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

NCT06868407 | Not Yet Recruiting

• 1 other identifier: 2200661-2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide Attempt; Suicide Ideation

Keywords

adolescent; suicide; safety plan intervention; RCT

Outcome Measures

Primary Outcomes (2)

• Average scores on self-efficacy to avoid future suicidal action score

  Responses to a question measuring self-efficacy to avoid future suicidal behavior: "If you have serious thoughts of killing yourself in the future, how confident are you that you WILL BE ABLE to keep yourself from attempting suicide?" (Czyz et al., 2016)

  Post-intervention AND across 3-month follow-up period

• Average perceived suicide-related coping capacity

  Average scores on a composite of 3 items from the Stanley et al. 2017 measure of suicide-related coping (i.e., I have several things I can do to get through a suicidal crisis, I do not think there is anything that I can do to help myself when I am feeling suicidal (R), I am at the mercy of my suicidal thoughts (R))

  immediately post intervention AND across 3-month follow-up period

Secondary Outcomes (2)

• Days of suicide ideation over 3 month period

  3 months

• Number of participants reporting suicidal behaviors over follow-up

  3 months

Study Arms (2)

Self-Guided Electronic Safety Plan Intervention

EXPERIMENTAL

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

Behavioral: Experimental: Self-Guided Electronic Safety Plan Intervention

Psychoeducation about Suicide Crisis Resources (Control Intervention)

ACTIVE COMPARATOR

Participants in this arm are assigned to the active control intervention

Interventions

Psychoeducation about Suicide Crisis Resources (Control Intervention) BEHAVIORAL

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.

Experimental: Self-Guided Electronic Safety Plan Intervention 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.

Also known as: E-SPI

Self-Guided Electronic Safety Plan Intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Denver: lead

Study Sites (1)

University of Denver

Denver, Colorado, 80210, United States

Location

MeSH Terms

Conditions

Suicide, Attempted; Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Kathryn R Fox, PhD

  University of Dener

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn R Fox, PhD

CONTACT

301-520-2715; kathryn.fox@du.edu

Juno Pinder, MA

CONTACT

juno.pinder@du.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Random assignment to condition will be conducted in a triple-masked manner. Participants will be masked to whether they received active treatment and investigators will be masked to which condition the participant is randomized to-as the randomization occurs automatically within the Qualtrics survey. Additionally, as the primary and secondary outcomes are self-report measures, we will not be utilizing an outcomes assessor (e.g. a clinical interviewer).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized in a 1:1 fashion to either the electronic, self-guided safety plan or the psychoeducational control.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 11, 2025
• Study Start: March 8, 2025
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 1 year after completing data collection OR upon submission of the manuscript to a peer-reviewed journal. The data will be available open access thereafter.
• Access Criteria: The de-identified data will be shared open access

Locations

US (1)