Clinical trial NCT03034863: SAFER: A Brief Intervention Involving Family Members in Suicide Safety Planning
Official title: SAFER: A Brief Intervention Involving Family Members in Suicide Safety Planning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Family Caregivers
Spouse Caregivers
Veterans
Suicide
Clinical Trial
Military Families
Military Psychology
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-01-27
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Veteran Suicidal Ideation
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)
measure: Supporting Partner Caregiver Burden
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)
measure: Number of Veterans With at Least 1 Suicide Attempt
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)
Secondary outcomes:
measure: Veteran Suicide Related Coping
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)
measure: Veteran Thwarted Belongingness
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)
measure: Partner Support of Suicide-Related Coping
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)
measure: Veteran Perceived Burdensomeness
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)
measure: Veteran Hopelessness
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)
measure: Veteran Depression
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)
measure: Caregiver's Empowerment to Help Veteran
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)
measure: Veteran's Report of Family Problem Solving
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)
measure: Veteran's Report of Family Communication
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)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
Study officials:
affiliation: James J. Peters Veterans Affairs Medical Center
name: Marianne S. Goodman, MD
role: PRINCIPAL_INVESTIGATOR
References: