TraumaTIMBYNCT03581461
Trauma-Informed Mindfulness-Based Yoga
A study testing Trauma-Informed Mindfulness-Based Yoga in people with Trauma, run by Georgia State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 21 years, men only
- Conditions the study is for
- Trauma
- What is being tested?
- Trauma-Informed Mindfulness-Based Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Trauma
- Being tested
- Trauma-Informed Mindfulness-Based Yoga
- Keywords
- Trauma, Yoga, Mindfulness
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Informed Mindfulness-Based YogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Trauma-Informed Mindfulness-Based Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
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.
Measured: Baseline and at 6- and 12-weeks follow-up
Changes in anger as assessed by the State-Trait Anger Expression Inventory (STAXI-2)
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.
Measured: 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)
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).
Measured: Baseline and at 6- and 12-weeks follow-up
Changes in impulsivity as assessed by the Barratt Impulsiveness Scale (BIS)
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").
Measured: Baseline and at 6- and 12-weeks follow-up
Changes in psychological flexibility as assessed by the Acceptance and Action Questionnaire (AAQ-II)
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.
Measured: Baseline and at 6- and 12-weeks follow-up
Changes in mindfulness as assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
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."
Measured: Baseline and at 6- and 12-weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start14 Jan 2019
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Foundation Research Institute, UConn Health, New York University
- Responsible party
- Principal investigator, Ashli Owen-Smith, Georgia State University
- Investigators
- Ashli Owen-Smith, PhD, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581461
- Sponsor's protocol ID
- R34AT009538
- Acronym
- TIMBY
- Status last verified
- Sep 2023
- First submitted
- 14 Jun 2018
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-Informed Mindfulness-Based Yoga Intervention for Juvenile Justice-Involved Youth
- ClinicalTrials.gov ID
- NCT03581461
- Acronym / sponsor ID
- TIMBY / R34AT009538
- Conditions
- Trauma
- Keywords
- Trauma, Yoga, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- Kaiser Foundation Research Institute, UConn Health, New York University
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma-Informed Mindfulness-Based Yoga | Experimental | Behavioral: Trauma-Informed Mindfulness-Based YogaThe 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. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma-Informed Mindfulness-Based YogaThe 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. | Behavioural | Trauma-Informed Mindfulness-Based Yoga |
Primary outcome
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).
6 secondary outcomes
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
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
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
Changes in impulsivity as assessed by the Barratt Impulsiveness Scale (BIS)
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashli Owen-Smith, PhD principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Informed Mindfulness-Based Yoga in people with Trauma, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in self-regulation as assessed by the Abbreviated Dysregulation Inventory (ADI) (time frame: Baseline and at 6- and 12-weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.