Suicide AttemptProject SAFERNCT06868407
Electronic, Self-Guided Safety Plan in Adolescents: Project SAFER
A study testing Experimental: Self-Guided Electronic Safety Plan Intervention in people with Suicide Attempt and Suicide Ideation, run by University of Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Suicide Attempt, Suicide Ideation
- What is being tested?
- Experimental: Self-Guided Electronic Safety Plan Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2025to 5 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- disability that interferes with the ability to complete the study on a computer
- not in US
- response that indicates bot or fraudulent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Juno Pinder, MA contact
United States1 site
University of Denver
Denver, Colorado, 80210
Kathryn Fox, PhD, 3015202715, kathryn.fox@du.edu
Juno Pinder, MA, juno.pinder@du.edu
About this study
Official title: Randomized Control Trial of Electronic, Self-Guided Safety Plan in Adolescents: Project SAFER
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.
Read more
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.
Read the 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:
- 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.
- 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
- Being tested
- Psychoeducation about Suicide Crisis Resources (Control Intervention), Experimental: Self-Guided Electronic Safety Plan Intervention
- Keywords
- adolescent, suicide, safety plan intervention, RCT
- Medical subject headings
- Suicide, Attempted, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation about Suicide Crisis Resources (Control Intervention)Behavioural
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 InterventionBehavioural
Also called E-SPI
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Guided Electronic Safety Plan Intervention | Experimental | Participants in this arm are assigned to the electronic, self-guided safety plan. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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))
Measured: immediately post intervention AND across 3-month follow-up period
Secondary outcomes (2)
Days of suicide ideation over 3 month period
Self-reported days of suicide ideation over the 3 month follow-up period using the SITBI-R (Fox et al., 2020)
Measured: 3 months
Number of participants reporting suicidal behaviors over follow-up
Number of participants reporting engagement (presence/absence) in suicidal behaviors (suicide attempt, aborted attempt, interrupted attempt) over the 3 month follow-up period using the SITBI-R (Fox et al., 2020)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start8 Mar 2025 (estimated)
- Primary completion5 Aug 2025 (estimated)
- Study completion5 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide AttemptStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 fashion to either the electronic, self-guided safety plan or the psychoeducational control.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Fox, University of Denver
- Investigators
- Kathryn R Fox, PhD, Principal investigator, University of Dener
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868407
- Sponsor's protocol ID
- 2200661-2
- Other IDs
- 2200661-2
- Acronym
- Project SAFER
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be collected online (single site), via Qualtrics, an encrypted and HIPAA-compliant platform. Our Qualtrics Surveys will be shared across study team members at University of Denver. Recruitment and participation will be monitored by members of the study team. When the study is completed: Data will downloaded from Qualtrics and will be stored on HIPAA compliant servers (smb://shares.du.edu/research/AHSS Psychology/Fox Lab) rather than individual computers. De-identified data (data WITHOUT email addresses, phone numbers, etc) will be kept indefinitely and may be made available to other researchers for other studies following the completion of this research study (e.g., on osf.io). For example, when the research is completed, anonymized data may be saved for use in future research and may be posted online (e.g., posted on osf.io).
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Electronic, Self-Guided Safety Plan in Adolescents: Project SAFER
- ClinicalTrials.gov ID
- NCT06868407
- Acronym / sponsor ID
- Project SAFER / 2200661-2
- Conditions
- Suicide Attempt, Suicide Ideation
- Keywords
- adolescent, suicide, safety plan intervention, RCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of DenverUniversity, hospital or other
- Study start
- 8 Mar 2025 (estimated)
- Primary completion
- 5 Aug 2025 (estimated)
- Study completion
- 5 Aug 2025 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 fashion to either the electronic, self-guided safety plan or the psychoeducational control.
| Arm | Type | Receives |
|---|---|---|
| Self-Guided Electronic Safety Plan Intervention | Experimental | Behavioral: Experimental: Self-Guided Electronic Safety Plan InterventionParticipants in this arm are assigned to the electronic, self-guided safety plan. |
| Psychoeducation about Suicide Crisis Resources (Control Intervention) | Active comparator | –Participants in this arm are assigned to the active control intervention |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- disability that interferes with the ability to complete the study on a computer
- not in US
- response that indicates bot or fraudulent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | – |
| Experimental: Self-Guided Electronic Safety Plan InterventionAlso: E-SPIThis 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. | Behavioural | Self-Guided Electronic Safety Plan Intervention |
Primary outcome
Average scores on self-efficacy to avoid future suicidal action score
Time frame: Post-intervention AND across 3-month follow-up period
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)
Average perceived suicide-related coping capacity
Time frame: immediately post intervention AND across 3-month follow-up period
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))
2 secondary outcomes
Days of suicide ideation over 3 month period
Time frame: 3 months
Number of participants reporting suicidal behaviors over follow-up
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Yes. All data will be collected online (single site), via Qualtrics, an encrypted and HIPAA-compliant platform. Our Qualtrics Surveys will be shared across study team members at University of Denver. Recruitment and participation will be monitored by members of the study team. When the study is completed: Data will downloaded from Qualtrics and will be stored on HIPAA compliant servers (smb://shares.du.edu/research/AHSS Psychology/Fox Lab) rather than individual computers. De-identified data (data WITHOUT email addresses, phone numbers, etc) will be kept indefinitely and may be made available to other researchers for other studies following the completion of this research study (e.g., on osf.io). For example, when the research is completed, anonymized data may be saved for use in future research and may be posted online (e.g., posted on osf.io).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juno Pinder, MA contact
Kathryn R Fox, PhD principal investigator
University of Dener
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Self-Guided Electronic Safety Plan Intervention in people with Suicide Attempt and Suicide Ideation, run by University of Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn R Fox, PhD (301-520-2715, kathryn.fox@du.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average scores on self-efficacy to avoid future suicidal action score (time frame: Post-intervention AND across 3-month follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.