Telephone Coaching of Family Members of Veterans With Substance Abuse Problems (VA-CRAFT)
Primary Purpose
Substance Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coaching
Sponsored by
About this trial
This is an interventional other trial for Substance Abuse focused on measuring Substance Abuse, Alcohol Abuse
Eligibility Criteria
Inclusion Criteria:
- CSO is a sibling, spouse/ intimate partner, or parent of a US military Veteran who served in Iraq or Afghanistan since 2001
- by the report of the CSO the Veteran of interest has a substance abuse problem that has led to interpersonal, legal, occupational, and/or health related negative consequences
- the CSO reports that the Veteran is not currently receiving treatment for this problem
- the CSO has contact 4+times/week and lives with or within 30 min. of the Veteran.
Exclusion Criteria:
- CSO has a SUD (Form 90, see Measures)
- the Veteran is currently incarcerated
- the CSO has no computer or other device with Internet access able to view video content
- the CSO or Veteran likely has a psychotic disorder (CSO report on the MINI) (see Measures)
- the CSO's involvement in a "coaching" intervention meant to encourage the Veteran to actively consider to seek care places the CSO at risk on a physical or psychological basis
- Callers who do not have access to a safe phone line will not be referred to the study.
Sites / Locations
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Coaching + VA CRAFT
Treatment as usual
Arm Description
Telephone coaching along with web-based CRAFT course
Treatment as usual matched comparison
Outcomes
Primary Outcome Measures
Number of Veteran's Engaged in Mental Health Care
Veteran's mental health care engagement was assessed from CSO participants' report.
Secondary Outcome Measures
Full Information
NCT ID
NCT03246646
First Posted
August 7, 2017
Last Updated
June 9, 2021
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03246646
Brief Title
Telephone Coaching of Family Members of Veterans With Substance Abuse Problems
Acronym
VA-CRAFT
Official Title
Telephone Coaching of Family Members of Veterans With Substance Abuse Problems
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
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 project will develop and pilot test an enhanced, telephone "coaching" intervention to help family members concerned about a Veteran of the wars in Iraq or Afghanistan who needs to seek treatment for a substance abuse problem.
Detailed Description
The investigators will first develop a detailed manual for Coaching-CRAFT, which will be a telephone-based model of coaching that uses the web-version of an intervention already developed and available to the investigators. The investigators will conduct a preliminary nonrandomized feasibility trial of the use of Coaching-CRAFT with a sample of 50 family member callers recruited from VA's Coaching Into Care call center. Later in the study, the investigators will recruit up to 50 Veterans whose family members also participated in this study. Since the 'Coaching Into Care' telephone-based call center located at the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) is a national call center, study subjects (non-Veterans and Veterans) will be from all parts of the United States.
Family members (spouses, siblings, or parents) of Veteran will be recruited from Coaching Into Care, and offered telephone-based coaching to the family member regarding their concern that the Veteran has a substance abuse problem and does not want to seek treatment. The program will involve approximately 12 telephone calls over 4-6 months. Family members will be assessed for their own mental health symptoms, their perception of their Veteran's mental health symptoms and substance use, his or her treatment, as well as their perception of burden on the relationship with the Veteran. These assessments will occur at study entry, 6 months, and 12 months after study entry. Veteran's perceptions of the intervention will be sought at 12 months, whenever safe and practical. For Veterans who are not approached to participate in the study, VHA administrative data will be sought through a HIPAA Waiver to confirm any possible mental health and or substance abuse treatment the Veteran has received. Rates of initiation of treatment will be compared to QA data from the Coaching Into Care call center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Substance Abuse, Alcohol Abuse
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention will be approximately 12, 30-45 min. telephone sessions, every 2-3 weeks, and will last 4-6 months. The Coach helps the participant individualize the content of a web-based course (VA-CRAFT) based on an intervention to encourage a loved one to seek treatment for substance abuse. The VA-CRAFT course has 8 modules that follow the original CRAFT intervention: 1) Introduction, 2) Overview, 3) Getting Started: Safety Planning, 4) Understanding substance abuse, 5) How to respond to substance abuse, 6) Rebuilding your life together, 7) Helping someone consider treatment, 8) Wrapping up. The goals include understanding triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and how to help the CSO caller help the Veteran enter treatment. The participants in the active intervention will be compared to a treatment as usual, matched comparator group drawn from regular clinical operations.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coaching + VA CRAFT
Arm Type
Experimental
Arm Description
Telephone coaching along with web-based CRAFT course
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
Treatment as usual matched comparison
Intervention Type
Behavioral
Intervention Name(s)
Coaching
Intervention Description
Telephone coaching was provided in a series of telephone based sessions with CSO participants
Primary Outcome Measure Information:
Title
Number of Veteran's Engaged in Mental Health Care
Description
Veteran's mental health care engagement was assessed from CSO participants' report.
Time Frame
At any point during study involvement, up to 1 year after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CSO is a sibling, spouse/ intimate partner, or parent of a US military Veteran who served in Iraq or Afghanistan since 2001
by the report of the CSO the Veteran of interest has a substance abuse problem that has led to interpersonal, legal, occupational, and/or health related negative consequences
the CSO reports that the Veteran is not currently receiving treatment for this problem
the CSO has contact 4+times/week and lives with or within 30 min. of the Veteran.
Exclusion Criteria:
CSO has a SUD (Form 90, see Measures)
the Veteran is currently incarcerated
the CSO has no computer or other device with Internet access able to view video content
the CSO or Veteran likely has a psychotic disorder (CSO report on the MINI) (see Measures)
the CSO's involvement in a "coaching" intervention meant to encourage the Veteran to actively consider to seek care places the CSO at risk on a physical or psychological basis
Callers who do not have access to a safe phone line will not be referred to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L. Sayers, PhD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Telephone Coaching of Family Members of Veterans With Substance Abuse Problems
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