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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT04366531
Collaborator
(none)
60
1
2
48
1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: START-VET
  • Other: Treatment as usual
N/A

Detailed Description

This study will be conducted in three phases Phase 1is 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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development of a Psycho-social Transition Program and Transition Assessment Tools for Veterans With Mental Illness and/or Substance Use Disorders Leaving Prison
Actual Study Start Date :
Aug 3, 2020
Anticipated Primary Completion Date :
Aug 2, 2024
Anticipated Study Completion Date :
Aug 2, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in the Brief Symptom Inventory -18 [The Brief Symptom Inventory will be administered at the baseline of the subject's participation and again every 4 weeks for 16 weeks.]

    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.

  2. Change in the World Health Organization Quality of Life 100 [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.]

    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.

  3. Inventory of Criminal Thinking Style [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.]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • psychosis or cognitive impairment precluding active participation

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Dallas Texas United States 75216

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT04366531
Other Study ID Numbers:
  • D3225-R
First Posted:
Apr 29, 2020
Last Update Posted:
Dec 13, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2021