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

NCT ID: NCT03034863

Last Updated: 2021-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-03
• Study Completion Date: 2020-02-28

Brief 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.

Detailed 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.

Conditions

Suicide

Keywords

Family Caregivers; Spouse Caregivers; Veterans; Suicide; Clinical Trial; Military Families; Military Psychology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SAFER

SAFER (Safe Actions for Families to Encourage Recovery): A novel, 5-session intervention to enhance currently mandated VA suicide safety planning by involving supporting partners 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 supporting partners with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or partner 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 partner support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.

Group Type: EXPERIMENTAL

Safe Actions for Families to Encourage Recovery

Intervention Type: BEHAVIORAL

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.

I-SPI

The comparison condition will be an assessment-only enhanced treatment-as-usual called the Individual Safety Planning Intervention (I-SPI), incorporating weekly scripted check-in phone calls to review mood symptoms and use of the safety plan, which will then be given as feedback to the Veteran's primary mental health provider.

Group Type: ACTIVE_COMPARATOR

Individual Safety Planning Intervention

Intervention Type: BEHAVIORAL

The comparison condition will be an assessment-only enhanced treatment-as-usual intervention called the Individual Safety Planning Intervention (I-SPI).

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

SAFER; I-SPI

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianne S. Goodman, MD

Role: PRINCIPAL_INVESTIGATOR

James J. Peters Veterans Affairs Medical Center

Locations

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RX002432-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

D2432-R

Identifier Type: -

Identifier Source: org_study_id