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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Dialectical Behavioral Therapy in Juvenile Justice to Reduce Self-Harm and Increase Quality of Life: A Pilot Test
- ClinicalTrials.gov ID
- NCT05583279
- Acronym / sponsor ID
- DBT-A&JJS / CUA-002
- Conditions
- Non-Suicidal Self Injury, Suicide, Self-harm, Emotion Regulation
- Keywords
- dialectical behavioral therapy, adolescents, self-injury, suicide, juvenile justice
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We never started the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Catholic University of AmericaUniversity, hospital or other
- Collaborators
- Butler Hospital
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Phase 2 | Experimental | Behavioral: Dialetical Behavioral Therapy for AdolescentsCohort 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. |
| No intervention | Active comparator | Behavioral: Dialetical Behavioral Therapy for AdolescentsCohort 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 | Active comparator | Behavioral: Dialetical Behavioral Therapy for AdolescentsPhase 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. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialetical Behavioral Therapy for AdolescentsDBT 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. | Behavioural | No intervention, Phase 2, Phase 3 |
Primary outcome
The short form of the self-injurious thoughts and behaviors interview (SITBI)
Time frame: six months to 12 months for cohort 1, six months for cohort 2
Measures changes in suicidal and non-suicidal self-injurious thoughts and behaviors
The Life Problems Inventory (LPI)
Time frame: six months to 12 months for cohort 1, six months for cohort 2
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)
Time frame: six months to 12 months for cohort 1, six months for cohort 2
Measures the use of DBT skills and dysfunctional, non-DBT coping strategies
The Acceptance and Action Questionnaire II (AAQ-II)
Time frame: six months to 12 months for cohort 1, six months for cohort 2
a self-report measure of experiential avoidance
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Background: PubMed 28374220Ludtke 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.
- Background: PubMed 18216737Abram 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.
- Background: PubMed 3580661Linehan MM. Dialectical behavior therapy for borderline personality disorder. Theory and method. Bull Menninger Clin. 1987 May;51(3):261-76. No abstract available.
- Background: PubMed 33875025Kothgassner 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.
- Background: PubMed 8205283Moscicki EK. Gender differences in completed and attempted suicides. Ann Epidemiol. 1994 Mar;4(2):152-8. doi: 10.1016/1047-2797(94)90062-0.
- Background: PubMed 31681470Clarke 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.
- Background: PubMed 21937122Cibis 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.
- Background: PubMed 23754686Carmel 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.
- Background: PubMed 19348971Thorpe 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.
- Background: PubMed 30768395Ruch 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.
- Background: PubMed 29926089Wilkinson 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.
- Background: PubMed 32847177James 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.
- Ford JD, Chapman JF, Hawke J, Albert D. Trauma among youth in the juvenile justice system: Critical issues and new directions. National Center for Mental Health and Juvenile Justice. 2007;6:2007.Link provided by the sponsor.
- Wilks CR, Gurtovenko K. Virtual delivery of dialectical behavior therapy. In: Rolnik A, ed. Advances in online therapy. ; in press.Link provided by the sponsor.
- National Action Alliance for Suicide Prevention: Research Prioritization Task Force. A prioritized research agenda for suicide prevention: An action plan to save lives. . 2014.Link provided by the sponsor.
- Courtney-Seidler, E. A., Burns, K., Zilber, I., \& Miller, A. L. (2014). Adolescent suicide and self-injury: Deepening the understanding of the biosocial theory and applying dialectical behavior therapy.Link provided by the sponsor.
- Drake EK, Barnoski RP. Recidivism findings for the juvenile rehabilitation administration's mentoring program. Washington State Institute for Public Policy; 2006.Link provided by the sponsor.
- Harned MS, Coyle TN, Garcia NM. The inclusion of ethnoracial, sexual, and gender minority groups in randomized controlled trials of dialectical behavior therapy: A systematic review of the literature. Clinical Psychology: Science and Practice. 2022.Link provided by the sponsor.
- Individual participant dataSharing planned: 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".
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa D Grady, PhD principal investigator
Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The short form of the self-injurious thoughts and behaviors interview (SITBI) (time frame: six months to 12 months for cohort 1, six months for cohort 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05583279, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.