Brief Suicide Intervention for Youth in Juvenile Detention Settings

Suicide Prevention Clinical Trial

Official title:

Brief Suicide Intervention for Youth in Juvenile Detention Settings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05225103
• Other study ID #: Pro00106321
• Secondary ID: R34MH124986
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: David Goldston, PhD
• Phone: 919-668-0074
• Email: david.goldston[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide Prevention

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicide Attempts	Assessed with C-SSRS	Up to 2 month follow-up assessment
Primary	Non-suicidal Self Injury	Assessed with SITBI Questions	Up to 2 month follow-up assessment
Primary	Linkage to Mental Health Services After Release	Assessed with CASA	Up to 2 month follow-up assessment
Secondary	Urgency to Act on Suicidal Thoughts	Developed for this study	Up to 2-month follow-up assessment
Secondary	Hope and Reasons for Living	Adapted from items used by Cyzz et al. (2020) and Zullo et al. (2021)	Up to 2-month follow-up assessment
Secondary	Acceptance	Developed for this study	Up to 2-month follow-up assessment
Secondary	Self-Efficacy in Keeping Safe	Adapted from items used by Czyz (2016, 2019)	Up to 2-month follow-up assessment
Secondary	Emergency Mental Health Services (ED visits and hospitalizations)	Assessed with CASA	Up to 2-month follow-up assessment