Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT04366531

Conditions

Substance Use Disorder

Mental Illness

Recently Incarcerated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

START-VET

Treatment as usual

Study Details

Brief summary:

This study will develop prison reentry materials for Veterans leaving prison.

Conditions

Substance Use Disorder

Mental Illness

Recently Incarcerated

Study ID

NCT04366531

Start date

Aug 3, 2020

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 2, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Veteran with mental illness and/or substance use disorder released from prison within the past 36 months

Exclusion Criteria:

  • psychosis or cognitive impairment precluding active participation

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Monitoring/Treatment as usual

Veterans will not receive any study related interventions.

active comparator: Reentry Program

Veterans will receive the START-VET reentry program

Interventions

START-VET

prison reentry program

Treatment as usual

This intervention involves no additional services above what is provided by the local health care system

Primary outcome measure

  • Change in the Brief Symptom Inventory -18 [ Time Frame: The Brief Symptom Inventory will be administered at the baseline of the subject's participation and again every 4 weeks for 16 weeks. ]
  • Change in the World Health Organization Quality of Life 100 [ Time Frame: The World Health Organization Quality of Live 100 will be administered at the baseline of the subject's participation and again every 4 weeks for 16 weeks. ]
  • Inventory of Criminal Thinking Style [ Time Frame: The Inventory of Criminal Thinking Style will be administered at the baseline of the subject's participation and again every 4 weeks for 16 weeks. ]

Central Contacts and Locations

Central contacts

April Crawford, MS

(214) 857-2571april.crawford@va.gov

Locations

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Recruiting

Dallas, Texas, United States, 75216-7167

Contacts

April Crawford, MS

214-857-2571april.crawford@va.gov

Principal Investigator:

James P. LePage, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

  • reentry
  • Mental illness
  • prison
  • substance use disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-09-26.