NCT05583279

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.

Trial Health

50
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
3mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Feb 2024Aug 2026

First Submitted

Initial submission to the registry

October 13, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

October 13, 2022

Last Update Submit

February 7, 2024

Conditions

Keywords

dialectical behavioral therapyadolescentsself-injurysuicidejuvenile justice

Outcome Measures

Primary Outcomes (4)

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

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

    six months to 12 months for cohort 1, six months for cohort 2

  • The Life Problems Inventory (LPI)

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

    six months to 12 months for cohort 1, six months for cohort 2

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

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

    six months to 12 months for cohort 1, six months for cohort 2

  • The Acceptance and Action Questionnaire II (AAQ-II)

    a self-report measure of experiential avoidance

    six months to 12 months for cohort 1, six months for cohort 2

Study Arms (3)

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.

Behavioral: Dialetical Behavioral Therapy for Adolescents

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.

Behavioral: Dialetical Behavioral Therapy for Adolescents

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.

Behavioral: Dialetical Behavioral Therapy for Adolescents

Interventions

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 interventionPhase 2Phase 3

Eligibility Criteria

Age10 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University

Washington D.C., District of Columbia, 20064, United States

Location

Related Publications (32)

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    PMID: 30768395BACKGROUND
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    PMID: 29926089BACKGROUND
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    PMID: 30661567BACKGROUND
  • Lynch TR, Chapman AL, Rosenthal MZ, Kuo JR, Linehan MM. Mechanisms of change in dialectical behavior therapy: theoretical and empirical observations. J Clin Psychol. 2006 Apr;62(4):459-80. doi: 10.1002/jclp.20243.

    PMID: 16470714BACKGROUND
  • Rathus JH, Miller AL. Dialectical behavior therapy adapted for suicidal adolescents. Suicide Life Threat Behav. 2002 Summer;32(2):146-57. doi: 10.1521/suli.32.2.146.24399.

    PMID: 12079031BACKGROUND
  • Carson-Wong A, Hughes CD, Rizvi SL. The effect of therapist use of validation strategies on change in client emotion in individual dbt treatment sessions. Personal Disord. 2018 Mar;9(2):165-171. doi: 10.1037/per0000229. Epub 2016 Dec 5.

    PMID: 27918168BACKGROUND
  • Cooperman NA, Rizvi SL, Hughes CD, Williams JM. Field Test of a Dialectical Behavior Therapy Skills Training-Based Intervention for Smoking Cessation and Opioid Relapse Prevention in Methadone Treatment. J Dual Diagn. 2019 Jan-Mar;15(1):67-73. doi: 10.1080/15504263.2018.1548719. Epub 2019 Jan 15.

    PMID: 30646819BACKGROUND
  • Rizvi SL, Hughes CD, Hittman AD, Vieira Oliveira P. Can Trainees Effectively Deliver Dialectical Behavior Therapy for Individuals With Borderline Personality Disorder? Outcomes From a Training Clinic. J Clin Psychol. 2017 Dec;73(12):1599-1611. doi: 10.1002/jclp.22467. Epub 2017 Feb 21.

    PMID: 28221671BACKGROUND
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    PMID: 29220633BACKGROUND
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    PMID: 24885904BACKGROUND
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  • Fox KR, Harris JA, Wang SB, Millner AJ, Deming CA, Nock MK. Self-Injurious Thoughts and Behaviors Interview-Revised: Development, reliability, and validity. Psychol Assess. 2020 Jul;32(7):677-689. doi: 10.1037/pas0000819. Epub 2020 Apr 23.

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  • Nock MK, Holmberg EB, Photos VI, Michel BD. Self-Injurious Thoughts and Behaviors Interview: development, reliability, and validity in an adolescent sample. Psychol Assess. 2007 Sep;19(3):309-17. doi: 10.1037/1040-3590.19.3.309.

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  • Neacsiu AD, Rizvi SL, Linehan MM. Dialectical behavior therapy skills use as a mediator and outcome of treatment for borderline personality disorder. Behav Res Ther. 2010 Sep;48(9):832-9. doi: 10.1016/j.brat.2010.05.017. Epub 2010 May 23.

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  • Harned MS, Korslund KE, Schmidt SC, Gallop RJ. The Dialectical Behavior Therapy Adherence Coding Scale (DBT ACS): Psychometric properties. Psychol Assess. 2021 Jun;33(6):552-561. doi: 10.1037/pas0000999. Epub 2021 Mar 25.

    PMID: 33764118BACKGROUND

Related Links

MeSH Terms

Conditions

Self-Injurious BehaviorSuicideEmotional Regulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-ControlSocial Behavior

Study Officials

  • Melissa D Grady, PhD

    Catholic University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 17, 2022

Study Start

February 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

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".

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
the data will become available one year after completion of the trial and will be available for three years.
Access Criteria
Researchers who work within juvenile justice systems.

Locations