Brief Suicide Intervention for Youth in Juvenile Detention Settings
Primary Purpose
Suicide Prevention
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SAFETY-Acute intervention
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Suicide Prevention focused on measuring Juvenile detention, suicidal thoughts
Eligibility Criteria
Inclusion Criteria:
- English speaking
- At least 13 years of age and younger than 18 years of age
- 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 or 18 years of age or older
- Evidence from school or other records or suspected intellectual disability
- Active psychosis
Sites / Locations
- Duke UniversityRecruiting
- Wake Forest School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SAFETY-A Implementation Sites
Comparison Implementation Sites
Arm Description
New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites
Enhanced Usual Care in Juvenile Detention Facility
Outcomes
Primary Outcome Measures
Suicide Attempts
Assessed with C-SSRS
Non-suicidal Self Injury
Assessed with SITBI Questions
Linkage to Mental Health Services After Release
Assessed with CASA
Secondary Outcome Measures
Urgency to Act on Suicidal Thoughts
Developed for this study
Hope and Reasons for Living
Adapted from items used by Cyzz et al. (2020) and Zullo et al. (2021)
Acceptance
Developed for this study
Self-Efficacy in Keeping Safe
Adapted from items used by Czyz (2016, 2019)
Emergency Mental Health Services (ED visits and hospitalizations)
Assessed with CASA
Full Information
NCT ID
NCT05225103
First Posted
January 25, 2022
Last Updated
September 7, 2023
Sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05225103
Brief Title
Brief Suicide Intervention for Youth in Juvenile Detention Settings
Official Title
Brief Suicide Intervention for Youth in Juvenile Detention Settings
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an intervention development study and therefore is not designed or powered to test hypotheses. Following initial development and refinement of intervention and protocol, an open trial will be conducted at one juvenile detention facility (n=20). Following further refinement, six juvenile detention sites will be randomized to first or second wave of intervention implementation. All youth at an implementation site in suicidal crises will receive the intervention. Data will only be collected from youth with prior assent/consent. Youth will be assessed at the time of the suicidal/self-harm crisis, just prior to release from the juvenile detention facility, and at a two-month follow-up assessment. We will preliminarily examine feasibility of the intervention and associated patterns of suicidal thoughts and behavior and non-suicidal self-injury, linkage to care following release, and presumed mechanisms of change such as hopelessness, self-efficacy to remain safe, urgency to act on suicidal thoughts, and acceptance.
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. In a pilot randomized trial (n=200) in which the timing of the intervention is randomized across six juvenile detention facilities, the final objective of this study is to collect and examine preliminary data regarding the feasibility of the intervention, as well as indications of the impact of the intervention on suicidal thoughts and behavior, non-suicidal self-harm, emergency services, linkage to care after release, and presumed mechanisms of action.
To address this objective, we will (a) compare data from three intervention sites with three comparison sites that did not receive training in the intervention in the same year (but rather use standard suicide intervention practices); (b) evaluate within-site changes in three sites that were comparison sites in one year but receive the intervention the next year; and (c) examine sustainability of intervention effects in the one year following training in the three sites that initially received the training. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Prevention
Keywords
Juvenile detention, suicidal thoughts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open Trial is Single Group. Pilot RCT is Randomization of Site to Implementation of Intervention (Three Sites in First Wave, Three Sites in Second Wave)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SAFETY-A Implementation Sites
Arm Type
Experimental
Arm Description
New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites
Arm Title
Comparison Implementation Sites
Arm Type
Experimental
Arm Description
Enhanced Usual Care in Juvenile Detention Facility
Intervention Type
Behavioral
Intervention Name(s)
SAFETY-Acute intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
Usual Care in Juvenile Facilities (e.g., suicide watch/observation and evaluation by contracted mental health professional within 24 hours). Usual care is enhanced because of the additional assessment information that can be shared with clinical staff
Primary Outcome Measure Information:
Title
Suicide Attempts
Description
Assessed with C-SSRS
Time Frame
Up to 2 month follow-up assessment
Title
Non-suicidal Self Injury
Description
Assessed with SITBI Questions
Time Frame
Up to 2 month follow-up assessment
Title
Linkage to Mental Health Services After Release
Description
Assessed with CASA
Time Frame
Up to 2 month follow-up assessment
Secondary Outcome Measure Information:
Title
Urgency to Act on Suicidal Thoughts
Description
Developed for this study
Time Frame
Up to 2-month follow-up assessment
Title
Hope and Reasons for Living
Description
Adapted from items used by Cyzz et al. (2020) and Zullo et al. (2021)
Time Frame
Up to 2-month follow-up assessment
Title
Acceptance
Description
Developed for this study
Time Frame
Up to 2-month follow-up assessment
Title
Self-Efficacy in Keeping Safe
Description
Adapted from items used by Czyz (2016, 2019)
Time Frame
Up to 2-month follow-up assessment
Title
Emergency Mental Health Services (ED visits and hospitalizations)
Description
Assessed with CASA
Time Frame
Up to 2-month follow-up assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
English speaking
At least 13 years of age and younger than 18 years of age
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 or 18 years of age or older
Evidence from school or other records or suspected intellectual disability
Active psychosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Goldston, PhD
Phone
919-668-0074
Email
david.goldston@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Goldston, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Goldston, PhD
Phone
919-668-0074
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Daniel, PhD
Phone
336-253-3757
Email
sdaniel@wakehealth.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brief Suicide Intervention for Youth in Juvenile Detention Settings
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