Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-01-03 @ 6:47 PM
Study NCT ID:
NCT03581461
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2018-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trauma-Informed Mindfulness-Based Yoga
Sponsor:
Georgia State University
Organization:
Study Overview
Official Title:
Trauma-Informed Mindfulness-Based Yoga Intervention for Juvenile Justice-Involved Youth
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIMBY
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: