DBT-A&JJS: Dialectical Behavioral Therapy in Juvenile Justice

Sponsor

The Catholic University of America (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05583279

Collaborator

Butler Hospital (Other)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Suicidal Self Injury Suicide Self-harm Emotion Regulation	Behavioral: Dialetical Behavioral Therapy for Adolescents	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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).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).

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2026

Anticipated Study Completion Date :

Aug 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Active Comparator: 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.

Behavioral: Dialetical Behavioral Therapy for Adolescents

Active Comparator: 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.

Behavioral: Dialetical Behavioral Therapy for Adolescents

Outcome Measures

Primary Outcome Measures

The short form of the self-injurious thoughts and behaviors interview (SITBI) [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 Life Problems Inventory (LPI) [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 DBT-Ways of Coping Check List (DBT-WCCL) [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) [six months to 12 months for cohort 1, six months for cohort 2]
a self-report measure of experiential avoidance

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic University	Washington	District of Columbia	United States	20064

Sponsors and Collaborators

The Catholic University of America
Butler Hospital

Investigators

Principal Investigator: Melissa D Grady, PhD, Catholic University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

The Catholic University of America

ClinicalTrials.gov Identifier:

NCT05583279

Other Study ID Numbers:

CUA-002

First Posted:

Oct 17, 2022

Last Update Posted:

Oct 20, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The Catholic University of America

dialectical behavioral therapy

Additional relevant MeSH terms:

Suicide

Self-Injurious Behavior

Study Results

No Results Posted as of Oct 20, 2022