Crisis Response PlanNCT07032636
Reducing Crises and Suicide Within the Idaho Army National Guard
A study testing Crisis Intervention - The First Line Leaders (FLL) program will utilize templated guides developed with stakeholders from the Idaho Army National Guard (ARNG), known as the Total Health Action Plan (T in people with Crisis Response Plan and Crisis Intervention, run by University of Rochester at 1 site in United States.
Trial summary
Military suicide is an ongoing public health concern, particularly within the Army National Guard (ARNG), with longstanding effects on fellow soldiers, family, and friends. The straddling of military and civilian worlds for ARNG can worsen risk factors for suicide, including increased social isolation, disruption to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crisis Response Plan, Crisis Intervention
- What is being tested?
- Crisis Intervention - The First Line Leaders (FLL) program will utilize templated guides developed with stakeholders from the Idaho Army National Guard (ARNG), known as the Total Health Action Plan (T
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enlistment or commission in the Idaho ARNG at the time of enrollment
- Age 18 or greater
- Ability to complete all study questionnaires and interview procedures
- Has at least one year remaining on National Guard contract
Who cannot join
- Less than one year remaining on their contract with the National Guard
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Idaho Army National Guard
Boise, Idaho, 83716
Todd Stevens, 208-272-8303, todd.m.stevens10.mil@army.mil
About this study
Official title: Reducing Crises and Suicide Within the Idaho Army National Guard - Enhancement of the First Line Leader Program
Military suicide is an ongoing public health concern, particularly within the Army National Guard (ARNG), with longstanding effects on fellow soldiers, family, and friends. The straddling of military and civilian worlds for ARNG can worsen risk factors for suicide, including increased social isolation, disruption to family life, and employment difficulties. One promising framework that addresses both unit cohesion and social support is the First Line Leaders (FLL) program, recently designated by ARNG for nation-wide dissemination. The program is centered on enhancing the relationship between junior enlisted soldiers (JES) and their assigned non-commissioned officer (NCO). The Investigators propose to study an augmented FLL program that includes templated guides developed in collaboration with Idaho ARNG stakeholders. The guides, referred to as TAP (Total Health Action Plan), were adapted from two empirically based interventions, Crisis Response Planning and Problem-Solving Therapy, and consist of prompts for open communication and effective engagement and guidelines for responding to impending or current behavioral distress. Given their elevated suicide risk, the Idaho ARNG is a crucial setting to develop this upstream intervention.
In this study, the Investigators propose to compare the augmented FLL + TAP program to FLL only, and training as usual (n= 50 NCOs and 100 JES per group) with quarterly assessments for up to one year. The Investigators will examine a random selection of deidentified counseling templates to examine the type and frequency of counseling sessions involving acute crisis and behavioral health difficulties, and online ratings from a random selection of JES using validated instruments to assess upstream indicators of behavioral distress and suicide risk and resilience. The Investigators will also conduct qualitative interviews with a random selection of 20% of the NCOs (n = 30) and JES (n = 60) enrolled in the project to provide personalized perspectives of program experiences.
The Investigators propose three aims to guide this research. (1) Collaborate with Idaho ARNG stakeholders to integrate TAP into FLL programming via: a) development and refinement of TAP training materials, b) building templated counseling statements that align with FLL and TAP, and c) education of Idaho ARNG training cadre in the delivery of TAP. (2) Evaluate fidelity, feasibility, and acceptability of FLL and FLL + TAP through a mixed methods approach of qualitative interviews with FLLs and JESs and evaluation of data from templated counseling sessions. (3) Examine the impact of FLL+TAP versus FLL versus training as usual on unit morale, cohesion, and general functioning.
- Conditions
- Crisis Response Plan, Crisis Intervention
- Being tested
- Crisis Intervention - The First Line Leaders (FLL) program will utilize templated guides developed with stakeholders from the Idaho Army National Guard (ARNG), known as the Total Health Action Plan (T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisis Intervention - The First Line Leaders (FLL) program will utilize templated guides developed with stakeholders from the Idaho Army National Guard (ARNG), known as the Total Health Action Plan (TBehavioural
The Investigators are developing training programs for soldiers and leaders to enhance their communication skills, problem-solving abilities, and approachability. They will be randomized to one of three different groups.
| Study group | Role | What they receive |
|---|---|---|
| FLL + TAP | Active comparator | This will be a 1-day initial training that incorporates 12 leadership meetings, delivered during monthly drill weekends, and the FLLs will discuss program feasibility and acceptability with the program leadership. In addition to the standard FLL training, this group will learn about the Total Health Action Plan (TAP) and how to deploy it with their soldiers. The Investigators will measure fidelity of TAP delivery, soldier engagement and satisfaction rates, and whether NCOs are more responsive to soldiers reporting problems. Receives: Behavioral: Crisis Intervention - The First Line Leaders (FLL) program will utilize templated guides developed with stakeholders from the Idaho Army National Guard (ARNG), known as the Total Health Action Plan (T |
| FLL | Active comparator | This is the existing 1-day initial training that incorporates 12 leadership meetings, delivered during monthly drill weekends currently being delivered by the Idaho Army National Guard. FLLs will discuss program feasibility and acceptability with the program leadership. Receives: Behavioral: Crisis Intervention - The First Line Leaders (FLL) program will utilize templated guides developed with stakeholders from the Idaho Army National Guard (ARNG), known as the Total Health Action Plan (T |
| No FLL | No intervention | Participants assigned to this condition will receive training as usual and have not been assigned FLL training by the Idaho Army National Guard. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Fidelity to TAP.
Fidelity to TAP will be assessed by examining counseling statements where an intervention was completed on the templated counseling statement forms generated by our Stakeholder Advisory Board (SAB) using a Likert-type scale (e.g., 1 = poor fidelity, 5 = excellent fidelity). The total range of possible scores is from 1 to 5, with higher scores indicating better fidelity.
Measured: Baseline, Month 3, Month 6, Month 9, and, Month 12.
Estimate of TAP usage at Follow-Up Assessments
Participants will be asked to complete a survey item assessing how many times they used a TAP during the 3-, 6-, 9-, and 12-month follow-up visits. Response options will range from 0 to 99. The higher the score, the more TAPs the participant estimates they used during the given assessment period.
Measured: Baseline, Month 3, Month 6, Month 9, and Month 12
Mean satisfaction with TAP while in the FLL training program
Participants will be asked to complete a survey called Client Satisfaction Questionnaire (CSQ). CSQ items are rated on a Likert-type scale that ranges from 0 to 4, with the higher total score indicating greater satisfaction with the intervention.
Measured: Baseline, Month 3, Month 6, Month 9, and, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start15 Jun 2026
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crisis Response PlanStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Idaho Army National Guard
- Responsible party
- Principal investigator, Todd Bishop, University of Rochester
- Investigators
- Todd Bishop, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032636
- Sponsor's protocol ID
- STUDY00009623
- Status last verified
- Jun 2026
- First submitted
- 27 May 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Crises and Suicide Within the Idaho Army National Guard - Enhancement of the First Line Leader Program
- ClinicalTrials.gov ID
- NCT07032636
- Acronym / sponsor ID
- STUDY00009623
- Conditions
- Crisis Response Plan, Crisis Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Idaho Army National Guard
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Military suicide is an ongoing public health concern, particularly within the Army National Guard (ARNG), with longstanding effects on fellow soldiers, family, and friends. The straddling of military and civilian worlds for ARNG can worsen risk factors for suicide, including increased social isolation, disruption to family life, and employment difficulties. One promising framework that addresses both unit cohesion and social support is the First Line Leaders (FLL) program, recently designated by ARNG for nation-wide dissemination. The program is centered on enhancing the relationship between junior enlisted soldiers (JES) and their assigned non-commissioned officer (NCO). The Investigators propose to study an augmented FLL program that includes templated guides developed in collaboration with Idaho ARNG stakeholders. The guides, referred to as TAP (Total Health Action Plan), were adapted from two empirically based interventions, Crisis Response Planning and Problem-Solving Therapy, and consist of prompts for open communication and effective engagement and guidelines for responding to impending or current behavioral distress. Given their elevated suicide risk, the Idaho ARNG is a crucial setting to develop this upstream intervention.
In this study, the Investigators propose to compare the augmented FLL + TAP program to FLL only, and training as usual (n= 50 NCOs and 100 JES per group) with quarterly assessments for up to one year. The Investigators will examine a random selection of deidentified counseling templates to examine the type and frequency of counseling sessions involving acute crisis and behavioral health difficulties, and online ratings from a random selection of JES using validated instruments to assess upstream indicators of behavioral distress and suicide risk and resilience. The Investigators will also conduct qualitative interviews with a random selection of 20% of the NCOs (n = 30) and JES (n = 60) enrolled in the project to provide personalized perspectives of program experiences.
The Investigators propose three aims to guide this research. (1) Collaborate with Idaho ARNG stakeholders to integrate TAP into FLL programming via: a) development and refinement of TAP training materials, b) building templated counseling statements that align with FLL and TAP, and c) education of Idaho ARNG training cadre in the delivery of TAP. (2) Evaluate fidelity, feasibility, and acceptability of FLL and FLL + TAP through a mixed methods approach of qualitative interviews with FLLs and JESs and evaluation of data from templated counseling sessions. (3) Examine the impact of FLL+TAP versus FLL versus training as usual on unit morale, cohesion, and general functioning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FLL + TAP | Active comparator | Behavioral: Crisis Intervention - The First Line Leaders (FLL) program will utilize templated guides developed with stakeholders from the Idaho Army National Guard (ARNG), known as the Total Health Action Plan (TThis will be a 1-day initial training that incorporates 12 leadership meetings, delivered during monthly drill weekends, and the FLLs will discuss program feasibility and acceptability with the program leadership. In addition to the standard FLL training, this group will learn about the Total Health Action Plan (TAP) and how to deploy it with their soldiers. The Investigators will measure fidelity of TAP delivery, soldier engagement and satisfaction rates, and whether NCOs are more responsive to soldiers reporting problems. |
| FLL | Active comparator | Behavioral: Crisis Intervention - The First Line Leaders (FLL) program will utilize templated guides developed with stakeholders from the Idaho Army National Guard (ARNG), known as the Total Health Action Plan (TThis is the existing 1-day initial training that incorporates 12 leadership meetings, delivered during monthly drill weekends currently being delivered by the Idaho Army National Guard. FLLs will discuss program feasibility and acceptability with the program leadership. |
| No FLL | No intervention | –Participants assigned to this condition will receive training as usual and have not been assigned FLL training by the Idaho Army National Guard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enlistment or commission in the Idaho ARNG at the time of enrollment
- Age 18 or greater
- Ability to complete all study questionnaires and interview procedures
- Has at least one year remaining on National Guard contract
Key exclusion criteria (1 listed)
- Less than one year remaining on their contract with the National Guard
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 |
|---|---|---|
| Crisis Intervention - The First Line Leaders (FLL) program will utilize templated guides developed with stakeholders from the Idaho Army National Guard (ARNG), known as the Total Health Action Plan (TThe Investigators are developing training programs for soldiers and leaders to enhance their communication skills, problem-solving abilities, and approachability. They will be randomized to one of three different groups. | Behavioural | FLL, FLL + TAP |
Primary outcome
Mean change in Fidelity to TAP.
Time frame: Baseline, Month 3, Month 6, Month 9, and, Month 12.
Fidelity to TAP will be assessed by examining counseling statements where an intervention was completed on the templated counseling statement forms generated by our Stakeholder Advisory Board (SAB) using a Likert-type scale (e.g., 1 = poor fidelity, 5 = excellent fidelity). The total range of possible scores is from 1 to 5, with higher scores indicating better fidelity.
Estimate of TAP usage at Follow-Up Assessments
Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12
Participants will be asked to complete a survey item assessing how many times they used a TAP during the 3-, 6-, 9-, and 12-month follow-up visits. Response options will range from 0 to 99. The higher the score, the more TAPs the participant estimates they used during the given assessment period.
Mean satisfaction with TAP while in the FLL training program
Time frame: Baseline, Month 3, Month 6, Month 9, and, Month 12
Participants will be asked to complete a survey called Client Satisfaction Questionnaire (CSQ). CSQ items are rated on a Likert-type scale that ranges from 0 to 4, with the higher total score indicating greater satisfaction with the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- 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.
Todd Bishop, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crisis Intervention - The First Line Leaders (FLL) program will utilize templated guides developed with stakeholders from the Idaho Army National Guard (ARNG), known as the Total Health Action Plan (T in people with Crisis Response Plan and Crisis Intervention, run by University of Rochester at 1 site 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alicia Study Coordinator, BS (585-629-0487, alicia_papalia@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Fidelity to TAP. (time frame: Baseline, Month 3, Month 6, Month 9, and, Month 12.). 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 26 Jun 2026.