Trial Outcomes & Findings for Helping Families Help Veterans With PTSD and Alcohol Abuse: An RCT of VA-CRAFT (NCT NCT01678196)

Last Updated: 2016-10-25

Results Overview

Administrative data on mental health service utilization for Veterans will be compared for those whose family members receive the intervention (VA-CRAFT) and those who do not.

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

3 months after initiation of the intervention

Results posted on

2016-10-25

Participant Flow

Participants were partners of Veterans who had screened positive for PTSD or alcohol use disorders in prior surveys with the study team. Of 287 identified eligible partners, 190 were successfully reached and 66 consented to be in the study.

Participant milestones

Participant milestones
Measure	VA-CRAFT Family participants complete an on-line training course (VA-CRAFT) over a 3 month period VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.	Control Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Overall Study STARTED	34	32
Overall Study COMPLETED	34	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Helping Families Help Veterans With PTSD and Alcohol Abuse: An RCT of VA-CRAFT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VA-CRAFT n=34 Participants Family participants complete an on-line training course (VA-CRAFT) over a 3 month period VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.	Control n=32 Participants Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	32 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months after initiation of the intervention

Administrative data on mental health service utilization for Veterans will be compared for those whose family members receive the intervention (VA-CRAFT) and those who do not.

Outcome measures

Outcome measures
Measure	VA-CRAFT n=34 Participants Family participants complete an on-line training course (VA-CRAFT) over a 3 month period VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.	Control n=32 Participants Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Veteran Engagement in VA Mental Health Services	4 participants	4 participants

SECONDARY outcome

Timeframe: 3 months after initiation of the intervention

Population: Group sample sizes are smaller than total sample sizes due to missing data.

Brief Symptom Inventory - 18 (Derogatis, 1993) is an 18 item measure of general mental health symptoms and distress. The total score is used, which is the mean of 18 items rated from 0 (not at all) to 4 (extremely) distressing. Total scores range from 0 (low distress) to 4 (high distress).

Outcome measures

Outcome measures
Measure	VA-CRAFT n=32 Participants Family participants complete an on-line training course (VA-CRAFT) over a 3 month period VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.	Control n=29 Participants Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18	0.46 units on a scale Standard Deviation 0.52	0.58 units on a scale Standard Deviation 0.59

SECONDARY outcome

Timeframe: 3 months after the initiation of the intervention

Population: Sample sizes are smaller than the overall sample due to missing questionnaire data.

Relationship Happiness Scale. The RHS is a 9 item scale of general happiness in close relationships. The total score is reported here, reflecting the mean of the 9 items rated on a scale of 1 (completely unhappy) to 10 (completely happy). Higher total scores reflect greater relationship happiness.

Outcome measures

Outcome measures
Measure	VA-CRAFT n=32 Participants Family participants complete an on-line training course (VA-CRAFT) over a 3 month period VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.	Control n=28 Participants Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Family Functioning	5.92 units on a scale Standard Deviation 1.78	5.75 units on a scale Standard Deviation 2.36

SECONDARY outcome

Timeframe: 3 months post-randomization

Population: Sample sizes are smaller than total sample size due to missing questionnaire data.

Caregiver Burden Scale (CBS). The CBS is a 16 items scale assessing caregiver burden. It has 16 items rated from 1 (not at all) to 5 (extremely) distressed or burdened. Scores reported are the total scale scores, calculated as the mean of the 16 items, with a range from 1 (low burden) to 5 (high burden).

Outcome measures

Outcome measures
Measure	VA-CRAFT n=32 Participants Family participants complete an on-line training course (VA-CRAFT) over a 3 month period VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.	Control n=29 Participants Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
Caregiver Burden	1.56 units on a scale Standard Deviation 0.49	1.84 units on a scale Standard Deviation 0.88

Adverse Events

VA-CRAFT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Christopher Erbes, PhD

Minneapolis VA Healthcare Service Center

Phone: 612-725-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place