N/A N=78 Randomized Single-blind Treatment

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

Suicide

Bottom Line

View on ClinicalTrials.gov: NCT03034863 ↗

Enrolled (actual)

Serious AEs

3.9%

Results posted

Dec 2021

Primary outcome: Primary: Veteran Suicidal Ideation — 1.50; 3.50; 1.00; 3.38 units on a scale — p=.03

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Safe Actions for Families to Encourage Recovery (Behavioral); Individual Safety Planning Intervention (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Veteran Suicidal Ideation	1.50; 3.50; 1.00; 3.38	.03 sig
PRIMARY Supporting Partner Caregiver Burden	1.23; 1.00; 0.90; 0.72	.69
PRIMARY Number of Veterans With at Least 1 Suicide Attempt	0; 2; 0; 1	.49
SECONDARY Veteran Suicide Related Coping	3.15; 2.69; 3.12; 2.70	.03 sig
SECONDARY Veteran Thwarted Belongingness	2.85; 3.57; 3.30; 3.45	.87
SECONDARY Partner Support of Suicide-Related Coping	3.65; 3.36; 3.70; 2.89	.03 sig
SECONDARY Veteran Perceived Burdensomeness	2.23; 2.60; 2.10; 2.86	.16
SECONDARY Veteran Hopelessness	7.40; 11.73; 9.09; 12.61	.81
SECONDARY Veteran Depression	21.20; 29.07; 18.33; 31.08	.55
SECONDARY Caregiver's Empowerment to Help Veteran	3.71; 3.91; 3.91; 3.87	.64
SECONDARY Veteran's Report of Family Problem Solving	2.33; 2.23; 2.36; 2.40	.62
SECONDARY Veteran's Report of Family Communication	2.34; 2.33; 2.33; 2.27	.16

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03034863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.