An interventional study of Dialetical Behavioral Therapy for Adolescents in Non-Suicidal Self Injury, Suicide and Self-harm, sponsored by The Catholic University of America. Withdrawn at 1 site in United States. Open to participants aged 10 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by The Catholic University of America · Not applicable, Interventional, and Treatment
Among 386 studies in Suicide with a site in United States — 99 open to participants now, 113 under way, 2 of them phase 3. Suicide · United States.
Among the 386 studies in Suicide with a site in United States, this one is the 339th largest by enrollment of the 348 interventional ones, is one of 29 that started in 2024, is one of 288 with no phase, and was the 268th registered.
607 studies on the registry are indexed under Suicide; 162 are open to participants now.
Browse Suicide studies →99 of the 386 studies in Suicide with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 114 Suicide studies recruiting now, 54 (47%) set no upper age limit and 57 (50%) stop at 75 or younger; 52 take children under 18; 24 take healthy volunteers.
This study: 10 Years to 21 Years · all sexes · healthy volunteers too.
The full table on the hub →386 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 29 started in 2024.
Median enrollment 91 across the 348 interventional studies, 172 across the 36 observational. Of the 251 that completed or were terminated, 103 (41%) have results posted.
15 of 386 have an industry lead sponsor. The 10 most frequent:
The Catholic University of America is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
The Catholic University of America has 2 studies filed under Suicide — fewer than ten, so there is no comparison to draw.
43 of the studies in Suicide with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05696691Phase 3The University of Texas Health Science Center at San AntonioKetamine & Crisis Response Plan for Suicidal Ideation in the ED | 2026-12-31 |
| NCT05558332University of California, IrvineYouth Nominated Support Team | 2026-11 |
| NCT06470867VA Office of Research and DevelopmentRandomized Controlled Effectiveness Trial of VA S.A.V.E. | 2026-11-27 |
| NCT05897164Evidence-Based Practice Institute, Seattle, WAMobile Technology to Reduce Teen Substance Misuse | 2026-11-30 |
| NCT06460220Jennifer HughesSAFETY-Parent: Online Learning Module to Support Parents of Suicidal Youth | 2026-12 |
Among the 386 studies in Suicide with a site in United States, from their registry updates:
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.
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.
607 studies on the registry are indexed under Suicide; 162 are open to participants now.
Browse Suicide studies →The Catholic University of America is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Compared within Suicide, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Self-Injurious Behavior. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 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.
The short form of the self-injurious thoughts and behaviors interview (SITBI)
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
The Life Problems Inventory (LPI)
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
The DBT-Ways of Coping Check List (DBT-WCCL)
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
The Acceptance and Action Questionnaire II (AAQ-II)
a self-report measure of experiential avoidance
Time frame: six months to 12 months for cohort 1, six months for cohort 2
Plan to share: 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".
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
Start is estimated for Feb 2024; primary completion for Aug 2026, 30 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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