Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour

NCT ID: NCT06225661

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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This is a Multi-site Randomized Controlled Trial of a patient- and family-centered suicide prevention intervention added to usual care (SAFE + UC) for adolescents aged 12 to 17 years who present to the Emergency Department (ED) with suicidal ideation or suicide risk behaviours. The investigators will determine whether the SAFE + UC intervention is more effective than enhanced usual care (telephone navigation + UC) in reducing suicide-related behaviors in 330 youth at high-risk of suicide across Canadian sites.

SAFE + UC is a 6-week, standardized, manualized outpatient program that teaches participants to the skills to manage suicidal thoughts and impulses effectively. The family component addresses conflictual relationships that may be present in the family as well as improving family communication.

Telephone navigation (NAV) + UC consists of up to 6 weekly telephone calls to ensure that the participant has connected with community resources suggested by the ED team and provide additional resources as needed.

Conditions

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Suicide Suicide Prevention Suicidal Ideation Self-Injurious Behavior Behavioral Symptoms Suicide, Attempted Suicide and Self-harm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Study investigators and outcome assessors are blinded to allocation assignment.

Study Groups

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SAFE Intervention

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

Group Type EXPERIMENTAL

SAFE Intervention

Intervention Type BEHAVIORAL

Manualized individual youth and family psychotherapeutic intervention. Weekly individual and family sessions with a therapist for 6 weeks. Participants will continue to receive usual care.

NAV (Telephone Navigation)

This group will receive telephone-based case navigation.

Group Type ACTIVE_COMPARATOR

NAV (Telephone Navigation)

Intervention Type BEHAVIORAL

Weekly telephone contact with parents regarding participant health care utilization. Referrals to community mental health resources provided as needed. Participants will continue to receive usual care.

Interventions

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SAFE Intervention

Manualized individual youth and family psychotherapeutic intervention. Weekly individual and family sessions with a therapist for 6 weeks. Participants will continue to receive usual care.

Intervention Type BEHAVIORAL

NAV (Telephone Navigation)

Weekly telephone contact with parents regarding participant health care utilization. Referrals to community mental health resources provided as needed. Participants will continue to receive usual care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Youth presenting in the Emergency Department with SIQ-Jr score ≥ 31,
* Has a participating parent or caregiver who is able to communicate easily in English, or is willing to communicate using a hospital-organized translator,
* Between the ages 12-17 years old,
* Living in the catchment area of one of the three hospital sites and access to a telephone.

Exclusion Criteria

* Score of 3 on KSADS screen for current psychosis or elevated mood
* Moderate to severe intellectual disability, and/or autism based on clinical chart.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

SickKids Foundation

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Daphne Korczak

Associate Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alberta Children's Hospital - Alberta Health Services & University of Calgary

Calgary, Alberta, Canada

Site Status

McMaster Children's Hospital - Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Trillium Health Partners

Mississauga, Ontario, Canada

Site Status

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB1000056892

Identifier Type: -

Identifier Source: org_study_id

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