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临床试验/NCT03581461
NCT03581461已完成不适用

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

Georgia State University2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2019年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
2
主要终点
Changes in self-regulation as assessed by the Abbreviated Dysregulation Inventory (ADI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 21 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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).

次要结局

  • 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)
  • Changes in mindfulness as assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)(Baseline and at 6- and 12-weeks follow-up)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashli Owen-Smith

Assistant Professor

Georgia State University

研究点 (2)

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