Suicide PreventionNCT05225103
Brief Suicide Intervention for Youth in Juvenile Detention Settings
A study testing SAFETY-Acute intervention in people with Suicide Prevention, run by Duke University at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- SAFETY-Acute intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Apr 2023to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University
Durham, North Carolina, 27705
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27101
About this study
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.
Read the 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
- Being tested
- SAFETY-Acute intervention
- Keywords
- Juvenile detention, suicidal thoughts
- Medical subject headings
- Suicide Prevention, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFETY-Acute interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SAFETY-A Implementation Sites | Experimental | New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites Receives: Behavioral: SAFETY-Acute intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: 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.
Measured: 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.
Measured: Up to 2 month follow-up assessment
Secondary outcomes (5)
Number of Participants Reporting Urgency to Act on Suicidal Thoughts
Measured: Up to 2-month follow-up assessment
Number of Participants Reporting Hope and Reasons for Living After Leaving the Facility
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.
Measured: Up to 2-month follow-up assessment
Number of Participants Who Report Acceptance of Their Current Situation
Measured: Up to 2-month follow-up assessment
Number of Participants Reporting Self-Efficacy in Keeping Safe
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.
Measured: Up to 2-month follow-up assessment
Number of Individuals With Emergency Mental Health Services (ED Visits and Hospitalizations)
Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview.
Measured: Up to 2-month follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start7 Apr 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Trial is Single Group.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- David Goldston, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225103
- Sponsor's protocol ID
- Pro00106321
- Other IDs
- R34MH124986
- Status last verified
- Jul 2025
- First submitted
- 25 Jan 2022
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Suicide Intervention for Youth in Juvenile Detention Settings
- ClinicalTrials.gov ID
- NCT05225103
- Acronym / sponsor ID
- Pro00106321
- Conditions
- Suicide Prevention
- Keywords
- Juvenile detention, suicidal thoughts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Trial is Single Group.
| Arm | Type | Receives |
|---|---|---|
| SAFETY-A Implementation Sites | Experimental | Behavioral: SAFETY-Acute interventionNew Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAFETY-Acute interventionThe 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. | Behavioural | SAFETY-A Implementation Sites |
Primary outcome
Number of Participants Who Reported Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 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?"
Number of Participants Who Reported Non-Suicidal Self Injury
Time frame: Up to 2 month follow-up assessment
Assessed with Questions from the Self-Injurious Thoughts and Behavior Interview.
Number of Participants Who Were Linked to Mental Health Services After Release
Time frame: Up to 2 month follow-up assessment
Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview.
5 secondary outcomes
Number of Participants Reporting Urgency to Act on Suicidal Thoughts
Time frame: Up to 2-month follow-up assessment
Number of Participants Reporting Hope and Reasons for Living After Leaving the Facility
Time frame: Up to 2-month follow-up assessment
Number of Participants Who Report Acceptance of Their Current Situation
Time frame: Up to 2-month follow-up assessment
Number of Participants Reporting Self-Efficacy in Keeping Safe
Time frame: Up to 2-month follow-up assessment
Number of Individuals With Emergency Mental Health Services (ED Visits and Hospitalizations)
Time frame: Up to 2-month follow-up assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Goldston, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAFETY-Acute intervention in people with Suicide Prevention, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Reported Suicide Attempts as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS) (time frame: Up to 2 month follow-up assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.