NCT07032636

Brief 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 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.

Trial Health

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Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

May 27, 2025

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline, Month 3, Month 6, Month 9, and, Month 12

Study Arms (3)

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.

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.

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.

Interventions

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.

FLLFLL + TAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Less than one year remaining on their contract with the National Guard

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Idaho Army National Guard

Boise, Idaho, 83716, United States

Location

Study Officials

  • Todd Bishop, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Study Coordinator, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor- Department of Psychiatry

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 24, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations