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

NCT03034863 | Completed Results

• 2 other identifiers: D2432-RRX002432-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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)

• 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 (α =.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)

• 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 Outcomes (9)

• Veteran Suicide Related Coping

  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)

• Veteran Thwarted 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)

• Partner Support of Suicide-Related Coping

  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)

• Veteran 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)

• Veteran 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)

Study Arms (2)

SAFER

EXPERIMENTAL

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.

Behavioral: Safe Actions for Families to Encourage Recovery

I-SPI

ACTIVE COMPARATOR

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.

Behavioral: Individual Safety Planning Intervention

Interventions

Safe Actions for Families to Encourage Recovery 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.

Also known as: SAFER

SAFER

Individual Safety Planning Intervention BEHAVIORAL

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

Also known as: I-SPI

I-SPI

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

The proposed evaluation of SAFER has limitations. First, our strategy only targeted moderate risk suicidal Veterans. Second, there was a relatively small sample size of 39 suicidal Veterans and 39 supporting partners. Third, conducting the study in a high density, urban setting may result in different findings than if conducted in a rural setting. Fourth, the study arms were not matched for treatment dosage (SAFER: 4 sessions versus I-SPI: single session).

Results Point of Contact

• Title: Marianne Goodman, MD
• Organization: James J Peters VAMC

Marianne.Goodman@va.gov

718-584-9000

Study Officials

• Marianne S. Goodman, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individual who evaluates the outcomes of interest will not know the assigned condition of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 27, 2017
• Study Start: July 3, 2017
• Primary Completion: December 31, 2019
• Study Completion: February 28, 2020
• Last Updated: December 10, 2021
• Results First Posted: December 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)