Veteran Sponsorship Program for Reintegration Difficulties

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

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".

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 data supports the effectiveness of the TSMV Sponsorship Initiative treatment for reintegration difficulties?

The study found that veterans who participated in the TSMV Sponsorship Initiative, which includes one-on-one support from certified sponsors, experienced fewer reintegration difficulties and initially had more social support compared to those who only participated in community activities. This suggests that having a sponsor can enhance the effectiveness of community-based interventions for veterans. ^{1 2 3 4 5}

Is the Veteran Sponsorship Program for Reintegration Difficulties generally safe for humans?

The available research does not provide specific safety data for the Veteran Sponsorship Program for Reintegration Difficulties or its related initiatives. However, general safety assessment processes like the Aggregate Safety Assessment Plan (ASAP) are used in drug development to ensure ongoing safety evaluation and early detection of potential risks. ^{6 7 8 9 10}

How is the TSMV Sponsorship Initiative treatment different from other treatments for reintegration difficulties?

The TSMV Sponsorship Initiative is unique because it pairs veterans with certified sponsors who provide one-on-one support during their reintegration into civilian life, which is different from other treatments that may not offer personalized guidance. This approach aims to enhance social support and reduce reintegration difficulties by directly addressing the individual needs of veterans. ^{1 4 11 12 13}

Research Team

Joseph C Geraci, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Supporting servicemembers and veterans during their transition to civilian life using certified sponsors: A three-arm randomized controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Reintegration problems and treatment interests among Iraq and Afghanistan combat veterans receiving VA medical care. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and acceptability of a home-based, family-inclusive intervention for veterans with TBI: A randomized controlled trial. [2021]

6. England 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. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle. [2021]

9. Sweden pubmed.ncbi.nlm.nih.gov

Medicaid drug-event data: an emerging tool for evaluation of drug risk. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

A unique postmarket outpatient surveillance program of cimetidine: report on phase II and final summary. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Military service member and veteran reintegration: A critical review and adapted ecological model. [2018]

12. Netherlands 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. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Dog training as a complementary intervention to support Veteran mental health and well-being: A scoping review. [2021]