed to measure four core characteristics of mindfulness described by Kabat-Zinn (1990): (1) the ability to regulate attention ["I have a hard time concentrating on what I am doing," (reverse-scored)], (2) an orientation to present or immediate experience [e.g., "I focus on the present moment", "I am preoccupied with the past" (reverse scored)], (3) awareness of experience (e.g., "It's easy for me to keep track of my thoughts and feelings"), and (4) an attitude of acceptance or nonjudgment towards experience (e.g., "I believe it is OK to be sad or angry"). Participants respond on a 4-point Likert scale from "Rarely/not at all" to "Almost always."
Baseline and at 6- and 12-weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Georgia State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
New York University
Kaiser Foundation Research Institute
UConn Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ashli Owen-Smith, PhD, Georgia State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34AT009538 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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