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Dialectical Behavioral Therapy in Juvenile Justice (DBT-A&JJS)

Primary Purpose

Non-Suicidal Self Injury, Suicide, Self-harm

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialetical Behavioral Therapy for Adolescents
Sponsored by
The Catholic University of America
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Suicidal Self Injury focused on measuring dialectical behavioral therapy, adolescents, self-injury, suicide, juvenile justice

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Catholic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Phase 2

No intervention

Phase 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

The short form of the self-injurious thoughts and behaviors interview (SITBI)
Measures changes in suicidal and non-suicidal self-injurious thoughts and behaviors
The Life Problems Inventory (LPI)
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)
Measures the use of DBT skills and dysfunctional, non-DBT coping strategies
The Acceptance and Action Questionnaire II (AAQ-II)
a self-report measure of experiential avoidance

Secondary Outcome Measures

Full Information

First Posted
October 13, 2022
Last Updated
October 19, 2022
Sponsor
The Catholic University of America
Collaborators
Butler Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05583279
Brief Title
Dialectical Behavioral Therapy in Juvenile Justice
Acronym
DBT-A&JJS
Official Title
Implementation of Dialectical Behavioral Therapy in Juvenile Justice to Reduce Self-Harm and Increase Quality of Life: A Pilot Test
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Catholic University of America
Collaborators
Butler Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Suicidal Self Injury, Suicide, Self-harm, Emotion Regulation
Keywords
dialectical behavioral therapy, adolescents, self-injury, suicide, juvenile justice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 2
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Phase 3
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dialetical Behavioral Therapy for Adolescents
Intervention Description
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.
Primary Outcome Measure Information:
Title
The short form of the self-injurious thoughts and behaviors interview (SITBI)
Description
Measures changes in suicidal and non-suicidal self-injurious thoughts and behaviors
Time Frame
six months to 12 months for cohort 1, six months for cohort 2
Title
The Life Problems Inventory (LPI)
Description
Measures the four core treatment components of DBT-A: emotion dysregulation, impulsivity, interpersonal chaos, and confusion about self.
Time Frame
six months to 12 months for cohort 1, six months for cohort 2
Title
The DBT-Ways of Coping Check List (DBT-WCCL)
Description
Measures the use of DBT skills and dysfunctional, non-DBT coping strategies
Time Frame
six months to 12 months for cohort 1, six months for cohort 2
Title
The Acceptance and Action Questionnaire II (AAQ-II)
Description
a self-report measure of experiential avoidance
Time Frame
six months to 12 months for cohort 1, six months for cohort 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa D Grady, PhD
Phone
2023194387
Email
grady@cua.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David Jobes, PhD
Phone
(202) 319-5761
Email
jobes@cua.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa D Grady, PhD
Organizational Affiliation
Catholic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20064
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Grady, PhD
Phone
202-319-4387
Email
grady@cua.edu
First Name & Middle Initial & Last Name & Degree
JoAnn Regan, PhD
Phone
202-319-5472
Email
reganj@cua.edu
First Name & Middle Initial & Last Name & Degree
Christopher Hughes, PhD
First Name & Middle Initial & Last Name & Degree
David Jobes, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Catholic University of America is committed to the open and timely dissemination of research outcomes. Investigators in this proposed program recognize that promising new methods, technologies, data, software programs, and insights may arise during the course of their research. All investigators are aware of and agree to abide by the principles for sharing research resources, as described by NIH in, "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs".
IPD Sharing Time Frame
the data will become available one year after completion of the trial and will be available for three years.
IPD Sharing Access Criteria
Researchers who work within juvenile justice systems.
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Dialectical Behavioral Therapy in Juvenile Justice

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