Successful Transitions and Reintegration Tools for Veterans (START-VETS) (START-VET)

Development of a Psycho-social Transition Program and Transition Assessment Tools for Veterans With Mental Illness and/or Substance Use Disorders Leaving Prison

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

Study Overview

• Status: Recruiting
• Conditions: Substance Use Disorder; Mental Illness; Recently Incarcerated
• Intervention / Treatment: Behavioral: START-VET; Other: Treatment as usual

Detailed Description

This study will be conducted in three phases Phase 1 is to collect qualitative data from Veterans who have recently been released from prison. The data will focus on their transition experience, stigma (both self and from others), and behaviors that interfered with success.

Phase 2a will be to develop a transition program based around the needs identified in phase 1 Phase 2b will be to develop assessment tools to be used with the program Phase 3 will be to perform a two group randomized cross over design pilot study to assess the program

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: April Crawford, MS; Phone Number: (214) 857-2571; Email: april.crawford@va.gov

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75216-7167
      • Recruiting
      • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
      • Principal Investigator: James P. LePage, PhD
      • Contact: April Crawford, MS; Phone Number: 214-857-2571; Email: april.crawford@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: START-VET; prison reentry program; Other: Treatment as usual; This intervention involves no additional services above what is provided by the local health care system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Brief Symptom Inventory -18	The Brief Symptom Inventory - 18 evaluates the domains of Somatization, Depression, and Anxiety. Each scale has 6 items, with a range of 0-24. Higher indicates a higher amount of the identified construct, i.e a worse outcome.	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	The World Health Organization Quality of Life 100 is a overall measure quality of life for participants. It has 5 domains: Physical (12 items, range 12-60), Psychological (18 items, range 18-90), Independence (16 items, range 16 - 80), Social (12 items, range 12-60), Environment (32 items, range 32-160), and Spiritual (4 items, range 4-20). Higher indicates higher levels of quality of life.	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	The Inventory of Criminal Thinking Styles (PICTS) is an 80-item self-report inventory designed to measure eight thinking styles presumed to reinforce, support, and maintain a criminal lifestyle. The eight thinking styles assessed by the PICTS are Mollification, Cutoff, Entitlement, Power Orientation, Superoptimism, Sentimentality, Cognitive Indolence, and Discontinuity. There are 10 items on each scale with scale scores ranging from 0 - 30. Higher indicates worse outcomes	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.

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: James P. LePage, PhD, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: substance use disorder; Mental illness; prison; reentry
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Mental Disorders; Therapeutics
• Other Study ID Numbers: D3225-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No