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Clinical Trials/NCT04366531
NCT04366531RecruitingNot Applicable

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

VA Office of Research and Development1 site in 1 country20 target enrollmentStarted: August 3, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
Change in the Brief Symptom Inventory -18

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

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

Intervention: START-VET (Behavioral)

Reentry Program

Active Comparator

Veterans will receive the START-VET reentry program

Intervention: Treatment as usual (Other)

Outcomes

Primary Outcomes

Change in the Brief Symptom Inventory -18

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.

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.

Inventory of Criminal Thinking Style

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.

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

Change in the World Health Organization Quality of Life 100

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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