NCT05224440

Brief Summary

Background: The United States is undergoing a suicide epidemic for its youngest Veterans (18-to-34-years-old) as their suicide rate has almost doubled since 2001. Veterans are at the highest risk during their first-year post-discharge, thus creating a "deadly gap" for them. In response, the nation has developed strategies that emphasize a preventive, universal and public health approach and embrace the value of community interventions. The three-step theory of suicide suggests that community interventions that reduce pain from reintegration difficulties and promote connectedness for Veterans as they transition to civilian life have the greatest likelihood of success. Recent research shows that the effectiveness of community interventions can be enhanced when augmented by volunteer and certified sponsors (1-on-1) who actively engage with Veterans, as part of the Veterans Affairs' Transitioning Servicemember/Veteran (TSMV) Sponsorship Initiative. Method/Design: The purpose of this trial is to determine how to implement the Veteran Sponsorship Initiative in six cities in Texas in collaboration with the US Department of Defense, VA, Texas government, and local stakeholders. Texas is an optimal location for this large-scale implementation as it has the second largest population of Veterans aged 18-to-34-years-old and is home to the largest US military installation, Fort Hood. The first aim is to further determine the effectiveness of the Sponsorship Initiative, as evidenced by measures of proximal variables (reintegration difficulties, health/psychological distress, VA healthcare utilization and connectedness) and distal variables (suicidal ideation and behaviors). The second aim is to determine how best to implement the Veteran Sponsorship Initiative in Texas with the intent of future expansion in more states. TSMVs (n=630) will be recruited from military installations six months prior to discharge and prior to moving to target cities. The evaluators are utilizing implementation strategies, such as building community partnerships and external facilitation. Evaluation will be conducted through interviews with TSMVs and periodic reflections with key stakeholders to identify barriers, facilitators, and adaptations. Outcome evaluations will be conducted with TSMVs completing surveys and data collection from working with stakeholders. Discussion: This evaluation will have important implications for the national implementation of community interventions that address the epidemic of TSMV suicide. Aligned with the Evidence Act, it is the first large-scale implementation of an evidence-based practice that conducts a thorough assessment of TSMVs during the "deadly gap".

Trial Health

77
On Track

Trial Health Score

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

Enrollment
630

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2022Sep 2026

First Submitted

Initial submission to the registry

January 10, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 4, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

4.7 years

First QC Date

January 10, 2022

Last Update Submit

January 13, 2026

Conditions

Keywords

Reintegration difficultiesTransitioning Servicemember/VeteranVeteran Sponsorship InitiativeConnectednessSuicide preventionVA UtilizationCommunity interventionStepped Wedge

Outcome Measures

Primary Outcomes (1)

  • Military to Civilian Questionnaire (M2C-Q; Sayer et al., 2011)

    Reintegration difficulties will be assessed using the Military to Civilian Questionnaire (Primary Outcome; M2C-Q; Sayer et al., 2011), a 16-item measure that assesses reintegration difficulties in (a) interpersonal relationships with family, friends, and peers; (b) productivity at work, in school, or at home, (c) community participation; (d) self-care; (e) leisure, and (f) perceived meaning in life. Items are rated on a 5-point Likert scale ranging from 0 (No difficulty) to 4 (Extreme difficulty). Minimum: 0 (best); Maximum: 4 (worst)

    Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after]

Secondary Outcomes (25)

  • Employment/education status

    Change in baseline scores across 4 timepoints [ Time Frame: Baseline, 4 months after, 8 months after, 12 months after]

  • Brief Resilience Scale (BRS; Smith et al., 2008)

    Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after]

  • VA Homelessness Screening Clinical Reminder (HSCR; Montgomery, 2014)

    Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after]

  • U.S. Adult Food Security Survey Module (2012)

    Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after]

  • Criminal behaviors

    Change in baseline scores across 2 timepoints [ Time Frame: Baseline and 12 months after]

  • +20 more secondary outcomes

Study Arms (2)

Veteran Sponsorship Initiative

EXPERIMENTAL

TSMV receives a VA certified and volunteer sponsor (1-on-1) approximately 6 months prior to military discharge. Sponsorship continues for approximately 6 months after military discharge.

Behavioral: Veteran Sponsorship Initiative

Transition as Usual

NO INTERVENTION

TSMVs transition to civilian life as usual.

Interventions

Consistent with preventive, universal and public health approaches to suicide, the VA's TSMV Sponsorship Initiative establishes public-private partnerships with federal and community organizations to provide TSMVs with one-on-one, certified and volunteer sponsors in their post-military hometowns. Sponsors are assigned approximately six months prior to discharge and help TSMVs to accomplish reintegration tasks pre-and post-discharge. After certification, sponsors are assigned to and managed by a community integration coordinator (CIC), which is a local organization. CICs recruit sponsors, manage sponsors and match sponsors with TSMVs moving to the local region. After being matched with a TSMV, sponsors then integrate their skills during regular contact with matched TSMVs and monthly video or in-person sessions and help TSMVs identify SMART goals and develop reintegration action plans and ensure TSMVs attend VA healthcare appointments.

Veteran Sponsorship Initiative

Eligibility Criteria

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

You may qualify if:

  • TSMVs must be 18-years of age or older,
  • be approximately 6 months from military discharge and
  • be planning to transition to one of the target cities included in the evaluation during an active enrollment window for the respective city.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

RECRUITING

Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

Waco, Texas, 76711, United States

RECRUITING

Related Publications (1)

  • Geraci JC, Finley EP, Edwards ER, Frankfurt S, Kurz AS, Kamdar N, Vanneman ME, Lopoo LM, Patnaik H, Yoon J, Armstrong N, Greene AL, Cantor G, Wrobleski J, Young E, Goldsmith M, Seim RW, Goodman M. Partnered implementation of the veteran sponsorship initiative: protocol for a randomized hybrid type 2 effectiveness-implementation trial. Implement Sci. 2022 Jul 8;17(1):43. doi: 10.1186/s13012-022-01212-9.

MeSH Terms

Conditions

Suicidal IdeationBehaviorSuicide Prevention

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral Symptoms

Study Officials

  • Joseph C Geraci, PhD

    James J. Peters Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph C Geraci, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: To execute the Hybrid Type 2, we will use a stepped wedge design, which relies on sequential roll-out to participating cities over time. The cities in Texas with the largest population density of veterans were selected. Our design also enables us to make efficient use of all data available for within-site and between-site comparisons. The comparison examines cities as they cross-over from Transition as Usual (TAU) to intervention. The between-site comparison evaluates the intervention period for a city vs. all other intervention and TAU periods for all cities. We randomized at the city level and will use TSMVs as the unit of observation for primary quantitative outcome measures. Six cities are participating in the evaluation, with two cities allocated to each of the three start dates or steps. Because cities differ regarding organizational characteristics, we used the restricted selection method of randomization to balance cities based on the number of projected TSMV moving to target.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2022

First Posted

February 4, 2022

Study Start

February 4, 2022

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations