Successful Transitions and Reintegration Tools for Veterans (START-VETS) (START-VET)
Primary Purpose
Substance Use Disorder, Mental Illness, Recently Incarcerated
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
START-VET
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorder focused on measuring reentry, Mental illness, prison, substance use disorder
Eligibility Criteria
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
Sites / Locations
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Monitoring/Treatment as usual
Reentry Program
Arm Description
Veterans will not receive any study related interventions.
Veterans will receive the START-VET reentry program
Outcomes
Primary Outcome Measures
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.
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04366531
First Posted
April 22, 2020
Last Updated
November 9, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04366531
Brief Title
Successful Transitions and Reintegration Tools for Veterans (START-VETS)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
August 2, 2024 (Anticipated)
Study Completion Date
August 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will develop prison reentry materials for Veterans leaving prison.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder, Mental Illness, Recently Incarcerated
Keywords
reentry, Mental illness, prison, substance use disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monitoring/Treatment as usual
Arm Type
No Intervention
Arm Description
Veterans will not receive any study related interventions.
Arm Title
Reentry Program
Arm Type
Active Comparator
Arm Description
Veterans will receive the START-VET reentry program
Intervention Type
Behavioral
Intervention Name(s)
START-VET
Intervention Description
prison reentry program
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
This intervention involves no additional services above what is provided by the local health care system
Primary Outcome Measure Information:
Title
Change in the Brief Symptom Inventory -18
Description
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.
Title
Change in the World Health Organization Quality of Life 100
Description
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.
Title
Inventory of Criminal Thinking Style
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
April Crawford, MS
Phone
(214) 857-2571
Email
april.crawford@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
James P LePage, PhD
Phone
(214) 857-0240
Ext
70240
Email
James.LePage@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James P. LePage, PhD
Organizational Affiliation
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James P LePage, PhD
Phone
214-857-0240
Ext
70240
Email
James.LePage@va.gov
First Name & Middle Initial & Last Name & Degree
James P. LePage, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Successful Transitions and Reintegration Tools for Veterans (START-VETS)
We'll reach out to this number within 24 hrs