SAFER: A Brief Intervention Involving Family Members in Suicide Safety Planning

Suicide Clinical Trial

— SAFER  

Official title:

SAFER: A Brief Intervention Involving Family Members in Suicide Safety Planning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034863
• Other study ID #: D2432-R
• Secondary ID: RX002432-01
• Status: Completed
• Phase: N/A
• Start date: July 3, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: November 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The management of suicide risk is a pressing national public health issue especially among Veterans, and there exist no guidelines of how best to involve family members in this effort. This proposal will integrate family and couples communication skills training with suicide safety planning. The goal is for the sharing of Veteran suicide safety plans with family members and the construction of a parallel family member safety plan, in efforts to mobilize and support family involvement.

Description:

Psychological models of suicidality emphasize the role of social factors in the development and intensification of suicidal thoughts and behavior, including feeling like a burden on family and friends, feelings of isolation and not belonging, and perceptions of diminished support from one's family and social network. Despite the critical role of family factors in protecting against suicidality, families lack education on how their behavior can help avert or unwittingly aggravate suicidal thoughts/ behavior. Families worry about their relative but feel uncertain of how to help and need professional guidance. Family worries about suicidality are associated with compromised family physical and mental health and consequently, diminished ability to offer needed support. Because suicide safety plans rely on mobilizing support in times of crisis, families need to be equipped to provide needed support.

Family recommendations from the VA Behavioral Health Autopsy Program (BHAP) Annual Report 6/30/15 based on interviews with 114 family members highlighted the importance of:

1. educating families about suicide warning signs:

2. improving communication between the veteran and family member

3. involving the family in the veterans' treatment to enhance support and trust

4. providing families with coaching on how to assist their loved one to seek help.

Management of suicidal behavior is covered in comprehensive family psychoeducation programs, but there is an urgent need for a brief family-based intervention specifically focused on suicide prevention that can be used in conjunction with the currently mandated SSP and as a part of routine care.

Despite the enrichment of VA suicide prevention services and implementation of the national suicide hotline, Veteran suicide completions have risen to 22 per day and suicide attempts numbered over 15,000 in 2012. These data underscore the urgency of developing additional interventions targeting suicidal Veterans. One potential avenue to further suicide treatment and rehabilitation efforts is to develop strategies that maximize family support, however almost no family interventions exist for suicidal Veterans. The construction of a Suicide Safety Plan (SSP); a "best practice," is mandated throughout the VA system, and a vital component of the VA's coordinated effort at suicide prevention and recovery. The pilot data on patterns of SSP use in suicidal Veterans highlighted the importance of sharing the plan with family or close friends. However, respondents also noted significant obstacles in their ability to reach out to others when in distress. To the knowledge of Investigators, there are currently no recommended guidelines or mechanisms for involving family in safety planning, despite its inclusion as a step of the plan. "Safe Actions for Families to Encourage Recovery" (SAFER) a novel suicide safety planning family intervention has been designed to fill this critical gap and provide a mechanism to communicate about safety planning. SAFER, a 4-session, family intervention, combines education about suicide and suicide safety planning with communication skills training from evidence-based practices. The aim is to facilitate communication about suicide safety planning and to develop both a Veteran and family member safety plan.

Data from this project will test the intervention's feasibility, acceptability and preliminary efficacy in a Stage II small-scale randomized clinical trial in 39 moderate suicide risk Veterans and their supporting partners. The comparison condition will be safety planning without supporting partner involvement plus weekly check-in phone calls. Primary Veteran outcomes include reducing suicidal ideation/behavior. Secondary Veteran outcomes include reducing suicidal cognitions (hopelessness, perceived burdensomeness, thwarted belongingness) and depression and improving subjective social support. Supporting Partner primary outcomes include reducing caregiver burden and secondary outcomes of improving suicide-related coping and family empowerment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 28, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

Inclusion criteria-Veterans:

• Eligible Veterans must be identified as at moderate risk for suicide, defined as:

• evidence of current (within the past week) suicidal ideation

• plan or intent on the Columbia Suicide Severity Rating Scale (C-SSRS), but scoring less than or equal to 4 on the C-SSRS Behavior Scale, and without history of a lethal suicide attempt in the last 3 months.

Inclusion criteria also include the availability of a consenting, qualifying family member or spouse/cohabiting partner.

Inclusion criteria-family member/significant others:

• Family members/friends must meet at least three (two for nonrelatives) of five criteria:

• is a spouse, co-habiting significant other or parent

• has more frequent contact than any other caregiver

• helps to support the patient financially

• is contacted by treatment staff for emergencies

• has been involved in the patient's treatment

Exclusion Criteria:

Exclusion criteria for Veterans and family/partners are:

• untreated or un-medicated psychosis

• current alcohol or drug abuse or dependence defined by a Patient Health Questionnaire (PHQ) for Alcohol & Drug Use

• for couples, "severe" intimate-partner violence as defined by the revised 20-item Conflict Tactics Scale Short Form (CTS2S)

• medical condition or life event, e.g.,

• participation in another family-based psychosocial intervention trial six months prior to study

• limited English proficiency. Participants will be screened for inclusion/exclusion as described above immediately after giving consent.

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• Safe Actions for Families to Encourage Recovery
A novel, 5-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 with assurance that such requests will be listened to with validation and support, creating an ally for the suicidal Veteran in his struggle. As discussed above, research has demonstrated compellingly that suicidal desire is motivated by two interpersonal factors; perceived burdensomeness and thwarted belongingness. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.
• Individual Safety Planning Intervention
The comparison condition will be an assessment-only enhanced treatment-as-usual intervention called the Individual Safety Planning Intervention (I-SPI).

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Veteran Suicidal Ideation	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).	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)
Primary	Supporting Partner Caregiver Burden	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 (a =.94). CBI scores range from 0 (minimum) to 4 (maximum). Higher scores mean a worse outcome (greater caregiver burden).	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)
Primary	Number of Veterans With at Least 1 Suicide Attempt	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.	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)
Secondary	Veteran Suicide Related Coping	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.	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)
Secondary	Veteran Thwarted Belongingness	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) (a =.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).	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)
Secondary	Partner Support of Suicide-Related Coping	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).	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)
Secondary	Veteran Perceived Burdensomeness	Perceived burdensomeness will be evaluated by Interpersonal Needs Questionnaire (INQ-15). The INQ is has demonstrated excellent internal consistency for Perceived Burdensomeness (PB) (a= .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).	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)
Secondary	Veteran Hopelessness	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).	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)
Secondary	Veteran Depression	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).	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)
Secondary	Caregiver's Empowerment to Help Veteran	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).	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)
Secondary	Veteran's Report of Family Problem Solving	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 (a = .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).	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)
Secondary	Veteran's Report of Family Communication	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 (a = .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).	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)