NCT05225103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 7, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 19, 2025

Completed
Last Updated

August 19, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

January 25, 2022

Results QC Date

February 20, 2025

Last Update Submit

July 31, 2025

Conditions

Keywords

Juvenile detentionsuicidal thoughts

Outcome Measures

Primary Outcomes (3)

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

    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?"

    Up to 2 month follow-up assessment

  • Number of Participants Who Reported Non-Suicidal Self Injury

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

    Up to 2 month follow-up assessment

  • Number of Participants Who Were Linked to Mental Health Services After Release

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

    Up to 2 month follow-up assessment

Secondary Outcomes (5)

  • Number of Participants Reporting Urgency to Act on Suicidal Thoughts

    Up to 2-month follow-up assessment

  • Number of Participants Reporting Hope and Reasons for Living After Leaving the Facility

    Up to 2-month follow-up assessment

  • Number of Participants Who Report Acceptance of Their Current Situation

    Up to 2-month follow-up assessment

  • Number of Participants Reporting Self-Efficacy in Keeping Safe

    Up to 2-month follow-up assessment

  • Number of Individuals With Emergency Mental Health Services (ED Visits and Hospitalizations)

    Up to 2-month follow-up assessment

Study Arms (1)

SAFETY-A Implementation Sites

EXPERIMENTAL

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

Behavioral: SAFETY-Acute intervention

Interventions

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.

SAFETY-A Implementation Sites

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University

Durham, North Carolina, 27705, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27101, United States

Location

MeSH Terms

Conditions

Suicide PreventionSuicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Limitations and Caveats

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. Full implementation at all but one of the facilities was challenging because of overcrowding and understaffing.

Results Point of Contact

Title
David Goldston
Organization
Duke University

Study Officials

  • David Goldston, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open Trial is Single Group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2022

First Posted

February 4, 2022

Study Start

April 7, 2023

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

August 19, 2025

Results First Posted

August 19, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations