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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05583279
Other study ID # CUA-002
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date August 31, 2026

Study information

Verified date February 2024
Source The Catholic University of America
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 31, 2026
Est. primary completion date August 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 21 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Catholic University Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
The Catholic University of America Butler Hospital

Country where clinical trial is conducted

United States, 

References & Publications (32)

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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. — View Citation

Chugani CD, Mitchell ME, Botanov Y, Linehan MM. Development and Initial Evaluation of the Psychometric Properties of the Dialectical Behavior Therapy Barriers to Implementation Scale (BTI-S). J Clin Psychol. 2017 Dec;73(12):1704-1716. doi: 10.1002/jclp.22478. Epub 2017 Apr 5. — View Citation

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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. — View Citation

David Rudd M, Bryan CJ, Jobes DA, Feuerstein S, Conley D. A Standard Protocol for the Clinical Management of Suicidal Thoughts and Behavior: Implications for the Suicide Prevention Narrative. Front Psychiatry. 2022 Jul 12;13:929305. doi: 10.3389/fpsyt.2022.929305. eCollection 2022. — View Citation

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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. — View Citation

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. — View Citation

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Kothgassner OD, Goreis A, Robinson K, Huscsava MM, Schmahl C, Plener PL. Efficacy of dialectical behavior therapy for adolescent self-harm and suicidal ideation: a systematic review and meta-analysis. Psychol Med. 2021 May;51(7):1057-1067. doi: 10.1017/S0033291721001355. Epub 2021 Apr 20. — View Citation

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Pistorello J, Jobes DA, Compton SN, Locey NS, Walloch JC, Gallop R, Au JS, Noose SK, Young M, Johnson J, Dickens Y, Chatham P, Jeffcoat T, Dalto G, Goswami S. Developing Adaptive Treatment Strategies to Address Suicidal Risk in College Students: A Pilot Sequential, Multiple Assignment, Randomized Trial (SMART). Arch Suicide Res. 2017 Oct-Dec;22(4):644-664. doi: 10.1080/13811118.2017.1392915. Epub 2018 Feb 12. — View Citation

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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. — View Citation

Ruch DA, Sheftall AH, Schlagbaum P, Fontanella CA, Campo JV, Bridge JA. Characteristics and Precipitating Circumstances of Suicide Among Incarcerated Youth. J Am Acad Child Adolesc Psychiatry. 2019 May;58(5):514-524.e1. doi: 10.1016/j.jaac.2018.07.911. Epub 2019 Jan 23. — View Citation

Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009 May;62(5):464-75. doi: 10.1016/j.jclinepi.2008.12.011. — View Citation

Wilkinson PO. Dialectical Behavior Therapy-A Highly Effective Treatment for Some Adolescents Who Self-harm. JAMA Psychiatry. 2018 Aug 1;75(8):786-787. doi: 10.1001/jamapsychiatry.2018.1079. No abstract available. — View Citation

* Note: There are 32 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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