NCT05225103

Brief Suicide Intervention for Youth in Juvenile Detention Settings

Completed NA Results posted Last updated 19 August 2025

What this trial tests

NA trial testing SAFETY-Acute intervention in Suicide Prevention in 8 participants. Completed in 29 February 2024.

Timeline

7 April 2023

Primary endpoint
29 February 2024

29 February 2024

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	7 April 2023
Primary completion	29 February 2024
Estimated completion	29 February 2024
Sites	2 locations across United States

Drugs / interventions tested

• SAFETY-Acute intervention

Conditions studied

• Suicide Prevention — all drugs for Suicide Prevention →

Sponsor

Duke University

Who can join

Adults 13 to 18, any sex, with Suicide Prevention. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Reported Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS) Primary · 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?"

Group	Value	95% CI
SAFETY-A Implementation Sites	1

Number of Participants Who Reported Non-Suicidal Self Injury Primary · Up to 2 month follow-up assessment

Assessed with Questions from the Self-Injurious Thoughts and Behavior Interview.

Group	Value	95% CI
SAFETY-A Implementation Sites	1

Number of Participants Who Were Linked to Mental Health Services After Release Primary · Up to 2 month follow-up assessment

Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview.

Group	Value	95% CI
SAFETY-A Implementation Sites	3

Number of Participants Reporting Urgency to Act on Suicidal Thoughts Secondary · Up to 2-month follow-up assessment

Group	Value	95% CI
SAFETY-A Implementation Sites	1

Number of Participants Reporting Hope and Reasons for Living After Leaving the Facility Secondary · 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.

Group	Value	95% CI
SAFETY-A Implementation Sites	6

Number of Participants Who Report Acceptance of Their Current Situation Secondary · Up to 2-month follow-up assessment

Group	Value	95% CI
SAFETY-A Implementation Sites	7

Number of Participants Reporting Self-Efficacy in Keeping Safe Secondary · 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.

Group	Value	95% CI
SAFETY-A Implementation Sites	6

Number of Individuals With Emergency Mental Health Services (ED Visits and Hospitalizations) Secondary · Up to 2-month follow-up assessment

Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview.

Group	Value	95% CI
SAFETY-A Implementation Sites	0

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 2 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SAFETY-A Implementation Sites

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (1 terms — click to expand)

Reaction	System	SAFETY-A Implementation Si…
Suicide attempt (unverified)	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT05225103 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.