Clinical trial NCT05225103: Brief Suicide Intervention for Youth in Juvenile Detention Settings
Official title: Brief Suicide Intervention for Youth in Juvenile Detention Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide Prevention
Keywords: Juvenile detention
suicidal thoughts
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-02-04
Enrollment: 8
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Trial is Single Group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Suicide Attempts
timeFrame: Up to 2 month follow-up assessment
measure: Non-suicidal Self Injury
timeFrame: Up to 2 month follow-up assessment
measure: Linkage to Mental Health Services After Release
timeFrame: Up to 2 month follow-up assessment
Secondary outcomes:
measure: Urgency to Act on Suicidal Thoughts
timeFrame: Up to 2-month follow-up assessment
measure: Hope and Reasons for Living
timeFrame: Up to 2-month follow-up assessment
measure: Acceptance
timeFrame: Up to 2-month follow-up assessment
measure: Self-Efficacy in Keeping Safe
timeFrame: Up to 2-month follow-up assessment
measure: Emergency Mental Health Services (ED visits and hospitalizations)
timeFrame: Up to 2-month follow-up assessment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: David Goldston, PhD
role: PRINCIPAL_INVESTIGATOR
References: