- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05225103
Brief Suicide Intervention for Youth in Juvenile Detention Settings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this phase of the study is to develop and refine procedures for the new multi-faceted intervention for trauma-informed suicide prevention (brief cognitive-behavioral and trauma-informed strategies and safety planning for youth who are suicidal and/or self-harming, as well as training of staff in trauma-informed crisis management and de-escalation strategies) for youth in juvenile detention settings. An associated objective is to develop procedures for training staff working with youth in short-term juvenile detention settings to conduct the new intervention for reducing suicidal thoughts and behavior. A third objective is to examine the feasibility of this trauma-informed suicide prevention intervention in terms of initial participant recruitment, fidelity to the treatment model, treatment acceptability, and monitoring of adverse events in an open trial (n=20). This intervention will be iteratively refined during this open trial based on feedback from youth and staff, and experiences using the intervention in juvenile detention. We will also gather information regarding the presumed mechanisms of action and targeted outcomes for this intervention (although the small open trial will not be able to statistically examine effects).
As an intervention development study, this study is not powered to test hypotheses. Rather, the purpose of this study is to demonstrate feasibility and acceptability of the intervention and procedures, and to demonstrate viability of the proof of concept.
The study is a collaboration between Duke and Wake Forest investigators, and Juvenile Justice in the NC Department of Public Safety.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University
-
Winston-Salem, North Carolina, United States, 27101
- Wake Forest School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English speaking
- At least 13 years of age or older and 18 years old or younger
- Without evidence from school or other records of intellectual disability
- Without evidence of active psychosis
- Not wards of the state
- Risk for suicidal behavior or non-suicidal self-harm behavior
Exclusion Criteria:
- Not English-speaking or caregivers are not English-speaking
- Wards of the state
- Younger than 13 years old or older than 18 years of age
- Evidence from school or other records or suspected intellectual disability
- Active psychosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SAFETY-A Implementation Sites
New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites
|
The trauma-informed brief suicide intervention based on the SAFETY-A (single crisis session in addition to follow-up caring contacts).
Delivered in addition to usual care in facilities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Reported Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to 2 month follow-up assessment
|
Determined by a response of "yes" to question #6 on the C-SSRS: "Have you done anything, started to do anything, or prepared to do anything to end your life?"
|
Up to 2 month follow-up assessment
|
|
Number of Participants Who Reported Non-Suicidal Self Injury
Time Frame: Up to 2 month follow-up assessment
|
Assessed with Questions from the Self-Injurious Thoughts and Behavior Interview.
|
Up to 2 month follow-up assessment
|
|
Number of Participants Who Were Linked to Mental Health Services After Release
Time Frame: Up to 2 month follow-up assessment
|
Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview.
|
Up to 2 month follow-up assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Reporting Urgency to Act on Suicidal Thoughts
Time Frame: Up to 2-month follow-up assessment
|
Up to 2-month follow-up assessment
|
|
|
Number of Participants Reporting Hope and Reasons for Living After Leaving the Facility
Time Frame: Up to 2-month follow-up assessment
|
Adapted from items used by Cyzz et al. (2020) and Zullo et al. (2021).
Number of participants who report they strongly agree that they have hope for the future and reasons for living after leaving the facility.
|
Up to 2-month follow-up assessment
|
|
Number of Participants Who Report Acceptance of Their Current Situation
Time Frame: Up to 2-month follow-up assessment
|
Up to 2-month follow-up assessment
|
|
|
Number of Participants Reporting Self-Efficacy in Keeping Safe
Time Frame: Up to 2-month follow-up assessment
|
Adapted from items used by Czyz (2016, 2019).
The number of participants reporting that they very much agreed that they felt confident in keeping themselves safe is reported.
|
Up to 2-month follow-up assessment
|
|
Number of Individuals With Emergency Mental Health Services (ED Visits and Hospitalizations)
Time Frame: Up to 2-month follow-up assessment
|
Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview.
|
Up to 2-month follow-up assessment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Goldston, PhD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00106321
- R34MH124986 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicide Prevention
-
Mental Health Services in the Capital Region, DenmarkKarolinska InstitutetCompleted
-
University of Sao PauloNot yet recruitingSuicide Ideation | Suicide Attempts
-
University of North Carolina, Chapel HillVillage Heartbeat, Inc.RecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
VA Office of Research and DevelopmentNot yet recruiting
-
George Washington UniversityUniversity of Rochester; Mt. Sinai School of Medicine, New York, New York; American...Recruiting
-
Fundació Institut de Recerca de l'Hospital de la...Not yet recruitingSuicide | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionSpain
-
VA Office of Research and DevelopmentNot yet recruiting
-
Yale UniversityNational Institute of Mental Health (NIMH); PossibleRecruiting
-
University GhentRecruitingSuicidal Ideation | Suicide | Suicide PreventionBelgium
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); Robert Wood Johnson FoundationRecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
Clinical Trials on SAFETY-Acute intervention
-
San Diego State UniversityNational Institute of Mental Health (NIMH)Active, not recruitingSuicideUnited States
-
VA Office of Research and DevelopmentCompleted
-
New York State Psychiatric InstituteWithdrawn
-
Children's Hospital of PhiladelphiaAcademic Pediatric AssociationCompletedHospitalizationUnited States
-
Milton S. Hershey Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National... and other collaboratorsCompletedChild ObesityUnited States
-
Boston Children's HospitalAgency for Healthcare Research and Quality (AHRQ); Pediatric Research in Inpatient...RecruitingQuality Improvement | Patient Safety | Family Reported Errors and Adverse Events | Health Disparities | Family Safety Reporting | Voluntary Incident ReportingUnited States
-
Michigan State UniversityBrown UniversityCompletedSuicideUnited States
-
Boston Children's HospitalCompletedFamily Reported Errors and Adverse EventsUnited States
-
University of Massachusetts, WorcesterHealth Resources and Services Administration (HRSA)CompletedPosttraumatic Stress Disorder
-
Region SkaneForteRecruitingSuicide AttemptSweden