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

NCT04366531 | Recruiting

• 1 other identifier: D3225-R
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Substance Use Disorder; Mental Illness; Recently Incarcerated

Keywords

reentry; Mental illness; prison; substance use disorder

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Monitoring/Treatment as usual

NO INTERVENTION

Veterans will not receive any study related interventions.

Reentry Program

ACTIVE COMPARATOR

Veterans will receive the START-VET reentry program

Behavioral: START-VET; Other: Treatment as usual

Interventions

START-VET BEHAVIORAL

prison reentry program

Reentry Program

Treatment as usual OTHER

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

Reentry Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• psychosis or cognitive impairment precluding active participation

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Dallas, Texas, 75216-7167, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Mental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• James P. LePage, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

April Crawford, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Veterans will be randomly assigned to either begin an eight week (actual number of weeks is to be determined based on phase 2) active treatment program or to a no treatment phase. At eight weeks veterans will switch the condition they were assigned.

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 29, 2020
• Study Start: August 3, 2020
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)