Trial Outcomes & Findings for Caring Cards to and From Veterans: A Peer Approach to Suicide Prevention (NCT NCT04486677)
NCT ID: NCT04486677
Last Updated: 2024-05-02
Results Overview
Feasibility will be measured by the proportion of Veterans 1) referred for screening, 2) determined eligible, 3) enrolled/completed baseline, and 4) complete follow-up assessments.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Through study completion, approximately 1 year, 8 months
Results posted on
2024-05-02
Participant Flow
Participant milestones
| Measure |
Caring Cards Group
Group of Veteran card-makers.
Caring Cards Group: Group of Veteran card-makers.
|
Caring Cards Recipients
Group of Veteran card-recipients.
Caring Cards Recipients: Group of Veteran card-recipients.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
50
|
|
Overall Study
COMPLETED
|
21
|
34
|
|
Overall Study
NOT COMPLETED
|
9
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caring Cards to and From Veterans: A Peer Approach to Suicide Prevention
Baseline characteristics by cohort
| Measure |
Caring Cards Group
n=30 Participants
Group of Veteran card-makers.
Caring Cards Group: Group of Veteran card-makers.
|
Caring Cards Recipients
n=50 Participants
Group of Veteran card-recipients.
Caring Cards Recipients: Group of Veteran card-recipients.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Era of Military Service
Persian Gulf War
|
26 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Era of Military Service
Post-Vietnam
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Era of Military Service
Vietnam
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through study completion, approximately 1 year, 8 monthsFeasibility will be measured by the proportion of Veterans 1) referred for screening, 2) determined eligible, 3) enrolled/completed baseline, and 4) complete follow-up assessments.
Outcome measures
| Measure |
Caring Cards Group
n=380 Participants
Group of Veteran card-makers.
Caring Cards Group: Group of Veteran card-makers.
|
Caring Cards Recipients
n=370 Participants
Group of Veteran card-recipients.
Caring Cards Recipients: Group of Veteran card-recipients.
|
|---|---|---|
|
Feasibility
referred for screening
|
242 Participants
|
234 Participants
|
|
Feasibility
determined eligible
|
212 Participants
|
233 Participants
|
|
Feasibility
enrolled/completed baseline
|
30 Participants
|
50 Participants
|
|
Feasibility
complete follow-up assessments
|
21 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: Through study completion, approximately 1 year, 8 monthsIntervention Satisfaction Questionnaire will be collected from participants following intervention delivery to measure acceptability of the Caring Cards intervention.
Outcome measures
| Measure |
Caring Cards Group
n=21 Participants
Group of Veteran card-makers.
Caring Cards Group: Group of Veteran card-makers.
|
Caring Cards Recipients
n=34 Participants
Group of Veteran card-recipients.
Caring Cards Recipients: Group of Veteran card-recipients.
|
|---|---|---|
|
Intervention Satisfaction Questionnaire (Acceptability)
Perception of benefit
|
13 Participants
|
21 Participants
|
|
Intervention Satisfaction Questionnaire (Acceptability)
Recommend to other Veterans
|
11 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Change from baseline, an average of 9 monthsAt baseline and follow-up, Veterans will complete the INQ-12 to assess for thwarted belongingness and perceived burdensomeness. Each item on the INQ is rated on a 1-7 Likert scale so the full range of the measure is 12-105, with scores meaning higher thwarted belongingness and perceived burdensomeness (i.e., a worse outcome).
Outcome measures
| Measure |
Caring Cards Group
n=21 Participants
Group of Veteran card-makers.
Caring Cards Group: Group of Veteran card-makers.
|
Caring Cards Recipients
n=34 Participants
Group of Veteran card-recipients.
Caring Cards Recipients: Group of Veteran card-recipients.
|
|---|---|---|
|
Interpersonal Needs Questionnaire (INQ-15)
Baseline
|
39.19 score on a scale
Standard Deviation 24.07
|
54.35 score on a scale
Standard Deviation 21.15
|
|
Interpersonal Needs Questionnaire (INQ-15)
9 month follow up
|
36.67 score on a scale
Standard Deviation 21.16
|
49.18 score on a scale
Standard Deviation 23.13
|
SECONDARY outcome
Timeframe: Change from baseline, an average of 9 monthsAt baseline and follow-up, Veterans' suicide risk was assessed using the Beck Scale for Suicide Ideation (BSSI). It is a 19 item measure on a 0-2 point scale for a range of 0-38, with higher scores indicating higher suicidal ideation or worse outcomes. There are two additional questions about suicide attempts that are not included in the total score.
Outcome measures
| Measure |
Caring Cards Group
n=21 Participants
Group of Veteran card-makers.
Caring Cards Group: Group of Veteran card-makers.
|
Caring Cards Recipients
n=34 Participants
Group of Veteran card-recipients.
Caring Cards Recipients: Group of Veteran card-recipients.
|
|---|---|---|
|
Suicide Risk
Baseline
|
5.95 score on a scale
Standard Deviation 5.83
|
11.50 score on a scale
Standard Deviation 6.33
|
|
Suicide Risk
9 month follow up
|
6.10 score on a scale
Standard Deviation 4.55
|
10.21 score on a scale
Standard Deviation 7.31
|
SECONDARY outcome
Timeframe: Change from baseline, an average of 9 monthsAt baseline and follow-up, Veterans will complete the NIH Toolbox Adult Social Relationships Scales to assess social connectedness. There were three subscales included: Perceived Rejection, Loneliness, and Emotional Support. Each includes items rated on a 1-5 scale. Perceived Rejection is 8 items for a range of 8-40, Loneliness is 5 items for a range of 5-25, and Emotional Support is 8 items for a range of 8-40. Higher scores are associated with worse outcomes for Perceived Rejection and Loneliness, while higher scores are associated with better outcomes for Emotional Support.
Outcome measures
| Measure |
Caring Cards Group
n=21 Participants
Group of Veteran card-makers.
Caring Cards Group: Group of Veteran card-makers.
|
Caring Cards Recipients
n=34 Participants
Group of Veteran card-recipients.
Caring Cards Recipients: Group of Veteran card-recipients.
|
|---|---|---|
|
NIH Toolbox Adult Social Relationships Scales
Baseline (Perceived Rejection)
|
17.52 score on a scale
Standard Deviation 9.10
|
21.79 score on a scale
Standard Deviation 8.29
|
|
NIH Toolbox Adult Social Relationships Scales
Follow up (Perceived Rejection)
|
18.91 score on a scale
Standard Deviation 8.58
|
18.41 score on a scale
Standard Deviation 8.37
|
|
NIH Toolbox Adult Social Relationships Scales
Baseline (Loneliness)
|
14.19 score on a scale
Standard Deviation 6.42
|
18.59 score on a scale
Standard Deviation 4.83
|
|
NIH Toolbox Adult Social Relationships Scales
Follow up (Loneliness)
|
13.38 score on a scale
Standard Deviation 5.81
|
17.29 score on a scale
Standard Deviation 6.59
|
|
NIH Toolbox Adult Social Relationships Scales
Baseline (Emotional support)
|
31.19 score on a scale
Standard Deviation 8.69
|
26.18 score on a scale
Standard Deviation 8.69
|
|
NIH Toolbox Adult Social Relationships Scales
Follow up (Emotional support)
|
31.52 score on a scale
Standard Deviation 9.67
|
29.47 score on a scale
Standard Deviation 10.50
|
Adverse Events
Caring Cards Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caring Cards Recipients
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caring Cards Group
n=30 participants at risk
Group of Veteran card-makers.
Caring Cards Group: Group of Veteran card-makers.
|
Caring Cards Recipients
n=50 participants at risk
Group of Veteran card-recipients.
Caring Cards Recipients: Group of Veteran card-recipients.
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/30 • Adverse event data was collected from the time of participant entry into the study until final assessment, which averaged 9 months.
Systematic method: Veterans with active high-risk suicide flags are closely monitored and assessed by VA Suicide Prevention Coordinator (SPCs). At baseline and follow-up, participants are administered two suicide screening measures. Veterans who screen positive immediately meet with a licensed provider. Any new suicidal behavior will be documented in a VA-required report. Trained staff will assess and refer Veterans who require immediate medical attention or psychiatric treatment.
|
4.0%
2/50 • Number of events 2 • Adverse event data was collected from the time of participant entry into the study until final assessment, which averaged 9 months.
Systematic method: Veterans with active high-risk suicide flags are closely monitored and assessed by VA Suicide Prevention Coordinator (SPCs). At baseline and follow-up, participants are administered two suicide screening measures. Veterans who screen positive immediately meet with a licensed provider. Any new suicidal behavior will be documented in a VA-required report. Trained staff will assess and refer Veterans who require immediate medical attention or psychiatric treatment.
|
Other adverse events
| Measure |
Caring Cards Group
n=30 participants at risk
Group of Veteran card-makers.
Caring Cards Group: Group of Veteran card-makers.
|
Caring Cards Recipients
n=50 participants at risk
Group of Veteran card-recipients.
Caring Cards Recipients: Group of Veteran card-recipients.
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/30 • Adverse event data was collected from the time of participant entry into the study until final assessment, which averaged 9 months.
Systematic method: Veterans with active high-risk suicide flags are closely monitored and assessed by VA Suicide Prevention Coordinator (SPCs). At baseline and follow-up, participants are administered two suicide screening measures. Veterans who screen positive immediately meet with a licensed provider. Any new suicidal behavior will be documented in a VA-required report. Trained staff will assess and refer Veterans who require immediate medical attention or psychiatric treatment.
|
12.0%
6/50 • Number of events 6 • Adverse event data was collected from the time of participant entry into the study until final assessment, which averaged 9 months.
Systematic method: Veterans with active high-risk suicide flags are closely monitored and assessed by VA Suicide Prevention Coordinator (SPCs). At baseline and follow-up, participants are administered two suicide screening measures. Veterans who screen positive immediately meet with a licensed provider. Any new suicidal behavior will be documented in a VA-required report. Trained staff will assess and refer Veterans who require immediate medical attention or psychiatric treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place