Dialectical Behavioral Therapy in Juvenile Justice

NCT ID: NCT05583279

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-Suicidal Self Injury Suicide Self-harm Emotion Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The proposed project consists of a mixed-methods cross-over design involving a three-phase clinical trial aimed at assessing the feasibility, acceptability, and preliminary effectiveness of comprehensive DBT-A adapted for youth in the GAJJS. DBT-A/outcomes 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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 2

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.

Group Type EXPERIMENTAL

Dialetical Behavioral Therapy for Adolescents

Intervention Type BEHAVIORAL

DBT is an evidence-based treatment for individuals with complex clinical presentations, including borderline personality disorder (BPD), suicidality, and NSSI. Standard DBT (which includes individual therapy, skills group, between-session skills coaching, and peer consultation for therapists) is associated with symptom reductions in patients across a variety of domains, including BPD symptoms, SA, NSSI, hospitalizations, and social functioning. DBT focuses on teaching skills (e.g., emotion regulation) and facilitating the replacement of impulsive and/or ineffective behaviors (e.g., NSSI), with more effective/skillful behaviors.

No intervention

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.

Group Type ACTIVE_COMPARATOR

Dialetical Behavioral Therapy for Adolescents

Intervention Type BEHAVIORAL

DBT is an evidence-based treatment for individuals with complex clinical presentations, including borderline personality disorder (BPD), suicidality, and NSSI. Standard DBT (which includes individual therapy, skills group, between-session skills coaching, and peer consultation for therapists) is associated with symptom reductions in patients across a variety of domains, including BPD symptoms, SA, NSSI, hospitalizations, and social functioning. DBT focuses on teaching skills (e.g., emotion regulation) and facilitating the replacement of impulsive and/or ineffective behaviors (e.g., NSSI), with more effective/skillful behaviors.

Phase 3

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.

Group Type ACTIVE_COMPARATOR

Dialetical Behavioral Therapy for Adolescents

Intervention Type BEHAVIORAL

DBT is an evidence-based treatment for individuals with complex clinical presentations, including borderline personality disorder (BPD), suicidality, and NSSI. Standard DBT (which includes individual therapy, skills group, between-session skills coaching, and peer consultation for therapists) is associated with symptom reductions in patients across a variety of domains, including BPD symptoms, SA, NSSI, hospitalizations, and social functioning. DBT focuses on teaching skills (e.g., emotion regulation) and facilitating the replacement of impulsive and/or ineffective behaviors (e.g., NSSI), with more effective/skillful behaviors.

Interventions

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Dialetical Behavioral Therapy for Adolescents

DBT is an evidence-based treatment for individuals with complex clinical presentations, including borderline personality disorder (BPD), suicidality, and NSSI. Standard DBT (which includes individual therapy, skills group, between-session skills coaching, and peer consultation for therapists) is associated with symptom reductions in patients across a variety of domains, including BPD symptoms, SA, NSSI, hospitalizations, and social functioning. DBT focuses on teaching skills (e.g., emotion regulation) and facilitating the replacement of impulsive and/or ineffective behaviors (e.g., NSSI), with more effective/skillful behaviors.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

\- 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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Butler Hospital

OTHER

Sponsor Role collaborator

The Catholic University of America

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melissa D Grady, PhD

Role: PRINCIPAL_INVESTIGATOR

Catholic University

Locations

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Catholic University

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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Related Links

Access external resources that provide additional context or updates about the study.

https://www.cdc.gov/injury/wisqars/index.html

Center for Disease Control Injury Data

https://www.courts.ca.gov/documents/BTB25-1G-02.pdf

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https://bpded.biomedcentral.com/articles/10.1186/s40479-021-00167-5

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Other Identifiers

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CUA-002

Identifier Type: -

Identifier Source: org_study_id

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