- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06547008
Army-SPRING Army-Suicide Prevention Research
Army-Suicide Prevention Research on Implementation in the National Guard (Army-SPRING)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Attachment 4: Lay Abstract Objective 1: The first objective is to spend 6 months collecting feedback from Army National Guard Soldiers and their family, the religious affairs team, and leadership on how best to reduce risk for suicide. We will also collect feedback from Suicide Intervention Officers, who are appointed to reduce risk for suicide in their unit, about how to support these officers in their important work.
Objective 2: The second objective is to compare two strategies to support Suicide Intervention Officers as they work closely with soldiers to reduce their risk for suicide. The 47 Suicide Intervention Officers in the Connecticut Army National Guard will be randomly assigned (like the flip of a coin) to one of two groups. The first group will attend an extra training (Control Group). The second group will become part of a community focused on reducing suicide risk, including access to online forums to support them in their work, support in leading Battle Drills focused on suicide prevention, and additional training and consultation (Army-SPRING Group). Chaplains/religious affairs specialists will also receive the Army-SPRING group training, but will not be randomized since there are only 5 total Chaplains and 5 religious affairs specialists.
Objective 3: The third objective is to study whether soldiers with Suicide Intervention Officers in the Army-SPRING Group (described in objective 2) report lower rates of suicide ideation and attempts than the Control Group.
Rationale: Every unit in the Connecticut Army National Guard has a Suicide Intervention Officer to provide suicide intervention education awareness for their unit, monitor for soldiers in crisis and connect soldiers with helping resources and agencies. Suicide Intervention Officers need support in this difficult role, yet there is limited guidance on how to help them. This study will shed light on how to support Suicide Intervention Officers and whether this support results in reduced suicide risk in their units.
CBPR Approach and Implementation: We have formed a community advisory board that includes Veterans of Army National Guard units in other states (Pennsylvania); Veterans of the Army with employment as a civilian in the Marines, Chaplains in the Connecticut National Guard on the Air Force (who are intimately familiar with the needs at CT but who are not employees of the Army National Guard), and members of the Suicide Prevention Task force. We have asked for their feedback on the design of the study and will meet with them monthly for the three months and then quarterly thereafter.
FY23 TBIPHRP HSRA Focus Area: This project relates to the Prevent and Assess area of encouragement namely: "Development, evaluation, and implementation of crosscutting prevention approaches targeting upstream factors or leveraging communities and peers to address multiple adverse outcomes such as suicide." Types of Patients Helped by the Research and How it will Help Them: This research will help Army National Guard Soldiers, who are at higher risk for suicide than Active Duty service members. It will help them by supporting Suicide Intervention Officers as they work to reduce risk for suicide among soldiers.
Potential clinical applications, Benefits and Risks: The clinical application is a strategy to support Suicide Intervention Officers, which could benefit soldiers in reducing their suicide risk.
Projected timeline: 4 years, including 6 months of preparatory work with our community advisory board, who will also provide input throughout.
Health and well-being of Service Members: This will help the health and well-being of service members by reducing their risk for suicide. It will help Suicide Intervention Officers by improving their confidence in supporting soldiers who are struggling with suicide risk. It will help Chaplains/Religious affairs specialists who regularly desire more training in suicide prevention and who are a well-used source of support for soldiers at risk.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Lily A Brown, PhD
- Phone Number: 215-746-3346
- Email: lilybr@pennmedicine.upenn.edu
Study Contact Backup
- Name: Marin Kautz, PhD
- Phone Number: 805-235-7100
- Email: marin.kautz@pennmedicine.upenn.edu
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06103
- Not yet recruiting
- Connecticut Army National Guard
-
Contact:
- Laura Stamatien, BS
- Phone Number: 860-391-3799
- Email: laura.e.stamatien.mil@army.mil
-
New Haven, Connecticut, United States, 06520
- Active, not recruiting
- Yale University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Center for the Treatment and Study of Anxiety, University of Pennsylvania
-
Contact:
- Lily A Brown, PhD
- Phone Number: 215-746-3346
- Email: lilybr@pennmedicine.upenn.edu
-
Contact:
- Marin Kautz, PhD
- Phone Number: 8052357100
- Email: marin.kautz@pennmedicine.upenn.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Serving as an SIO or chaplain/religious affairs specialist for a unit of the CTARNG
- Willing to provide informed consent.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Risk Reduction Group (Control)
Risk Reduction Group is a mandated training from National Guard Service members
|
Risk Reduction Group is a mandated training from National Guard Service members
|
|
Experimental: Army-SPRING
Army-SPRING includes a package of implementation options to support implementation of suicide prevention duties
|
Army-SPRING includes a package of implementation options to support implementation of suicide prevention duties
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reach - Interactions with soldiers involving discussions about suicide risk
Time Frame: Weekly for 1 year
|
Number of soldier interactions reporting suicide risk/Total number of interactions with soldiers
|
Weekly for 1 year
|
|
Reach - Self
Time Frame: Year 1
|
Use of suicide prevention services for self, URI-3 item 75
|
Year 1
|
|
Reach - Intervening for others
Time Frame: Year 1
|
Use of suicide prevention services for buddy, URI-3 item 74
|
Year 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicidal ideation
Time Frame: Year 1
|
URI-3 item 15
|
Year 1
|
|
Suicide plans:
Time Frame: Year 1
|
URI-3 item 15a
|
Year 1
|
|
Suicide attempts
Time Frame: Year 1
|
URI-3 item 15b
|
Year 1
|
|
Adoption
Time Frame: Up to 24 months
|
Suicide intervention officer willingness to initiate all SIO duties; This will be operationalized as the total number of SIOs who reported willingness to complete all their suicide prevention-related activities
|
Up to 24 months
|
|
Implementation
Time Frame: Up to 24 months
|
Fidelity to all assigned suicide intervention officer duties; Fidelity will be assessed using self-report by the SIO, including the following questions: 1) Does your battalion know that you are their SIO?; and 2) Have you completed any trainings related to suicide prevention with your battalion?
Finally, among SIOs randomized to ARMY-SPRING, we will assess their fidelity of leading the battle drills in a manner consistent with suicide prevention principals.
|
Up to 24 months
|
|
Acceptability
Time Frame: Up to 24 months
|
Acceptability of Intervention Measure (AIM)
|
Up to 24 months
|
|
Appropriateness
Time Frame: Up to 24 months
|
Intervention appropriateness measure (IAM)
|
Up to 24 months
|
|
Qualitative Interviews
Time Frame: Up to 24 months
|
Qualitative Interviews (Acceptability, appropriateness, climate, etc.)
|
Up to 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intentions, attitudes, norms
Time Frame: Baseline, quarterly, year 1, year 2
|
Theory of Planned Behavior Questionnaire
|
Baseline, quarterly, year 1, year 2
|
|
Organizational culture
Time Frame: Baseline, quarterly, year 1, year 2
|
We use the support subscale of the Implementation Leadership Scale to assess how leadership influences implementation outcomes.
Organizational culture measures the culture and climate in their battalion, feasibility and acceptability of implementing suicide prevention tasks
|
Baseline, quarterly, year 1, year 2
|
|
Maintenance
Time Frame: Up to 24 months
|
Suicidal ideation: URI-3 item 15; Suicide plans: URI-3 item 15a
|
Up to 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ashley Hagaman, PhD, Yale University
- Principal Investigator: Lily Brown, PhD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 855941
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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