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

Mental Illness Clinical Trial

— START-VET  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04366531
• Other study ID #: D3225-R
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: August 2, 2024

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: April Crawford, MS
• Phone: (214) 857-2571
• Email: april.crawford[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2, 2024
• Est. primary completion date: August 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness
• Recently Incarcerated
• Substance Use Disorder
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.