Self-Guided Electronic Safety Plan for Suicide Prevention
(Project SAFER Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on a digital intervention, so it's likely you can continue your current medications, but please confirm with the trial organizers.
What data supports the effectiveness of the Self-Guided Electronic Safety Plan Intervention treatment for suicide prevention?
Research shows that safety planning is an effective way to reduce suicidal thoughts and behaviors. Studies have found that using safety plans, including electronic versions, can help decrease feelings of depression and hopelessness, and improve treatment engagement. This suggests that a self-guided electronic safety plan could be a useful tool in preventing suicide.12345
Is the Self-Guided Electronic Safety Plan for Suicide Prevention safe for humans?
The Self-Guided Electronic Safety Plan, also known as the Safety Planning Intervention (SPI), has been shown to be a feasible and acceptable approach for suicide prevention. Studies suggest it is safe and can be delivered in various formats, including digital and self-administered versions, without reported safety concerns.14567
How is the Self-Guided Electronic Safety Plan Intervention different from other treatments for suicide prevention?
What is the purpose of this trial?
Suicide is a leading cause of death for youth 10-24, and nearly ¼ of adolescents report nonfatal suicidal thoughts and behaviors (STB). However, traditional interventions (e.g., multi-session therapy protocols) are contingent upon (1) access to treatment, (2) involvement of parents/guardians (hereafter parents), and (3) disclosure of risk to treatment providers. Unfortunately, adolescents are frequently hesitant to disclose STB to healthcare providers and parents for reasons including shame, stigma, and fear of hospitalization, with even lower rates of disclosure among queer youth-including those with diverse genders and sexualities- who are at disproportionately high risk for STB. Related to these concerns, most youth at risk for suicide, as well as other mental health challenges, do not access any mental healthcare. Self-guided, brief digital interventions may be a powerful adolescent suicide prevention tool. With their relative accessibility-they can be completed privately, at home, for at no cost-such interventions are well-suited for youth not accessing traditional care. Thus, effective digital adaptation of brief suicide prevention interventions is a promising frontier for adolescent suicide prevention.A strong candidate for digital adaptation is the Safety Planning Intervention (SPI), a brief (\~5-10 minute) single-session intervention shown to significantly reduce STB in adults. In the SPI, people at risk for suicide receive brief education about suicidal thoughts and crises before developing a personalized, one-page plan with skills and resources to use during future suicide crises, when it is difficult to think clearly. There is strong evidence across several randomized control trials (RCTs) that SPI reduce suicidal behaviors in adults compared to those who received treatment as usual. Despite widespread use in outpatient and acute clinical settings across ages, there is a paucity of adequately-powered RCTs testing whether the SPI (in any format) reduces STB in adolescents.Emerging evidence supports the SPI can work well in digital format among adolescents. In qualitative studies, adolescents with a history of STBs reported that they would be comfortable using a digital safety plan and feel it would be helpful to them in a crisis, emphasizing easy access and customizability as useful features. Building on this work, I created a digital, self-guided SPI specifically for use in online studies of high-risk adolescents. Preliminary research (approved by DU IRB# 1505797) suggests that youth find this self-guided digital SPI "very helpful" and nearly half actually use the safety plan in the next month. Moreover, using a standardized coding system, quality of self-guided safety plans mirrored the quality seen in clinician-guided, adult SPI. However, it remains unclear whether the SPI in any format can reduce STB in adolescents.This project will test the ability of a self-guided SPI, compared to a suicide psychoeducational control intervention, to increase self-efficacy to avoid suicidal behaviors and to reduce suicidal thoughts and suicidal behaviors in adolescents over a 3-month follow-up period. The investigators hypothesize that compared to the control condition, adolescents who receive the SPI will report greater self-efficacy to avoid suicidal action and reduced STB at the 3-month follow-up assessment. If hypotheses are supported, this study will provide strong, high-quality evidence in favor of the potential of highly accessible, digital self-guided SPIs to prevent suicidal behavior in adolescents. In this case, distribution of such an intervention at scale could be a powerful tool for reducing STBs in adolescents.
Research Team
Kathryn R Fox, PhD
Principal Investigator
University of Dener
Eligibility Criteria
This trial is for English-reading adolescents in the US with internet access who've had suicidal thoughts in the past month and a suicide attempt within the last year, or at least five days of such thoughts over the past year. It excludes those with disabilities preventing computer use or suspected fraudulent participants.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment and Randomization
Participants complete a baseline survey and are randomized to either the electronic self-guided intervention or psychoeducational control intervention
Intervention
Participants receive either the self-guided electronic safety plan or psychoeducational control intervention
Follow-up
Participants are monitored for suicidal thoughts and behaviors and other key outcomes over a 3-month period
Treatment Details
Interventions
- Self-Guided Electronic Safety Plan Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Denver
Lead Sponsor