Self-Guided Electronic Safety Plan for Suicide Prevention

(Project SAFER Trial)

Overseen By Juno Pinder, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Denver

Disqualifiers: Disability, Not in US, Fraudulent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a self-guided digital safety plan can help teens reduce suicidal thoughts and behaviors. The plan offers a quick, personalized strategy for handling crises and is tested against a standard educational program about suicide resources. It targets teens who have recently experienced suicidal thoughts or attempts and have internet access. The goal is to empower teens to manage crises independently, providing a private, accessible alternative to traditional therapy. As an unphased trial, this study offers teens a unique opportunity to explore innovative, self-guided support strategies for crisis management.

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 prior data suggests that this self-guided electronic safety plan is safe for adolescents?

Research has shown that self-guided digital safety plans can be safe and helpful for individuals with suicidal thoughts. Studies have found that these digital plans improve coping, which can lead to fewer suicidal thoughts. Users report finding them useful in a crisis due to their easy access and personalization.

One study examined a digital safety plan app and found it effective in reducing emergency room visits for suicidal behavior. This suggests the plan might help individuals manage their thoughts and actions better.

However, while these plans work well for adults, some research indicates they might not always reduce suicidal thoughts and behaviors in teenagers in crisis. Overall, these digital safety plans are considered safe and could be a helpful tool, especially since they can be used privately and at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Self-Guided Electronic Safety Plan for suicide prevention because it offers a new way for individuals to manage their mental health independently. Unlike traditional therapy sessions or hotline support, this intervention is digital and self-directed, giving users the flexibility to access help anytime, anywhere. It empowers individuals by providing them with personalized strategies to handle crises, fostering a sense of autonomy and control, which can be crucial in preventing suicide.

What evidence suggests that the Self-Guided Electronic Safety Plan Intervention could be effective for reducing suicidal thoughts and behaviors in adolescents?

Studies have shown that digital safety plans can greatly reduce suicidal thoughts and actions in adults. New evidence suggests these plans work well for teenagers too. For example, teens with suicidal thoughts reported feeling comfortable using digital safety plans and found them helpful during tough times. Early research indicates that almost half of the young people who used a self-guided digital safety plan found it "very helpful" and used it within a month. This trial will evaluate the effectiveness of a Self-Guided Electronic Safety Plan Intervention, which could be a promising tool for preventing suicidal behavior in teenagers. ^{1 2 3 6 7}

Who Is on the Research Team?

Kathryn R Fox, PhD

Principal Investigator

University of Dener

Are You a Good Fit for This Trial?

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

Internet access

Able to read and write in English

I have thought about suicide recently and attempted it in the last year.

Exclusion Criteria

Disability that interferes with the ability to complete the study on a computer

Not located in the US

Response that indicates bot or fraudulent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Online eligibility survey

Baseline Assessment and Randomization

Participants complete a baseline survey and are randomized to either the electronic self-guided intervention or psychoeducational control intervention

30 minutes

Online

Intervention

Participants receive either the self-guided electronic safety plan or psychoeducational control intervention

30 minutes

Online

Follow-up

Participants are monitored for suicidal thoughts and behaviors and other key outcomes over a 3-month period

3 months

Online follow-up assessments at 1.5 months and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Self-Guided Electronic Safety Plan Intervention

Trial Overview

The study compares two digital interventions: a control group receiving psychoeducation about suicide crisis resources and an experimental group using a self-guided electronic Safety Plan Intervention (SPI) to see if it helps prevent suicidal behavior over three months.

How Is the Trial Designed?

Group I: Self-Guided Electronic Safety Plan Intervention Experimental Treatment 1 Intervention

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

Group II: Psychoeducation about Suicide Crisis Resources (Control Intervention) Active Control 1 Intervention

Participants in this arm are assigned to the active control intervention

Who Is Running the Clinical Trial?

University of Denver

Lead Sponsor

Trials

25

Recruited

10,600+

Published Research Related to This Trial

MYPLAN is a mobile application developed to help individuals at risk of suicide create personalized safety plans, making it more accessible than traditional paper versions.

Since its launch in 2013, MYPLAN has been positively received, with nearly 8,000 downloads in Denmark and Norway, indicating its potential utility in supporting at-risk individuals, especially among younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MYPLAN - A Mobile Phone Application for Supporting People at Risk of Suicide. Skovgaard Larsen, JL., Frandsen, H., Erlangsen, A.[2022]

This trial will assess the effectiveness of a mobile app (MyPlan) for safety planning in reducing suicidal ideation compared to a traditional paper safety plan, involving 546 participants from Danish Suicide Prevention Clinics over a 12-month period.

Both groups will receive standard psychosocial care, allowing researchers to determine if the app can enhance the support provided by traditional safety plans in preventing self-harm and suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MYPLAN -mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial. Andreasson, K., Krogh, J., Bech, P., et al.[2022]

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

Safety planning is an effective evidence-based practice that can significantly reduce suicidal behaviors, highlighting its importance in mental health care.

Integrating safety plans into electronic patient portals at health centers, like the Institute for Family Health, offers a promising method to enhance safety planning efforts and potentially save lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Safety Plans for Suicidal Patients Into Patient Portals: Challenges and Opportunities. Little, V., Neufeld, J., Cole, AR.[2019]

A 1-hour virtual training significantly improved clinicians' knowledge and self-efficacy in using electronic safety plans for suicide prevention, with lasting effects observed at a 6-month follow-up.

Among clinicians working with suicidal youth, 81% attempted to use the electronic safety plan template, and 63% completed it, indicating that this training can enhance the implementation of safety planning in community settings despite some challenges like technology issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Suicide Safety Planning Training on Clinician Knowledge, Self-Efficacy, and Use of Safety Plans in Community Mental Health Clinics. Whitmyre, ED., Esposito-Smythers, C., Goldberg, DG., et al.[2023]

A self-administered, Web-based safety planning application was developed and tested with 30 suicidal patients, showing strong usability ratings and enabling 90% of participants to complete at least 5 out of 6 safety planning steps.

Participants reported a significant decrease in suicidal ideation intensity after using the application, with pre-application scores averaging 5.11 and post-application scores averaging 4.46, indicating the potential effectiveness of this tool in enhancing coping abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer Administered Safety Planning for Individuals at Risk for Suicide: Development and Usability Testing. Boudreaux, ED., Brown, GK., Stanley, B., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10189833/

Effectiveness of Suicide Safety Planning Interventions

Evidence across a range of studies indicates that SSP is effective for reducing suicide behavior (SB) and ideation (SI).

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165178124000350

Digital safety plan effectiveness and use: Findings from a ...

Among users of a self-guided safety planning app, increases in suicide-related coping uniquely predicted decreases in suicidal ideation. · App-related variables ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12186861/

Impact of Digital Safety Plan Activation on Subsequent ...

This study evaluated the effectiveness of a digital safety plan, delivered through the MeMind app, in reducing ED visits associated with suicidal behavior.

4.

bmchealthservres.biomedcentral.com

bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11739-w

insights from a randomized control trial of crisis response plan ...

In a recently published study [21], it was found that both CRP and self-led SPI were effective in reducing suicide ideation. Follow-up data ...

5.

thelancet.com

thelancet.com/journals/landig/article/PIIS2589-7500(19)30199-2/fulltext

Suicide prevention using self-guided digital interventions

We found that, overall, digital interventions are effective for reducing suicidal ideation, and we found encouraging evidence for the superior ...

6.

jamanetwork.com

jamanetwork.com/journals/jamapediatrics/fullarticle/2834286

Safety Planning Interventions for Suicide Prevention in ...

Results of this meta-analysis, however, suggest that in contrast to findings in adults, SPIs do not decrease SITBs for adolescents in crisis.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11587818/

Accessibility and Utility of an Electronic Self-Guided Safety ...

Electronic, self-guided safety plan interventions (e-SPI) represent a new, more accessible application of a suicide prevention tool. We tested ...