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Telephone Coaching of Family Members of Veterans With Substance Abuse Problems (Coaching CRAFT)

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ClinicalTrials.gov Identifier: NCT03246646
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Substance Abuse Behavioral: Coaching Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The intervention will be 10-15, 30-45 min. telephone sessions, every 2-3 weeks, with a target number ~12 and will last between 4 and 6 months. The Coach will introduce the ideas behind the content of each VA-CRAFT website module with the CSO, give the CSO an opportunity to view and read the content, and then discuss and individualize/ personalize the content in the next telephone conversation. The VA-CRAFT course for substance misuse has 8 modules that follow the original CRAFT intervention: 1) Introduction to CRAFT, 2) Overview of CRAFT, 3) Getting Started with CRAFT: Safety Planning, 4) Understanding substance abuse, 5) How to respond to substance abuse, 6) How to rebuild your life together, 7) How to help 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Telephone Coaching of Family Members of Veterans With Substance Abuse Problems
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: Coaching
Telephone coaching along with web-based CRAFT course
Behavioral: Coaching
Telephone coaching along with web-based CRAFT course




Primary Outcome Measures :
  1. Veteran's engagement in mental health care [ Time Frame: At any point during study involvement, up to 1 year after enrollment ]
    Veteran's mental health care engagement will be assessed from participant report and/or data pulled from VINCI.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246646


Contacts
Contact: Christina B Babusci (215) 823-6343 Christina.Babusci@va.gov
Contact: Catherine G Conroy, MEd (215) 898-2512 catherine.conroy@va.gov

Locations
United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Steven L Sayers, PhD    215-823-5196    steven.sayers@va.gov   
Principal Investigator: Steven L. Sayers, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Steven L. Sayers, PhD Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03246646     History of Changes
Other Study ID Numbers: D2070-P
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Substance Abuse
Alcohol Abuse

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders