Non-Suicidal Self InjuryDBT-A&JJSNCT05583279
Dialectical Behavioral Therapy in Juvenile Justice
A study testing Dialetical Behavioral Therapy for Adolescents in people with Non-Suicidal Self Injury and Suicide, run by The Catholic University of America at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Suicidal Self Injury, Suicide, Self-harm
- What is being tested?
- Dialetical Behavioral Therapy for Adolescents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 31 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Catholic University
Washington D.C., District of Columbia, 20064
About this study
Official title: Implementation of Dialectical Behavioral Therapy in Juvenile Justice to Reduce Self-Harm and Increase Quality of Life: A Pilot Test
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.
Read the 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.
- Conditions
- Non-Suicidal Self Injury, Suicide, Self-harm, Emotion Regulation
- Being tested
- Dialetical Behavioral Therapy for Adolescents
- Keywords
- dialectical behavioral therapy, adolescents, self-injury, suicide, juvenile justice
- Medical subject headings
- Self-Injurious Behavior, Suicide, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialetical Behavioral Therapy for AdolescentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Dialetical Behavioral Therapy for Adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
The short form of the self-injurious thoughts and behaviors interview (SITBI)
Measures changes in suicidal and non-suicidal self-injurious thoughts and behaviors
Measured: 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.
Measured: 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
Measured: 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
Measured: six months to 12 months for cohort 1, six months for cohort 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Feb 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Why it stopped: We never started the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Non-Suicidal Self InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of America
- Sponsor type
- University, hospital or other
- Collaborators
- Butler Hospital
- Responsible party
- Sponsor
- Investigators
- Melissa D Grady, PhD, Principal investigator, Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583279
- Sponsor's protocol ID
- CUA-002
- Acronym
- DBT-A&JJS
- Status last verified
- Feb 2024
- First submitted
- 13 Oct 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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".
Publications
Ludtke J, In-Albon T, Schmeck K, Plener PL, Fegert JM, Schmid M. Nonsuicidal Self-Injury in Adolescents Placed in Youth Welfare and Juvenile Justice Group Homes: Associations with Mental Disorders and Suicidality. J Abnorm Child Psychol. 2018 Feb;46(2):343-354. doi: 10.1007/s10802-017-0291-8.
PubMed 28374220Abram KM, Choe JY, Washburn JJ, Teplin LA, King DC, Dulcan MK. Suicidal ideation and behaviors among youths in juvenile detention. J Am Acad Child Adolesc Psychiatry. 2008 Mar;47(3):291-300. doi: 10.1097/CHI.0b013e318160b3ce.
PubMed 18216737Linehan MM. Dialectical behavior therapy for borderline personality disorder. Theory and method. Bull Menninger Clin. 1987 May;51(3):261-76. No abstract available.
PubMed 3580661Kothgassner 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.
PubMed 33875025Moscicki EK. Gender differences in completed and attempted suicides. Ann Epidemiol. 1994 Mar;4(2):152-8. doi: 10.1016/1047-2797(94)90062-0.
PubMed 8205283Clarke S, Allerhand LA, Berk MS. Recent advances in understanding and managing self-harm in adolescents. F1000Res. 2019 Oct 24;8:F1000 Faculty Rev-1794. doi: 10.12688/f1000research.19868.1. eCollection 2019.
PubMed 31681470Cibis A, Mergl R, Bramesfeld A, Althaus D, Niklewski G, Schmidtke A, Hegerl U. Preference of lethal methods is not the only cause for higher suicide rates in males. J Affect Disord. 2012 Jan;136(1-2):9-16. doi: 10.1016/j.jad.2011.08.032. Epub 2011 Sep 19.
PubMed 21937122Carmel A, Rose ML, Fruzzetti AE. Barriers and solutions to implementing dialectical behavior therapy in a public behavioral health system. Adm Policy Ment Health. 2014 Sep;41(5):608-14. doi: 10.1007/s10488-013-0504-6.
PubMed 23754686Thorpe 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.
PubMed 19348971Ruch 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.
PubMed 30768395Wilkinson 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.
PubMed 29926089James AC, Taylor A, Winmill L, Alfoadari K. A Preliminary Community Study of Dialectical Behaviour Therapy (DBT) with Adolescent Females Demonstrating Persistent, Deliberate Self-Harm (DSH). Child Adolesc Ment Health. 2008 Sep;13(3):148-152. doi: 10.1111/j.1475-3588.2007.00470.x. Epub 2007 Dec 14.
PubMed 32847177McAllister-Williams RH, Young AH. Pindolol augmentation of antidepressant therapy. Br J Psychiatry. 1998 Dec;173:536-7. doi: 10.1192/bjp.173.6.536b. No abstract available.
PubMed 9926087DeCou CR, Comtois KA, Landes SJ. Dialectical Behavior Therapy Is Effective for the Treatment of Suicidal Behavior: A Meta-Analysis. Behav Ther. 2019 Jan;50(1):60-72. doi: 10.1016/j.beth.2018.03.009. Epub 2018 Mar 22.
PubMed 30661567Lynch 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.
PubMed 16470714