CClinicalTrials.gg
RecruitingNCT04366531START-VETUpdated Sep 29, 2026

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

An interventional study of START-VET and Treatment as usual in Substance Use Disorder, Mental Illness and Recently Incarcerated, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Substance Use Disorder
  • Mental Illness
  • Recently Incarcerated

Keywords

  • reentry
  • Mental illness
  • prison
  • substance use disorder
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Psychosis or cognitive impairment precluding active participation
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study 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

    Behavioral: START-VET · Other: Treatment as usual

Interventions

  • BehavioralSTART-VET

    prison reentry program

  • OtherTreatment as usual

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

05

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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

    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.

06

Study locations

1 of 1 sites recruiting
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
    Dallas, Texas 75216-7167, United States
    • April Crawford, MS · Contact · april.crawford@va.gov · (214) 857-2571
    • James P. LePage, PhD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04366531
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Apr 29, 2020
Start date
Aug 3, 2020
Primary completion
Oct 2, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 29, 2026

Study contacts

April Crawford, MS
Contact
april.crawford@va.gov
(214) 857-2571
James P. LePage, PhD
principal investigator · VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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