SAFE Intervention + Telephone Navigation for Suicide Prevention

(IAMSAFE Trial)

Not currently recruiting at 3 trial locations

Overseen By Jacky Au, BSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Psychosis, Elevated mood, Intellectual disability, Autism

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new approach for preventing suicide in Canadian youth at high risk. It compares two types of support: a family-centered program (SAFE Intervention) and a phone-based help system (NAV). The goal is to determine which method more effectively reduces suicidal behaviors. The trial seeks young people who have visited the emergency room for suicidal thoughts and live near one of the participating hospitals. Participants must have a parent or caregiver who can communicate in English or with a translator. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future suicide prevention strategies.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the SAFE Intervention and NAV are safe for youth at high risk of suicide?

Research has shown that safety planning interventions, such as the SAFE Intervention, are generally well-received. Studies have found they effectively reduce suicidal behavior and thoughts. One study revealed that individuals using a digital safety plan were 50% less likely to attempt suicide later. This suggests the SAFE Intervention may be helpful and safe to use.

Specific study data on the NAV (Telephone Navigation) component is not available. However, the trial's "Not Applicable" phase designation indicates the treatments are considered low-risk, often suggesting they have been proven safe in other contexts or similar uses. The main focus is on their effectiveness, rather than identifying new safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SAFE Intervention and Telephone Navigation because they offer a fresh approach to suicide prevention. Unlike traditional methods that often rely on medication or in-person therapy, the SAFE Intervention focuses on youth and family-based support, which can foster a more supportive environment for teens at risk. Meanwhile, the Telephone Navigation (NAV) offers a convenient, accessible way to guide individuals through the mental health care process, potentially reaching those who might not seek in-person help. These approaches could make suicide prevention more personalized and accessible, addressing gaps in current treatments.

What evidence suggests that this trial's treatments could be effective for suicide prevention?

Research shows that the SAFE Intervention, a treatment in this trial, yields promising results in reducing behaviors related to suicide. Studies have demonstrated that safety planning methods like SAFE successfully lower the number of suicide attempts and thoughts. Specifically, one study found a 5% drop in suicide attempts when using similar methods in emergency rooms. However, some research suggests these methods might not work as well for teenagers in crisis. The evidence supports SAFE as a helpful tool for preventing suicide, although its effectiveness can vary depending on the group. Another treatment arm in this trial involves NAV (Telephone Navigation), which researchers will compare to the SAFE Intervention to assess its effectiveness in suicide prevention. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Canadian youth at high risk of suicide who have shown suicidal behavior or thoughts, attempted suicide, self-harm, or are in an emergency situation due to these issues. Specific eligibility details were not provided.

Inclusion Criteria

I am between 12 and 17 years old.

Living in the catchment area of one of the three hospital sites and access to a telephone

Youth presenting in the Emergency Department with SIQ-Jr score ≥ 31

Exclusion Criteria

Moderate to severe intellectual disability, and/or autism based on clinical chart

Score of 3 on KSADS screen for current psychosis or elevated mood

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SAFE + UC intervention or NAV + UC intervention for 6 weeks

6 weeks

Up to 6 weekly visits (telephone or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NAV
• SAFE Intervention

Trial Overview The study tests a patient- and family-centered intervention called SAFE Intervention against enhanced usual care. It also includes NAV (Telephone Navigation) support. The goal is to see if these approaches reduce suicide-related behaviors more effectively.

How Is the Trial Designed?

Group I: SAFE Intervention Experimental Treatment 1 Intervention

This group will receive the SAFE individual youth and family-based intervention.

Group II: NAV (Telephone Navigation) Active Control 1 Intervention

This group will receive telephone-based case navigation.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

SickKids Foundation

Collaborator

Trials

10

Recruited

2,200+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

The National Suicide Prevention Lifeline implemented a comprehensive policy in 2012 aimed at effectively assisting callers at imminent risk of suicide, focusing on active engagement, active rescue, and collaboration with emergency services.

This policy was based on evidence and best practices, providing a standardized approach across crisis centers to improve intervention outcomes for individuals in crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping callers to the National Suicide Prevention Lifeline who are at imminent risk of suicide: the importance of active engagement, active rescue, and collaboration between crisis and emergency services. Draper, J., Murphy, G., Vega, E., et al.[2022]

The implementation of Applied Suicide Intervention Skills Training (ASIST) in crisis hotlines led to significant improvements in callers' feelings of depression, suicidal thoughts, and overall hopefulness, based on data from 1,507 monitored calls.

While ASIST training did not result in more thorough suicide risk assessments, it was associated with effective counselor interventions that helped callers explore reasons for living and connect with informal support, contributing to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Applied Suicide Intervention Skills Training on the National Suicide Prevention Lifeline. Gould, MS., Cross, W., Pisani, AR., et al.[2022]

The paper discusses various strategies for suicide intervention, highlighting the importance of effective support services in preventing suicide.

It outlines specific features of a service designed to assist individuals at risk, emphasizing the need for tailored interventions to address the unique needs of those experiencing suicidal thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide first aid. Moore, B.[2022]

The NavSTAR intervention, which includes Patient Navigation and motivational support, is being tested against standard care (TAU) for 400 hospitalized patients with substance use disorders to see if it reduces hospital readmissions and improves treatment adherence.

If successful, NavSTAR could significantly enhance post-discharge care for patients with comorbid substance use disorders, potentially leading to better health outcomes and reduced healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigation Services to Avoid Rehospitalization among Medical/Surgical Patients with Comorbid Substance Use Disorder: Rationale and Design of a Randomized Controlled Trial. Nordeck, CD., Welsh, C., Schwartz, RP., et al.[2022]

The SAFE VET intervention, which combines Safety Planning Intervention (SPI) with structured follow-up and monitoring, was found to be highly acceptable among 100 participants in five Department of Veterans Affairs medical center EDs.

Participants reported that the intervention was helpful in preventing further suicidal behavior and encouraging engagement in treatment, indicating its potential effectiveness in supporting individuals at high risk after an emergency department visit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Emergency Department Intervention and Follow-Up to Reduce Suicide Risk in the VA: Acceptability and Effectiveness. Stanley, B., Chaudhury, SR., Chesin, M., 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]

A study monitoring 2,611 calls to 14 crisis centers revealed significant variability in the quality and nature of suicide prevention interventions, highlighting the need for standardized practices.

Helpers often do not systematically assess suicide risk during calls, which may lead to missed opportunities for effective intervention and potential lives lost, emphasizing the importance of quality assurance in crisis intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing models of helper behavior to actual practice in telephone crisis intervention: a Silent Monitoring Study of Calls to the U.S. 1-800-SUICIDE Network. Mishara, BL., Chagnon, F., Daigle, M., et al.[2007]

In a study analyzing 491 crisis calls from 132 helpers across eight centers, it was found that crisis helpers successfully engaged callers in safety collaboration 76.4% of the time, highlighting the effectiveness of active intervention strategies.

Emergency services were dispatched without caller collaboration in 24.6% of cases, indicating that some individuals were at such high risk that immediate action was necessary, which underscores the importance of identifying imminent risk profiles for tailored interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping Callers to the National Suicide Prevention Lifeline Who Are at Imminent Risk of Suicide: Evaluation of Caller Risk Profiles and Interventions Implemented. Gould, MS., Lake, AM., Munfakh, JL., et al.[2022]

The concept of suicide intervention offers a more neutral approach compared to traditional suicide prevention, allowing for the possibility of supporting individuals who may see death as a valid option due to chronic distress.

This model challenges existing suicide prevention methods by addressing complex feelings about life and death, suggesting that for some individuals, a focus on the quality of life and the appropriateness of death may be necessary in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide: issues of prevention, intervention, and facilitation. Nelson, FL.[2022]

In a study of 395 hospitalized adults with substance use disorder, post-discharge telephonic navigation did not significantly reduce substance use compared to standard care, with both groups showing similar decreases in use after one month.

However, participants who completed all four navigation calls experienced a notable reduction in substance use, suggesting that consistent follow-up may enhance outcomes for some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of post-discharge navigation added to an inpatient addiction consultation for patients with substance use disorder; a randomized controlled trial. Wakeman, SE., Rigotti, NA., Herman, GE., et al.[2022]

A systematic review of five studies found that telephone-delivered interventions for individuals who attempted suicide did not significantly reduce the likelihood of further suicide attempts or completed suicides.

The use of crisis cards for patients who engaged in deliberate self-harm also showed no significant impact on reducing further self-harm incidents, suggesting that these telephone-based strategies may not be effective alternatives to in-person therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Telephone-Delivered Interventions Following Suicide Attempts: A Systematic Review. Noh, D., Park, YS., Oh, EG.[2018]

The pilot study involving 66 adolescents showed that the ASAP intervention, which includes a smartphone app for emotion regulation, did not significantly reduce suicide attempts post-discharge, but indicated a trend towards fewer attempts (16% vs. 31%).

Participants with a history of previous suicide attempts may benefit more from the ASAP intervention, suggesting that this program could be tailored for those at higher risk, and overall, the intervention and app were well-received by users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

As Safe as Possible (ASAP): A Brief App-Supported Inpatient Intervention to Prevent Postdischarge Suicidal Behavior in Hospitalized, Suicidal Adolescents. Kennard, BD., Goldstein, T., Foxwell, AA., 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/pii/S016517812400088X

The effectiveness of a suicide prevention program in ... In other words, the suicide rate in the intervention area decreased by 25% following the intervention. These results empirically substantiate suicide prevention ...

3. 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.

4. psnet.ahrq.gov psnet.ahrq.gov/innovation/suicide-prevention-emergency-department-population-ed-safe

Suicide Prevention in an Emergency Department Population In ED-SAFE 1, there was a 5% absolute reduction in suicide attempts between the treatment as usual and intervention phases. During the ...

5. sprc.org sprc.org/effective-prevention/comprehensive-approach

A Comprehensive Approach to Suicide Prevention The model above shows nine strategies that form a comprehensive approach to suicide prevention and mental health promotion.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11116169/

The effect of the SAFE intervention on post-discharge suicidal ... The rate of suicide attempt was 11,652 per 100,000 person-years at the SAFE site, while it was 10,530 at comparisons sites. No observable ...

7. mental.jmir.org mental.jmir.org/2025/1/e70253

Impact of Digital Safety Plan Activation on Subsequent ... This study found that participants who chose to activate a digital safety plan showed a 50% reduction in the likelihood of subsequent suicide- ...

8. library.samhsa.gov library.samhsa.gov/product/safe-t-suicide-assessment-five-step-evaluation-and-triage/pep24-01-036

SAFE-T Suicide Assessment Five Step Evaluation and Triage This resource gives a brief overview on conducting a suicide assessment using a five-step evaluation and triage plan.