Trial Outcomes & Findings for Telephone Coaching of Family Members of Veterans With Substance Abuse Problems (NCT NCT03246646)

NCT ID: NCT03246646

Last Updated: 2021-06-30

Results Overview

Veteran's mental health care engagement was assessed from CSO participants' report.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

At any point during study involvement, up to 1 year after enrollment

Results posted on

2021-06-30

Participant Flow

Potential participants were recruited from the callers who reached a staff member of the Coaching Into Care (CIC) program. Those interested in considering the research study were screened by a study staff member, consented if eligible, and given a baseline assessment. Some participants responded to notices on social media who filled out a brief online screener or contact study staff directly. The matched TAU control participants were selected from callers to CIC in the same time period.

Participant milestones

Participant milestones
Measure	Coaching + VA-CRAFT The interventionist provided a telephone-guided coaching intervention with the aid of a web-based program, VA-CRAFT, developed by the Co-Investigators for concerned significant others (CSOs). The VA-CRAFT program, based on the original Community Reinforcement and Family Training (CRAFT) program for substance misuse has 8 modules: 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 of the intervention include helping the CSO understand triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and encouraging the Veteran to enter mental health treatment for substance abuse. After viewing each of the VA-CRAFT web-based modules, the interventionist reviewed and personalized the material with the CSO via a telephone conversation. The intervention was flexible within the following framework: 1) 8 to 12, 30-45 min. telephone sessions, every 2-3 weeks, and 2) between 4 and 6 months.	Treatment as Usual (TAU) Coaching The treatment as usual coaching (TAU) seeks to empower, motivate, educate, and improved the concerned significant others' (CSOs') listening and communication skills with the goal of enhancing the veteran's intrinsic motivation for care. It draws from self-determination theory and emphasizes humans' underlying need for autonomy to maximize intrinsic motivation. CSOs were encouraged to reduce their pressure on the veteran to seek care and to engage in more positive activities of interest to both. CSOs were coached to listen for concerns expressed by the veteran, such as complaints about mood, anxiety, or the future (11, 12). CSOs were also encouraged to use an "autonomy-supportive" style of communication, which means offering to help the veteran but stating that it is understood that the offer is subject to the veteran welcoming this assistance. Coaching includes behavioral rehearsal to enhance the learning of these skills.
Overall Study STARTED	26	26
Overall Study COMPLETED	15	26
Overall Study NOT COMPLETED	11	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Coaching + VA-CRAFT The interventionist provided a telephone-guided coaching intervention with the aid of a web-based program, VA-CRAFT, developed by the Co-Investigators for concerned significant others (CSOs). The VA-CRAFT program, based on the original Community Reinforcement and Family Training (CRAFT) program for substance misuse has 8 modules: 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 of the intervention include helping the CSO understand triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and encouraging the Veteran to enter mental health treatment for substance abuse. After viewing each of the VA-CRAFT web-based modules, the interventionist reviewed and personalized the material with the CSO via a telephone conversation. The intervention was flexible within the following framework: 1) 8 to 12, 30-45 min. telephone sessions, every 2-3 weeks, and 2) between 4 and 6 months.	Treatment as Usual (TAU) Coaching The treatment as usual coaching (TAU) seeks to empower, motivate, educate, and improved the concerned significant others' (CSOs') listening and communication skills with the goal of enhancing the veteran's intrinsic motivation for care. It draws from self-determination theory and emphasizes humans' underlying need for autonomy to maximize intrinsic motivation. CSOs were encouraged to reduce their pressure on the veteran to seek care and to engage in more positive activities of interest to both. CSOs were coached to listen for concerns expressed by the veteran, such as complaints about mood, anxiety, or the future (11, 12). CSOs were also encouraged to use an "autonomy-supportive" style of communication, which means offering to help the veteran but stating that it is understood that the offer is subject to the veteran welcoming this assistance. Coaching includes behavioral rehearsal to enhance the learning of these skills.
Overall Study deemed ineligible and administratively withdrawn	1	0
Overall Study Withdrawal by Subject	3	0
Overall Study Lost to Follow-up	7	0

Baseline Characteristics

Measure Analysis Population Description: Age reported of caller participant (CSO) reported for Coaching + VA CRAFT group only. Age not assessed for TAU Coaching group (usual care).

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: At any point during study involvement, up to 1 year after enrollment

Veteran's mental health care engagement was assessed from CSO participants' report.

Outcome measures

Outcome measures
Measure	Coaching + VA CRAFT n=26 Participants Telephone coaching along with web-based CRAFT course Coaching: Telephone coaching was provided in a series of telephone based sessions with CSO participants	Treatment as Usual n=26 Participants Treatment as usual matched comparison Coaching: Telephone coaching was provided in a series of telephone based sessions with CSO participants
Number of Veteran's Engaged in Mental Health Care	7 Participants	5 Participants

Adverse Events

Coaching + VA CRAFT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven L. Sayers

CMC VA Medical Center

Phone: (215) 823-5196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Coaching + VA-CRAFT n=26 Participants The interventionist provided a telephone-guided coaching intervention with the aid of a web-based program, VA-CRAFT, developed by the Co-Investigators for concerned significant others (CSOs). The VA-CRAFT program, based on the original Community Reinforcement and Family Training (CRAFT) program for substance misuse has 8 modules: 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 of the intervention include helping the CSO understand triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and encouraging the Veteran to enter mental health treatment for substance abuse. After viewing each of the VA-CRAFT web-based modules, the interventionist reviewed and personalized the material with the CSO via a telephone conversation. The intervention was flexible within the following framework: 1) 8 to 12, 30-45 min. telephone sessions, every 2-3 weeks, and 2) between 4 and 6 months.	Treatment as Usual (TAU) Coaching n=26 Participants The treatment as usual coaching (TAU) seeks to empower, motivate, educate, and improved the concerned significant others' (CSOs') listening and communication skills with the goal of enhancing the veteran's intrinsic motivation for care. It draws from self-determination theory and emphasizes humans' underlying need for autonomy to maximize intrinsic motivation. CSOs were encouraged to reduce their pressure on the veteran to seek care and to engage in more positive activities of interest to both. CSOs were coached to listen for concerns expressed by the veteran, such as complaints about mood, anxiety, or the future (11, 12). CSOs were also encouraged to use an "autonomy-supportive" style of communication, which means offering to help the veteran but stating that it is understood that the offer is subject to the veteran welcoming this assistance. Coaching includes behavioral rehearsal to enhance the learning of these skills.	Total n=52 Participants Total of all reporting groups
Age, Continuous	37.6 years STANDARD_DEVIATION 7.9 • n=26 Participants • Measure Analysis Population Description: Age reported of caller participant (CSO) reported for Coaching + VA CRAFT group only. Age not assessed for TAU Coaching group (usual care).	—	37.6 years STANDARD_DEVIATION 7.9 • n=26 Participants • Measure Analysis Population Description: Age reported of caller participant (CSO) reported for Coaching + VA CRAFT group only. Age not assessed for TAU Coaching group (usual care).
Sex: Female, Male Female	26 Participants n=26 Participants	26 Participants n=26 Participants	52 Participants n=52 Participants
Sex: Female, Male Male	0 Participants n=26 Participants	0 Participants n=26 Participants	0 Participants n=52 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.	0 Participants Race was not collected as part of TAU data collection for clinical purposes.	0 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.
Race (NIH/OMB) Asian	1 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.	0 Participants Race was not collected as part of TAU data collection for clinical purposes.	1 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.	0 Participants Race was not collected as part of TAU data collection for clinical purposes.	1 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.
Race (NIH/OMB) Black or African American	1 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.	0 Participants Race was not collected as part of TAU data collection for clinical purposes.	1 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.
Race (NIH/OMB) White	23 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.	0 Participants Race was not collected as part of TAU data collection for clinical purposes.	23 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.
Race (NIH/OMB) More than one race	0 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.	0 Participants Race was not collected as part of TAU data collection for clinical purposes.	0 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.	0 Participants Race was not collected as part of TAU data collection for clinical purposes.	0 Participants n=26 Participants • Race was not collected as part of TAU data collection for clinical purposes.
Region of Enrollment United States	26 participants n=26 Participants	26 participants n=26 Participants	52 participants n=52 Participants
Veteran's engagement in MH Care at Baseline	0 Participants n=26 Participants	0 Participants n=26 Participants	0 Participants n=52 Participants
Relationship Spouses/intimate other	21 Participants n=26 Participants	20 Participants n=26 Participants	41 Participants n=52 Participants
Relationship Sibling	1 Participants n=26 Participants	1 Participants n=26 Participants	2 Participants n=52 Participants
Relationship Parent	4 Participants n=26 Participants	5 Participants n=26 Participants	9 Participants n=52 Participants