Electronic, Self-Guided Safety Plan in Adolescents: Project SAFER

NCT ID: NCT06868407

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-08
• Study Completion Date: 2025-08-05

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.

Conditions

Suicide Attempt; Suicide Ideation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Self-Guided Electronic Safety Plan Intervention

Participants in this arm are assigned to the electronic, self-guided safety plan.

Group Type: EXPERIMENTAL

Experimental: Self-Guided Electronic Safety Plan Intervention

Intervention Type: BEHAVIORAL

This is a modified version of the E-SPI first created by Methi and colleagues (2024) which was originally adapted from the six primary steps of the Stanely-Brown safety plan (identifying warning signs, internal coping strategies, social distractions, non-professional crisis contacts, professional crisis resources, suicidal means restriction). Modifications to the E-SPI were based on pilot-study participant feedback and feedback from a youth focus group. The intervention was updated in accordance with pilot-study participant feedback and feedback from subsequent youth interviews. Modification examples include updated instruction wording to reduce ambiguity, updated illustrations, and increased accessibility for participants with reading-based learning disabilities.

Psychoeducation about Suicide Crisis Resources (Control Intervention)

Participants in this arm are assigned to the active control intervention

Group Type: ACTIVE_COMPARATOR

No interventions assigned to this group

Interventions

Psychoeducation about Suicide Crisis Resources (Control Intervention)

The active control intervention includes psychoeducation about suicide crisis services, with a particular focus on breaking down myths and barriers to using suicide crisis services use.

Intervention Type: BEHAVIORAL

Experimental: Self-Guided Electronic Safety Plan Intervention

This is a modified version of the E-SPI first created by Methi and colleagues (2024) which was originally adapted from the six primary steps of the Stanely-Brown safety plan (identifying warning signs, internal coping strategies, social distractions, non-professional crisis contacts, professional crisis resources, suicidal means restriction). Modifications to the E-SPI were based on pilot-study participant feedback and feedback from a youth focus group. The intervention was updated in accordance with pilot-study participant feedback and feedback from subsequent youth interviews. Modification examples include updated instruction wording to reduce ambiguity, updated illustrations, and increased accessibility for participants with reading-based learning disabilities.

Intervention Type: BEHAVIORAL

Other Intervention Names

E-SPI

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Denver

OTHER

Sponsor Role: lead

Responsible Party

Kathryn Fox

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn R Fox, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Dener

Locations

University of Denver

Denver, Colorado, United States

Countries

United States

Central Contacts

Kathryn R Fox, PhD

Role: CONTACT

kathryn.fox@du.edu

301-520-2715

Juno Pinder, MA

Role: CONTACT

juno.pinder@du.edu

Facility Contacts

Kathryn Fox, PhD

Role: primary

kathryn.fox@du.edu

3015202715

Juno Pinder, MA

Role: backup

juno.pinder@du.edu

Other Identifiers

2200661-2

Identifier Type: OTHER

Identifier Source: secondary_id

2200661-2

Identifier Type: -

Identifier Source: org_study_id