SAFE Intervention + Telephone Navigation for Suicide Prevention

(IAMSAFE Trial)

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

330 Participants Needed

Trial Summary

What is the purpose of this trial?

Suicide is the leading cause of death due to illness among Canadian youth, claiming more lives than any medical illness, including cancer. Suicide prevention is possible, and early intervention is needed. The investigators will examine the effectiveness of a previously-piloted, ED-based suicide prevention intervention, across Canadian sites, using a randomized clinical trial design. The investigators will determine whether the patient- and family-centered intervention is more effective than enhanced usual care in reducing suicide-related behaviors in 330 youth at high-risk of suicide.

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 data supports the effectiveness of the SAFE Intervention + Telephone Navigation for Suicide Prevention treatment?

Research shows that telephone-delivered interventions and safety planning can help reduce suicidal thoughts and behaviors. Studies indicate that these approaches can decrease feelings of depression and hopelessness, and improve treatment engagement, making them promising components for suicide prevention. ^{1 2 3 4 5}

Is the SAFE Intervention + Telephone Navigation generally safe for humans?

The research articles do not provide specific safety data for the SAFE Intervention + Telephone Navigation, but they do not report any safety concerns or adverse effects related to the intervention in the studies mentioned. ^{5 6 7 8 9}

How is the SAFE Intervention + Telephone Navigation treatment unique for suicide prevention?

The SAFE Intervention + Telephone Navigation treatment is unique because it combines a safety planning intervention (SPI) with telephone follow-up, providing ongoing support and monitoring for individuals at risk of suicide. This approach is flexible, allowing for both in-person and remote delivery, and is designed to improve treatment engagement and reduce hospitalizations. ^{4 7 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Telephone-Delivered Interventions Following Suicide Attempts: A Systematic Review. [2018]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Impact of Applied Suicide Intervention Skills Training on the National Suicide Prevention Lifeline. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]

5. England 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. [2022]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

An Emergency Department Intervention and Follow-Up to Reduce Suicide Risk in the VA: Acceptability and Effectiveness. [2022]

8. England 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. [2022]

9. England 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. [2022]

10. England 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. [2007]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. Australia pubmed.ncbi.nlm.nih.gov

Suicide first aid. [2022]