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Crisis Prevention Enhancement for Idaho Army National Guard

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Study AimThis program is designed for Idaho Army National Guard members to learn and practice Crisis Prevention and Intervention techniques. We will assess the usage, fidelity to the program, and satisfaction levels at follow-up visits.
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

Behavioral
Who is being recruted

Crisis Response Plan

+ Crisis Intervention
Over 18 Years
+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorUniversity of Rochester
Study ContactAlicia Study Coordinator, BS
Last updated: September 8, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2025Actual date on which the first participant was enrolled.

This study aims to address the pressing issue of military suicide, particularly among the Army National Guard (ARNG) members in Idaho. The research focuses on enhancing the First Line Leaders (FLL) program, which is designed to strengthen the bond between junior enlisted soldiers and their non-commissioned officers. By integrating a new component called TAP (Total Health Action Plan), the program seeks to mitigate risk factors like social isolation and employment difficulties that contribute to mental health struggles. The TAP consists of structured guides for open communication and effective engagement, adapted from proven interventions like Crisis Response Planning and Problem-Solving Therapy. This study is crucial for developing strategies to reduce suicide risk and improve the support system within the ARNG. Participants in the study include 50 non-commissioned officers and 100 junior enlisted soldiers per group. The study will compare three groups: the enhanced FLL program with TAP, the FLL program alone, and the usual training. Over the course of a year, participants will undergo regular assessments every three months. Researchers will analyze counseling templates to understand the nature and frequency of sessions dealing with crises and behavioral issues. They will also gather feedback through online ratings and qualitative interviews to evaluate the program's impact on behavioral distress and suicide risk. The study will assess how well the program is implemented and its effect on unit morale and cohesion.

Official TitleReducing Crises and Suicide Within the Idaho Army National Guard - Enhancement of the First Line Leader Program 
Principal SponsorUniversity of Rochester
Study ContactAlicia Study Coordinator, BS
Last updated: September 8, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
450 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Crisis Response Plan
Crisis Intervention
Criteria
4 inclusion criteria required to participate
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
1 exclusion criteria prevent from participating
\- Less than one year remaining on their contract with the National Guard

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.
Group II
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.
Group III
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.
Study Objectives
Primary Objectives

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.

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.

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Idaho Army National GuardBoise, United StatesSee the location
Recruiting soonOne Study Center