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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH124986 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAFETY-A Implementation Sites | Experimental | New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAFETY-Acute intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Goldston, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States | ||
| Wake Forest School of Medicine |
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Data were only collected from the 8 youth who were identified as being acutely suicidal and who then received the new intervention.
Eligible youth were asked to assent to the study after being admitted to the facility, and parents and caregivers were then approached for consent.
| ID | Title | Description |
|---|---|---|
| FG000 | SAFETY-A Implementation Sites | New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SAFETY-A Implementation Sites | New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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?" | Data not collected on one participant. | Posted | Count of Participants | Participants | Up to 2 month follow-up assessment |
|
up to 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SAFETY-A Implementation Sites | New Brief Trauma-Informed Intervention (based on SAFETY-A) in addition to Enhanced Usual Care in Juvenile Detention Sites 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt (unverified) | Psychiatric disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Goldston | Duke University | 919-681-1100 | david.goldston@duke.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 4, 2024 | Feb 19, 2025 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2024 | Dec 3, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000092864 | Suicide Prevention |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Open Trial is Single Group.
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| 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 | 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. | 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. | Up to 2-month follow-up assessment |
| Winston-Salem |
| North Carolina |
| 27101 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants Who Reported Non-Suicidal Self Injury | Assessed with Questions from the Self-Injurious Thoughts and Behavior Interview. | Data not collected on one participant. | Posted | Count of Participants | Participants | Up to 2 month follow-up assessment |
|
|
|
| Primary | Number of Participants Who Were Linked to Mental Health Services After Release | Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview. | Data not collected on four participants. | Posted | Count of Participants | Participants | Up to 2 month follow-up assessment |
|
|
|
| Secondary | Number of Participants Reporting Urgency to Act on Suicidal Thoughts | Posted | Count of Participants | Participants | Up to 2-month follow-up assessment |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 2-month follow-up assessment |
|
|
|
| Secondary | Number of Participants Who Report Acceptance of Their Current Situation | Posted | Count of Participants | Participants | Up to 2-month follow-up assessment |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 2-month follow-up assessment |
|
|
|
| Secondary | Number of Individuals With Emergency Mental Health Services (ED Visits and Hospitalizations) | Assessed by CASA (Child and Adolescent Services Assessment) Parent Interview. | Posted | Count of Participants | Participants | Up to 2-month follow-up assessment |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
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