Trial Outcomes & Findings for SAFER: A Brief Intervention Involving Family Members in Suicide Safety Planning (NCT NCT03034863)

Last Updated: 2021-12-10

Results Overview

Suicidality will be measured using the Columbia Suicide Severity Rating Scale. The C-SSRS was used across time points to record level of ideation, lifetime suicide attempts, and recent suicide attempts. The follow-up version of C-SSRS measured suicidal ideation and behavior that had occurred since the last assessment. The scale has inter-rater reliability of .97 and has been used extensively in prospective suicide studies. The scale has a minimum value of 0 and a maximum value of 5. Higher scores mean a worse outcome (more severe ideation).

Recruitment status

COMPLETED

Study phase

Target enrollment

78 participants

Primary outcome timeframe

POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)

Results posted on

2021-12-10

Participant Flow

The study recruited, consented, and randomized 39 Veterans at risk for suicide and 39 corresponding supporting partners over a 30-month period from a large VA medical center in a major metropolitan area in the North East. Recruitment sources included VA suicide prevention coordinators, a Veteran's primary clinician from the VA Medical Center's (VAMC) psychiatric inpatient unit or outpatient care center, or through community outreach (e.g., Vet Centers and higher education institutions).

Participant milestones

Participant milestones
Measure	SAFER Safe Actions for Families to Encourage Recovery (SAFER): A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others. Safe Actions for Families to Encourage Recovery: A novel, 4-session intervention to enhance VA suicide safety planning by involving family members to support its implementation.	I-SPI The comparison condition will be an assessment-only enhanced treatment-as-usual, the currently mandated Individual Safety Planning Intervention (I-SPI). I-SPI incorporates update and use of the safety plan, which will then be uploaded to the Computerized Patient Record System (CPRS) so the Veterans' primary mental health providers can access. Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual called the Individual Safety Planning Intervention (I-SPI).
Overall Study STARTED	38	40
Overall Study Veterans	19	20
Overall Study Supporting Partners	19	20
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	10	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Number analyzed in row differs from overall because this specifically looked at Veteran age whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)

Population: Some participants lost between baseline and post-treatment follow-up and extended 3 month follow up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.

Outcome measures

Outcome measures
Measure	Veterans in SAFER n=15 Participants Veteran participants in the SAFER (intervention) condition	Veterans in I-SPI n=15 Participants Veterans in the I-SPI (control) condition
Veteran Suicidal Ideation Post-Treatment	1.50 units on a scale Standard Deviation 1.93	3.50 units on a scale Standard Deviation 1.43
Veteran Suicidal Ideation Extended Follow-Up	1.00 units on a scale Standard Deviation 1.31	3.38 units on a scale Standard Deviation 2.13

PRIMARY outcome

Population: Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to supporting partners (does not include Veterans) and therefore include about half of the total participants in the study.

Caregiver burden will be evaluated by the Caregiver Burden Inventory (CBI), a 24-item scale assessing caregiver burden in four areas: physical, social, emotional and time dependence burden. Investigators found a large effect size in the pilot multifamily group study on this scale (Cohen's d = 1.03). Items were averaged to create an overall measure of caregiver burden and showed excellent internal consistency in this study (α =.94). CBI scores range from 0 (minimum) to 4 (maximum). Higher scores mean a worse outcome (greater caregiver burden).

Outcome measures

Outcome measures
Measure	Veterans in SAFER n=13 Participants Veteran participants in the SAFER (intervention) condition	Veterans in I-SPI n=13 Participants Veterans in the I-SPI (control) condition
Supporting Partner Caregiver Burden Post-Treatment	1.23 units on a scale Standard Deviation 0.85	1.00 units on a scale Standard Deviation 0.86
Supporting Partner Caregiver Burden Extended Follow-Up	0.90 units on a scale Standard Deviation 0.59	0.72 units on a scale Standard Deviation 0.67

PRIMARY outcome

Population: Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.

These are the number of Veterans who reported at least one or more behaviors coded as "actual suicide attempts" since last visit using the Columbia Suicide Severity Rating Scale (C-SSRS). The follow-up version of C-SSRS measured suicidal ideation and behavior that had occurred since the last assessment. The scale has inter-rater reliability of .97 and has been used extensively in prospective suicide studies. A behavior was considered an "actual suicide attempt" if it was a potentially self-injurious act with any intent to die associated with it.

Outcome measures

Outcome measures
Measure	Veterans in SAFER n=15 Participants Veteran participants in the SAFER (intervention) condition	Veterans in I-SPI n=15 Participants Veterans in the I-SPI (control) condition
Number of Veterans With at Least 1 Suicide Attempt Post-Treatment	0 Participants	2 Participants
Number of Veterans With at Least 1 Suicide Attempt Extended Follow-Up	0 Participants	1 Participants

SECONDARY outcome

Suicide-related coping will be evaluated by the Stanley Suicide-related Coping Scale (SRCS), a 21-item self-report measure developed by Stanley, Green, Holloway, Brenner \& Brown to evaluate appraisal of one's ability to cope with suicidal ideation and urges, as well as ability to use the Safety Plan. Examples of items are: "I am at the mercy of my suicidal thoughts", "I have several things I can do to get through a suicidal crisis". Scores were averaged so that higher scores represent greater confidence and breadth of approaches to coping with suicidal thoughts and feelings (better outcome). SRCS scores have a minimum of 0 and a maximum of 4.

Outcome measures

Outcome measures
Measure	Veterans in SAFER n=15 Participants Veteran participants in the SAFER (intervention) condition	Veterans in I-SPI n=15 Participants Veterans in the I-SPI (control) condition
Veteran Suicide Related Coping Extended Follow-Up	3.12 units on a scale Standard Deviation 0.59	2.70 units on a scale Standard Deviation 0.86
Veteran Suicide Related Coping Post-Treatment	3.15 units on a scale Standard Deviation 0.71	2.69 units on a scale Standard Deviation 1.02

SECONDARY outcome

Thwarted belongingness will be evaluated by Interpersonal Needs Questionnaire (INQ-15). The INQ is has demonstrated acceptable internal consistency for thwarted belongingness in this sample (TB) (α =.79). Scores on each subscale were averaged so that higher scores represent a greater degree of their respective constructs. Thwarted belongingness scores range from 1 (minimum) to 6 (maximum). Higher scores mean a worse outcome (decreased feelings of belongingness).

Outcome measures

Outcome measures
Measure	Veterans in SAFER n=15 Participants Veteran participants in the SAFER (intervention) condition	Veterans in I-SPI n=15 Participants Veterans in the I-SPI (control) condition
Veteran Thwarted Belongingness Post-Treatment	2.85 units on a scale Standard Deviation 1.27	3.57 units on a scale Standard Deviation 1.22
Veteran Thwarted Belongingness Extended Follow-Up	3.30 units on a scale Standard Deviation 1.46	3.45 units on a scale Standard Deviation 0.95

SECONDARY outcome

We have developed a family counterpart to the Stanley Suicide-related Coping Scale for Veterans that taps family members' appraisal of their ability to participate effectively in Veteran safety planning. Items include, "I recognize the triggers and warning signs for suicidal ideation/urges for my Veteran" and "I know the numbers for the mobile crisis team to contact and nearest hospital or urgent care facility to accompany my Veteran to in a crisis." This measure will be validated against the more general Family Empowerment Scale. Items were rated on a 0 (Strongly Disagree) to 4 (Strongly Agree) scale and were averaged with higher scores indicating greater self-efficacy when supporting the Veteran through suicidal crises (better outcome). Partner SRCS scores range from 0 (minimum) to 4 (maximum).

Outcome measures

Outcome measures
Measure	Veterans in SAFER n=13 Participants Veteran participants in the SAFER (intervention) condition	Veterans in I-SPI n=13 Participants Veterans in the I-SPI (control) condition
Partner Support of Suicide-Related Coping Post-Treatment	3.65 units on a scale Standard Deviation 0.46	3.36 units on a scale Standard Deviation 0.71
Partner Support of Suicide-Related Coping Extended Follow-Up	3.70 units on a scale Standard Deviation 0.57	2.89 units on a scale Standard Deviation 1.4

SECONDARY outcome

Perceived burdensomeness will be evaluated by Interpersonal Needs Questionnaire (INQ-15). The INQ is has demonstrated excellent internal consistency for Perceived Burdensomeness (PB) (α= .95). Scores on each subscale were averaged so that higher scores represent a greater degree of their respective constructs. Perceived burdensomeness scores range from 1 (minimum) to 6 (maximum). Higher scores mean a worse outcome (greater perceived burdensomeness).

Outcome measures

Outcome measures
Measure	Veterans in SAFER n=15 Participants Veteran participants in the SAFER (intervention) condition	Veterans in I-SPI n=15 Participants Veterans in the I-SPI (control) condition
Veteran Perceived Burdensomeness Post-Treatment	2.23 units on a scale Standard Deviation 1.39	2.60 units on a scale Standard Deviation 1.68
Veteran Perceived Burdensomeness Extended Follow-Up	2.10 units on a scale Standard Deviation 1.63	2.86 units on a scale Standard Deviation 1.42

SECONDARY outcome

Veteran hopelessness will be evaluated by the Beck Hopelessness Scale (BHS), a 20-item self-report measure with adequate reliability and validity which has been predictive of suicide in psychiatric inpatients. The BHS measures three aspects of hopelessness: feelings about the future, loss of motivation, and expectations. Items are true-false and are summed to get a total BHS score, ranging from 0 to 20. Higher scores reflect a worse outcome (greater hopelessness).

Outcome measures

Outcome measures
Measure	Veterans in SAFER n=15 Participants Veteran participants in the SAFER (intervention) condition	Veterans in I-SPI n=15 Participants Veterans in the I-SPI (control) condition
Veteran Hopelessness Post-Treatment	7.40 units on a scale Standard Deviation 6.49	11.73 units on a scale Standard Deviation 7.06
Veteran Hopelessness Extended Follow-Up	9.09 units on a scale Standard Deviation 7.84	12.61 units on a scale Standard Deviation 6.70

SECONDARY outcome

Veteran depression will be evaluated by the widely-used Beck Depression Inventory-II (BDI-II) (Cronbach's = .92). The BDI-II contains 21 items assessing depressive symptoms, each with minimum scores of 0 and maximum scores of 3. Item scores were summed, leading to a total score range of 0-63. Higher scores mean a worse outcome (more severe depressive symptoms).

Outcome measures

Outcome measures
Measure	Veterans in SAFER n=15 Participants Veteran participants in the SAFER (intervention) condition	Veterans in I-SPI n=15 Participants Veterans in the I-SPI (control) condition
Veteran Depression Post-Treatment	21.20 units on a scale Standard Deviation 16.92	29.07 units on a scale Standard Deviation 18.67
Veteran Depression Extended Follow-Up	18.33 units on a scale Standard Deviation 16.20	31.08 units on a scale Standard Deviation 17.67

SECONDARY outcome

Caregiving self-efficacy/empowerment will be evaluated using the 12-item family subscale from the Family Empowerment Scale. This scale assesses the family's knowledge of mental health services and perceived ability to manage crises, and has demonstrated sensitivity to change in family intervention studies. Each item has a minimum score of 1 and a maximum score of 5, and were averaged to create a total score range of 1-5. Higher scores mean a better outcome (greater empowerment).

Outcome measures

Outcome measures
Measure	Veterans in SAFER n=13 Participants Veteran participants in the SAFER (intervention) condition	Veterans in I-SPI n=13 Participants Veterans in the I-SPI (control) condition
Caregiver's Empowerment to Help Veteran Post-Treatment	3.71 units on a scale Standard Deviation 0.78	3.91 units on a scale Standard Deviation 0.94
Caregiver's Empowerment to Help Veteran Extended Follow-Up	3.91 units on a scale Standard Deviation 0.67	3.87 units on a scale Standard Deviation 0.86

SECONDARY outcome

Veterans' reports of family problem solving will be evaluated by the 5-item Problem Solving subscale of the Family Assessment Device (FAD). Subscales have acceptable internal consistency (α = .72 to .83). Each item has a minimum score of 1 and a maximum score of 4, and were averaged to create a total score range of 1-4. Higher scores reflect worse outcomes (lower problem solving ability).

Outcome measures

Outcome measures
Measure	Veterans in SAFER n=15 Participants Veteran participants in the SAFER (intervention) condition	Veterans in I-SPI n=15 Participants Veterans in the I-SPI (control) condition
Veteran's Report of Family Problem Solving Post-Treatment	2.33 units on a scale Standard Deviation 0.86	2.23 units on a scale Standard Deviation 0.81
Veteran's Report of Family Problem Solving Extended Follow-Up	2.36 units on a scale Standard Deviation 0.64	2.40 units on a scale Standard Deviation 1.01

SECONDARY outcome

Veterans' reports of family communication will be evaluated by the 6-item Communication subscale of the Family Assessment Device (FAD). Subscales have acceptable internal consistency (α = .72 to .83). Each item has a minimum score of 1 and a maximum score of 4, and were averaged to create a total score range of 1-4. Higher scores reflect worse outcomes (worse communication).

Outcome measures

Outcome measures
Measure	Veterans in SAFER n=15 Participants Veteran participants in the SAFER (intervention) condition	Veterans in I-SPI n=15 Participants Veterans in the I-SPI (control) condition
Veteran's Report of Family Communication Post-Treatment	2.34 units on a scale Standard Deviation 0.39	2.33 units on a scale Standard Deviation 0.54
Veteran's Report of Family Communication Extended Follow-Up	2.33 units on a scale Standard Deviation 0.28	2.27 units on a scale Standard Deviation 0.44

Adverse Events

SAFER: Veterans

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

I-SPI: Veterans

Serious events: 2 serious events

Other events: 1 other events

Deaths: 1 deaths

SAFER: Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

I-SPI: Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	SAFER: Veterans n=19 participants at risk SAFER: A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others. Safe Actions for Families to Encourage Recovery: A novel, 4-session intervention to enhance VA suicide safety planning by involving family members to support its implementation.	I-SPI: Veterans n=20 participants at risk The comparison condition will be an assessment-only enhanced treatment-as-usual (E-TAU), incorporating update and use of the safety plan, which will then be uploaded to CPRS so the Veterans' primary mental health providers can access. Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual (TAU).	SAFER: Caregivers n=19 participants at risk SAFER: A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.	I-SPI: Caregivers n=20 participants at risk The comparison condition will be an assessment-only enhanced treatment-as-usual (E-TAU), incorporating update and use of the safety plan, which will then be uploaded to CPRS so the Veterans' primary mental health providers can access. Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual (TAU).
Surgical and medical procedures Knee Operation	0.00% 0/19 • 1 year, 8 months	5.0% 1/20 • Number of events 1 • 1 year, 8 months	0.00% 0/19 • 1 year, 8 months	0.00% 0/20 • 1 year, 8 months
Psychiatric disorders Psychiatric Hospitalization	5.3% 1/19 • Number of events 1 • 1 year, 8 months	5.0% 1/20 • Number of events 1 • 1 year, 8 months	0.00% 0/19 • 1 year, 8 months	0.00% 0/20 • 1 year, 8 months

Other adverse events

Other adverse events
Measure	SAFER: Veterans n=19 participants at risk SAFER: A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others. Safe Actions for Families to Encourage Recovery: A novel, 4-session intervention to enhance VA suicide safety planning by involving family members to support its implementation.	I-SPI: Veterans n=20 participants at risk The comparison condition will be an assessment-only enhanced treatment-as-usual (E-TAU), incorporating update and use of the safety plan, which will then be uploaded to CPRS so the Veterans' primary mental health providers can access. Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual (TAU).	SAFER: Caregivers n=19 participants at risk SAFER: A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.	I-SPI: Caregivers n=20 participants at risk The comparison condition will be an assessment-only enhanced treatment-as-usual (E-TAU), incorporating update and use of the safety plan, which will then be uploaded to CPRS so the Veterans' primary mental health providers can access. Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual (TAU).
Renal and urinary disorders ER for Urination Issue	5.3% 1/19 • Number of events 1 • 1 year, 8 months	0.00% 0/20 • 1 year, 8 months	0.00% 0/19 • 1 year, 8 months	0.00% 0/20 • 1 year, 8 months
Nervous system disorders ER for Dizziness	0.00% 0/19 • 1 year, 8 months	5.0% 1/20 • Number of events 1 • 1 year, 8 months	0.00% 0/19 • 1 year, 8 months	0.00% 0/20 • 1 year, 8 months

Additional Information

Marianne Goodman, MD

James J Peters VAMC

Phone: 718-584-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place