SAFER: A Brief Intervention Involving Family Members in Suicide Safety Planning (NCT03034863) | Clinical Trial Compass
CompletedNot Applicable
SAFER: A Brief Intervention Involving Family Members in Suicide Safety Planning
United States78 participantsStarted 2017-07-03
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
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)
3
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)