Brief Suicide Intervention for Youth in Juvenile Detention Settings

NCT ID: NCT05225103

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-07
• Study Completion Date: 2024-02-29

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, and at 2 and 4 weeks after initial intervention, 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. 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.

Conditions

Suicide Prevention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAFETY-A Implementation Sites

New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites

Group Type: EXPERIMENTAL

SAFETY-Acute intervention

Intervention Type: BEHAVIORAL

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.

Interventions

SAFETY-Acute intervention

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

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Goldston, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R34MH124986

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00106321

Identifier Type: -

Identifier Source: org_study_id