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临床试验/NCT05583279
NCT05583279撤回不适用

Implementation of Dialectical Behavioral Therapy in Juvenile Justice to Reduce Self-Harm and Increase Quality of Life: A Pilot Test

The Catholic University of America1 个研究点 分布在 1 个国家开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
The Life Problems Inventory (LPI)

研究概览

简要总结

Self-injurious thoughts and behaviors (SITBs) are a serious public health concern, particularly for youth involved in the juvenile justice system (JJS), which the Georgia State Juvenile Justice System (GAJJS) intends to address by the implementation of Dialectical Behavior Therapy (DBT) in its JJS facilities. This proposal aims to support and study the GAJJS' pilot implementation of DBT at its facilities using a mixed-methods cross-over design involving a three-phase clinical trial assessing the feasibility, acceptability, and preliminary effectiveness of DBT-A adapted for youth in the GAJJS. By the end of the proposed project, the investigators will have (1) established a research team to continue researching SITB interventions in the GAJJS, (2) developed protocols for implementing and evaluating DBT-A adapted for the JJS delivered in person and via telehealth, and (3) preliminary data on the feasibility, acceptability, and effectiveness of DBT-A adapted for the JJS.

详细描述

Self-injurious thoughts and behaviors (SITBs) are a serious public health concern across the United States, and youth involved in the juvenile justice system (JJS) are at particularly high-risk for SITBs. As part of the Georgia State Juvenile Justice System (GAJJS)'s decades long collaboration with researchers to reduce the rates of suicide and non-suicidal self-injury (NSSI) among youth under their care, they identified Dialectical Behavior Therapy (DBT) as an ideal intervention to fit their needs and subsequently made plans to pilot an adapted DBT for JJS in a portion of their facilities. DBT is an evidence-based treatment for individuals with complex clinical presentations, which has demonstrated effectiveness at reducing SITBs when adapted for adolescents (DBT-A). Despite its adoption by several JJSs, the effectiveness of DBT-A has yet to be empirically evaluated. A controlled evaluation of DBT-A in JJS is desperately needed to develop a framework for implementation and assess its feasibility, acceptability, and preliminary effectiveness. However, GAJJS does not have the resources or expertise to evaluate the intervention's feasibility, acceptability, and preliminary effectiveness on their own. Therefore, this project proposes to capitalize on this unique opportunity to investigate the GAJJS's implementation of DBT across eight pilot facilities. The investigators propose a mixed-methods cross-over design involving a three-phase clinical trial aimed at assessing the feasibility, acceptability, and preliminary effectiveness of DBT-A adapted for youth in the GAJJS. SITB-related outcomes and DBT-A's feasibility and acceptability will be assessed across two different levels of care (i.e., at short- vs. long-term facilities) and service delivery methods (i.e., in-person vs. telehealth). The project will use feedback from stakeholders, collected at multiple timepoints, to design and iterate the adapted DBT-A program to maximize its feasibility, acceptability, and effectiveness in the GAJJS. The clinical trial will use administrative clinical, health, and educational data of JJS-involved youth to assess how effective DBT-A is at reducing self-harming behaviors and associated risk factors (i.e., deficits in distress tolerance, emotion dysregulation, and interpersonal skills). By the end of the proposed project, the investigators will have (1) established a research team to continue researching SITB interventions in the GAJJS; (2) developed protocols for implementing and evaluating DBT-A adapted for the JJS delivered in person and via telehealth; and (3) preliminary data on the feasibility, acceptability, and effectiveness of DBT-A adapted for the JJS. The investigators will then have the personnel, intervention, and preliminary data to submit an R01 to evaluate the effectiveness of our JJS-adapted DBT-A in a fully powered randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •must be in the custody of the GAJJS and placed at one of the eight facilities participating in the study,
  • •can speak, read, and understand English well enough to participate in a DBT-A therapy program,
  • •there is written informed assent, and
  • •verbal parental/guardian or youth advocate informed consent has been obtained.

排除标准

  • •any youth who are cognitively/decisionally impaired, the GAJJS conducts detailed psycho-diagnostic evaluations on all youth during their intake evaluation - and, part of this evaluation includes a thorough mental status exam, conducted by one of the mental health staff.

研究组 & 干预措施

Phase 2

Experimental

Cohort 1 and 2 youth will then complete baseline assessments (see 4.5) and Cohort 2 will continue receiving TAU while Cohort 1 begins receiving DBT-A (randomized by facility to either in-person or via telehealth delivery) for the next six months while Cohort 1 staff continue consultation with DBT-A. After six months, Phase 2 of this study will conclude with the youth of Cohorts 1 and 2 completing their first follow-up assessment. The implementation plan will be altered accordingly based on feedback from stakeholders prior to the start of Phase 2. The modified implementation plan will be used in the training of the staff in DBT-A at the second four facilities prior to the launch of Phase 3.

干预措施: Dialetical Behavioral Therapy for Adolescents (Behavioral)

No intervention

Active Comparator

Cohort 2 will not receive any treatment during Phase 2 of the study, which is the first part of the clinical trial. They will serve as a comparison group for Cohort 1.

干预措施: Dialetical Behavioral Therapy for Adolescents (Behavioral)

Phase 3

Active Comparator

Phase 3 will begin with making any modifications to the treatment protocol based on a review of feedback from stakeholder interviews from Phase 2. Cohort 2 facilities will be randomized to delivering DBT-A in-person or via telehealth (one long-term and one short-term facility will be assigned to each condition). Staff in Cohort 2 will receive training and consultation in DBT-A and implement either telehealth or in-person delivered DBT-A in their facilities. Cohort 1 facilities will cross-over from in-person delivery of DBT-A to telehealth delivery, or vice-versa, thereby facilitating a within-facility comparison of DBT-A delivery methods. After six months, Phase 3 will conclude with the youth of Cohorts 1 and 2 completing their second follow-up assessment and all stakeholders of Cohorts 1 and 2 completing stakeholder interviews.

干预措施: Dialetical Behavioral Therapy for Adolescents (Behavioral)

结局指标

主要结局

The Life Problems Inventory (LPI)

时间窗: six months to 12 months for cohort 1, six months for cohort 2

Measures the four core treatment components of DBT-A: emotion dysregulation, impulsivity, interpersonal chaos, and confusion about self.

The short form of the self-injurious thoughts and behaviors interview (SITBI)

时间窗: six months to 12 months for cohort 1, six months for cohort 2

Measures changes in suicidal and non-suicidal self-injurious thoughts and behaviors

The DBT-Ways of Coping Check List (DBT-WCCL)

时间窗: six months to 12 months for cohort 1, six months for cohort 2

Measures the use of DBT skills and dysfunctional, non-DBT coping strategies

The Acceptance and Action Questionnaire II (AAQ-II)

时间窗: six months to 12 months for cohort 1, six months for cohort 2

a self-report measure of experiential avoidance

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Dialectical Behavioral Therapy in Juvenile Justice | 临床试验