Veteran Sponsorship Program for Reintegration Difficulties

Recruiting at 2 trial locations

Overseen By Marianne S Goodman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

630 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young Veterans transition smoothly to civilian life and reduce suicide risk by pairing them with certified and volunteer sponsors through the TSMV Sponsorship Initiative. The focus is on easing reintegration difficulties and boosting connectedness for Veterans leaving the military. Participants will either receive this sponsorship support or transition as usual without it. Veterans about six months from military discharge who plan to move to one of the target cities in Texas are well-suited for this trial. The results will determine the initiative's effectiveness and guide its future expansion.

As an unphased trial, this study offers Veterans a unique opportunity to contribute to research that could significantly improve the transition experience for future service members.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Veteran Sponsorship Initiative is safe for Veterans?

Research shows that community programs like the Veteran Sponsorship Initiative can greatly assist veterans transitioning to civilian life. This program pairs veterans with sponsors who offer personalized support. Studies have found that similar programs can ease emotional pain and aid adjustment, potentially reducing the risk of suicide.

Regarding safety, joining this type of community support program poses no direct risk. The initiative employs trained volunteers and certified sponsors, ensuring veterans receive help from those who understand their needs. Without involving medical treatment, the focus remains on emotional and social support, which is generally safe and well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Veteran Sponsorship Initiative because it provides personalized support tailored to each veteran's unique needs as they transition back to civilian life. Unlike traditional methods that often leave veterans to navigate this challenging period on their own, this initiative pairs them with a VA-certified sponsor who offers one-on-one guidance and support for about a year. This approach aims to ease reintegration stress and improve outcomes by fostering a supportive relationship that begins months before discharge and continues well after, potentially leading to more successful transitions compared to the usual process.

What evidence suggests that the Veteran Sponsorship Initiative is effective for reintegration difficulties?

Research has shown that community programs can greatly assist Veterans transitioning to civilian life. In this trial, the Veteran Sponsorship Initiative connects Veterans with sponsors to help ease challenges like feeling disconnected or stressed. Early results suggest this method effectively reduces these issues and boosts overall well-being. Studies indicate that having a sponsor can also lessen feelings of isolation and distress, potentially lowering the risk of suicidal thoughts and actions. This program creates a support network, which is vital for Veterans adjusting to life after military service. ^{1 2 4 5 6}

Who Is on the Research Team?

Joseph C Geraci, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

This trial is for US Veterans aged 18-34 transitioning to civilian life, who are within six months of being discharged and planning to move to one of the target cities in Texas. It aims to help them with reintegration difficulties and reduce suicidal thoughts by pairing them with sponsors.

Inclusion Criteria

You are not planning to move to one of the cities being studied during the enrollment period.

You must have been discharged from military service at least 6 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Discharge Sponsorship

TSMVs receive a VA certified and volunteer sponsor approximately 6 months prior to military discharge.

6 months

Regular virtual check-ins

Post-Discharge Sponsorship

Sponsorship continues for approximately 6 months after military discharge to assist with reintegration.

6 months

Regular virtual check-ins

Follow-up

Participants are monitored for reintegration difficulties, connectedness, and mental health outcomes.

12 months

Surveys and interviews at 4, 8, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• TSMV Sponsorship Initiative

Trial Overview The TSMV Sponsorship Initiative is being tested for its effectiveness in easing the transition from military service by reducing reintegration challenges, improving health, connectedness, and lowering suicide risks among young Veterans.

How Is the Trial Designed?

Group I: Veteran Sponsorship Initiative Experimental Treatment 1 Intervention

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.

Group II: Transition as Usual Active Control 1 Intervention

TSMVs transition to civilian life as usual.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Central Texas Veterans Health Care System

Collaborator

Trials

5

Recruited

1,300+

Published Research Related to This Trial

A review of 186 articles on the reintegration of military service members and veterans (MSMVs) highlighted a significant lack of clear definitions and comprehensive theories regarding their reintegration challenges, indicating a need for more structured research.

The study identified various challenges at individual, interpersonal, community, and societal levels, and recommended using an ecological model to improve research and practices aimed at facilitating MSMV reintegration, as most existing studies did not adequately consider the broader context of these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military service member and veteran reintegration: A critical review and adapted ecological model. Elnitsky, CA., Blevins, CL., Fisher, MP., et al.[2018]

Dog training programs can positively impact the mental health and well-being of military veterans, helping them reintegrate into civilian life by providing social benefits and a sense of purpose.

However, the review also highlighted potential negative outcomes related to the stressful demands of training, indicating the need for further research to optimize these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dog training as a complementary intervention to support Veteran mental health and well-being: A scoping review. Van Buiten, H., Flynn, E., Morris, KN.[2021]

In a study involving 68 heroin-dependent subjects over 26 weeks, health data linkage revealed that a significant number of serious adverse events (SAEs) went unreported by participants, with 41.4% of hospital admissions and 67.7% of emergency department visits not documented in the trial.

The use of health data linkage resulted in a substantial increase in recorded SAEs, showing a 1.71-fold increase in hospital admissions and a 3.09-fold increase in emergency department attendances, highlighting its effectiveness in capturing missing health data in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the usefulness of health data linkage in obtaining adverse event data in a randomised controlled trial of oral and implant naltrexone in the treatment of heroin dependence. Kelty, E., Ngo, H., Hulse, G.[2013]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

Post-marketing surveillance (PMS) of drugs can effectively utilize Medicaid data, which tracks drug exposures and associated events, to enhance drug safety monitoring.

Studies using data from Michigan and Minnesota, involving 1.5 million patients over 18 months, indicate that this data can be a valuable resource for identifying drug risks and supporting hypotheses about drug-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medicaid drug-event data: an emerging tool for evaluation of drug risk. Jones, JK., Van de Carr, SW., Rosa, F., et al.[2019]

A randomized controlled trial involving 200 transitioning servicemembers and veterans found that community-based interventions alone did not significantly improve reintegration difficulties or social support compared to a waitlist group.

However, the combination of the Team Red, White, and Blue program with the Expiration Term of Service Sponsorship Program showed better outcomes, indicating that having one-on-one support during reintegration can enhance the effectiveness of community activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting servicemembers and veterans during their transition to civilian life using certified sponsors: A three-arm randomized controlled trial. Geraci, JC., Dichiara, A., Greene, A., et al.[2023]

Approximately 25% to 56% of Iraq and Afghanistan combat veterans receiving VA care reported significant difficulties in areas like social functioning and self-care, highlighting the need for targeted reintegration support.

A strong interest (96%) in services to aid readjustment to civilian life was noted, especially among veterans screening positive for probable PTSD, indicating a demand for effective intervention strategies, including online resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reintegration problems and treatment interests among Iraq and Afghanistan combat veterans receiving VA medical care. Sayer, NA., Noorbaloochi, S., Frazier, P., et al.[2022]

The Tribal Veterans Representative (TVR) program effectively addresses the underutilization of VA services among American Indian and Alaska Native Veterans by providing community-based outreach and support, resulting in countless enrollments and improved access to care.

The program has led to the establishment of additional resources such as Telemental Health Clinics for PTSD treatment and transportation services, demonstrating its comprehensive approach to enhancing Veterans' healthcare access in rural and remote areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tribal Veterans Representative (TVR) training program: the effect of community outreach workers on American Indian and Alaska Native Veterans access to and utilization of the Veterans Health Administration. Kaufmann, LJ., Buck Richardson, WJ., Floyd, J., et al.[2022]

The Aggregate Safety Assessment Plan (ASAP) is designed to enhance safety planning and ongoing data review throughout a drug's life-cycle, promoting a systematic approach to understanding product safety.

By implementing the ASAP process, drug developers can improve early detection of safety signals, better characterize risks, and ensure consistent safety messaging across studies, ultimately aiding in informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle. Hendrickson, BA., Wang, W., Ball, G., et al.[2021]

A postmarket surveillance program involving 9907 patients confirmed that cimetidine has a low incidence of adverse effects (4.4% in phase I and 1.8% in phase II), consistent with premarket studies.

The study demonstrated that the types of adverse effects reported were similar to those found in earlier clinical trials, reinforcing the safety profile of cimetidine over a follow-up period of up to 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A unique postmarket outpatient surveillance program of cimetidine: report on phase II and final summary. Humphries, TJ., Myerson, RM., Gifford, LM., et al.[2013]

Strong social support, impactful programs, and protective personal beliefs were identified as key facilitators that help injured female veterans reintegrate into the community, based on interviews with 13 participants.

Barriers to community reintegration included inadequate services, lack of access, poor social support, and personal beliefs, with many challenges being uniquely influenced by the participants' experiences as women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contextual Facilitators and Barriers of Community Reintegration Among Injured Female Military Veterans: A Qualitative Study. Hawkins, BL., Crowe, BM.[2019]

In a study of 496 veterans with severe substance use disorders, 65% reported no substance use three months after completing a residential-work therapy program, indicating significant treatment efficacy.

The study found that more intensive treatment elements, such as frequent toxicology screenings and longer stays, were associated with better outcomes, supporting the effectiveness of combining residential support with accountability in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of treatment elements in a residential-work therapy program for veterans with severe substance abuse. Rosenheck, R., Seibyl, CL.[2019]

The Veterans' In-home Programme (VIP) significantly improved community re-integration scores and reduced difficulties in managing specific symptoms for veterans with traumatic brain injury (TBI) compared to a control group, based on a study involving 81 participants.

The VIP was well-accepted by participants and highlights the potential of home-based, family-inclusive interventions to enhance the quality of life for veterans with TBI, suggesting a need for further research and clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and acceptability of a home-based, family-inclusive intervention for veterans with TBI: A randomized controlled trial. Winter, L., Moriarty, HJ., Robinson, K., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10755060/

Supporting Service Members and Veterans During Transition ... Various efforts have been implemented to support TSMV reintegrate into civilian life more successfully. For example, more than 27,000 non-profit, community- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05224440

National Sponsorship Program for Transitioning Service ... To test the primary hypothesis, that the Sponsorship Initiative reduces reintegration difficulties (as assessed by the M2C-Q) with power of 80%, alpha of .

3. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-022-01212-9

Partnered implementation of the veteran sponsorship initiative The purpose of this randomized hybrid type 2 effectiveness-implementation trial is to evaluate the implementation of the VSI in six cities in Texas.

4. escholarship.org escholarship.org/content/qt4980g6vc/qt4980g6vc.pdf

Partnered implementation of the veteran sponsorship ... The first aim of this evaluation is to assess the effectiveness of the VSI in improving proxi- mal (reintegration difficulties, health/ ...

5. mirecc.va.gov mirecc.va.gov/visn17/vsi/research.asp

Veteran Sponsorship Initiative Resources for active duty servicemembers who are transitioning to civilian life.

6. news.va.gov news.va.gov/130151/peer-sponsorshipsuccess-civilian-transition/

Peer sponsorship increases success of military-to-civilian ... Peer sponsorship increases success of military-to-civilian transition · Over 1,000 risk-assessment screenings each month · “Finding the program ...