Clinical trial NCT06868407: Electronic, Self-Guided Safety Plan in Adolescents: Project SAFER
Official title: Randomized Control Trial of Electronic, Self-Guided Safety Plan in Adolescents: Project SAFER
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide Attempt
Suicide Ideation
Keywords: adolescent
suicide
safety plan intervention
RCT
Lead sponsor: University of Denver
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in a 1:1 fashion to either the electronic, self-guided safety plan or the psychoeducational control.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Participants will be recruited via advertisements posted primarily online to web-based forums and social media (e.g., discord, Instagram). Digital recruitment flyers will also be distributed to youth-serving organizations and mental health clinics to share with the adolescents they serve. In communications with participants, the investigators will call this study "Project SAFER." Those who see study ads and are interested in participating will be directed to click the hyperlink directing them to Qualtrics where they will complete an eligibility survey assessing inclusion/exclusion criteria for the study (see attached).

Individuals who qualify will be shown a study assent form delineating all study components. Those who "agree" to participate will then complete a brief quiz to ensure they understand the risks and benefits of participating. Individuals who do not qualify for the studies will be notified that they do not qualify, and they will be provided with electronic mental health resources. Participants will be told they can take the quiz up to 3 times before they will be told they do not qualify.

All aspects of the study be completed online, via Qualtrics.

There are two primary parts of the study:

1. Part 1 (\~30 minutes): Participants will complete the baseline survey, before being randomized to either the electronic self-guided intervention or psychoeducational control intervention. Finally, participant will post intervention measures.
2. Part 2 (\~15 minutes): Three months after part 1, participants will be contacted to complete Part 2, assessing suicidal thoughts and behaviors and other key outcomes, since completing Part 1.

Halfway through the follow-up period (1.5 months after completing Part 1), participants will receive a follow-up message reminding them about their safety plan (treatment group) or resource list (control group). Finally, all participants in the control group will be offered the Safety Plan at the end of Part 2.

Eligibility criteria: Inclusion Criteria:

* Able to read and write in English
* Internet access,
* Past-month suicidal thoughts AND a past-year suicide attempt OR at least 5 days of suicidal thoughts in the past year.

Exclusion Criteria:

* disability that interferes with the ability to complete the study on a computer
* not in US
* response that indicates bot or fraudulent

Primary outcomes:
measure: Average scores on self-efficacy to avoid future suicidal action score
timeFrame: Post-intervention AND across 3-month follow-up period
measure: Average perceived suicide-related coping capacity
timeFrame: immediately post intervention AND across 3-month follow-up period
Secondary outcomes:
measure: Days of suicide ideation over 3 month period
timeFrame: 3 months
measure: Number of participants reporting suicidal behaviors over follow-up
timeFrame: 3 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Denver
state: Colorado
Study officials:
affiliation: University of Dener
name: Kathryn R Fox, PhD
role: PRINCIPAL_INVESTIGATOR
References: