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

NCT06225661 | Active Not Recruiting

• 1 other identifier: REB1000056892
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Suicide Risk Events (SREs) throughout 6 months of study engagement

  Suicide attempts and unscheduled ED/hospital re-visits (including hospitalization) for SREs, or death by suicide during the 6-month follow up period. SREs will be determined by participant and caregiver report using validated questions regarding suicide attempts from the Columbia-Suicide Severity Rating Scale (C-SSRS).

  Baseline, 6 weeks, 24 weeks

Secondary Outcomes (10)

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Baseline, 6 weeks, 24 weeks

• Suicidal Ideation Questionnaire-Jr (SIQ-Jr)

  Baseline, 6 weeks, 24 weeks

• Schedule for Affective Disorders and Schizophrenia Depression Rating Scale (KSADS-DEPc)

  Baseline, 6 weeks, 24 weeks

• Screen for Child Anxiety Related Disorders (SCARED)

  Baseline, 6 weeks, 24 weeks

• Centre for Epidemiological Studies Depression Scale for Children (CES-DC)

  Baseline, 6 weeks, 24 weeks

Study Arms (2)

SAFE Intervention

EXPERIMENTAL

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

Behavioral: SAFE Intervention

NAV (Telephone Navigation)

ACTIVE COMPARATOR

This group will receive telephone-based case navigation.

Behavioral: NAV (Telephone Navigation)

Interventions

SAFE Intervention 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.

SAFE Intervention

NAV (Telephone Navigation) 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.

NAV (Telephone Navigation)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• SickKids Foundation: collaborator

Study Sites (4)

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

Calgary, Alberta, T2W 1S7, Canada

Location

McMaster Children's Hospital - Hamilton Health Sciences

Hamilton, Ontario, L8L 8E7, Canada

Location

Trillium Health Partners

Mississauga, Ontario, L5B 1B8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study investigators and outcome assessors are blinded to allocation assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 26, 2024
• Study Start: March 1, 2021
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)