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

Suicide Clinical Trial

— IAMSAFE  

Official title:

Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Multi-site Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225661
• Other study ID #: REB1000056892
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: Daphne Korczak, MD
• Phone: 416-813-8923
• Email: daphne.korczak[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: September 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital - Alberta Health Services & University of Calgary	Calgary	Alberta
Canada	McMaster Children's Hospital - Hamilton Health Sciences	Hamilton	Ontario
Canada	Trillium Health Partners	Mississauga	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR), SickKids Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Columbia-Suicide Severity Rating Scale (C-SSRS)	The Columbia-Suicide Severity Rating Scale is an interviewer-administered measure used to assess intensity of suicidal ideation and severity of suicidal behavior. Questions 1-5 (Ideation Severity Subscale) gage five types of ideation of increasing severity, scoring presence/absence of any suicidal ideation yes or no. The most severe ideation endorsed (1-5) becomes the score for this section. The Intensity of Ideation Subscale sums 5 items endorsed. Sums range from 2 to 25, with higher scores indicating more intense ideation. The Suicidal Behavior Subscale scores 4 types of suicidal behaviors; yes or no and identify categorical occurrence and density of actual, interrupted, aborted attempts and preparatory behaviors and distinguish suicidal and non-suicidal self injurious behavior.	Baseline, 6 weeks, 24 weeks
Secondary	Suicidal Ideation Questionnaire-Jr (SIQ-Jr)	The Suicidal Ideation Questionnaire-Jr (SIQ-Jr) measures intensity of suicidal ideation. The SIQ-Jr is a 15-item self-report questionnaire that assesses suicidal thoughts on a 7-point scale. Scores range from 0 to 90, with higher scores indicative of more severe suicidal ideation.	Baseline, 6 weeks, 24 weeks
Secondary	Schedule for Affective Disorders and Schizophrenia Depression Rating Scale (KSADS-DEPc)	Semi-structured interviewer-administered diagnostic measure designed for use with children and adolescents. Youth are asked about past month depression symptoms and suicidality to determine the presence or absence of a diagnosis of depression.	Baseline, 6 weeks, 24 weeks
Secondary	Screen for Child Anxiety Related Disorders (SCARED)	Measure of youth anxiety symptoms by self-report. There are 41 items in the measure. Scores range from 0-82, with higher values indicating greater anxiety symptoms.	Baseline, 6 weeks, 24 weeks
Secondary	Centre for Epidemiological Studies Depression Scale for Children (CES-DC)	Measure of youth depressive symptoms by self-report. There are 20 items in the measure. Total scores range from 0-60, with higher values indicating greater depressive symptoms.	Baseline, 6 weeks, 24 weeks
Secondary	Life Problems Inventory (LPI)	Measure of four core problem areas of borderline personality disorder by youth self-report. There are 60 items in the measure. Scores range from 60-300, with higher values indicating worse symptoms.	Baseline, 6 weeks, 24 weeks
Secondary	Columbia Impairment Scale (CIS)	Measure to assess global functioning and impairment by self- and parent- report. There are 13 items in the measure. Scores range from 0-52, with higher scores indicating greater impairment.	Baseline, 6 weeks, 24 weeks
Secondary	Conflict Behaviour Questionnaire (CBQ)	The CBQ is a 20-item self- and parent-report instrument that assesses aspects of the parent-child relationship including communication and conflict within the relationship. One measure is completed for each specific child-parent relationship. Scores range from 0-20, with higher scores indicating greater conflict.	Baseline, 6 weeks, 24 weeks
Secondary	Cost-Effectiveness Ratio	Cost effectiveness will be expressed as the incremental cost-effectiveness ratio, calculated by dividing the incremental costs between study arms by the incremental change in SREs per participant between baseline and 6 months. Data regarding directs and indirect costs incurred by youth and caregivers will be collected using an interviewer-administered survey developed by the study team. Cost-effectiveness will be determined as funding allows. Direct costs (intervention, medication, health services use) will be collected from investigators and participants. Indirect costs will include out-of-pocket expenses and productivity losses experienced by participants and their caregivers	Baseline, 6 weeks, 24 weeks
Secondary	Treatment Fidelity (Adherence and Competence) to the SAFE Intervention	Adherence to the core components of the intervention will be assessed using the Fidelity Treatment Checklist, a 10-item independent rater- and therapist-rated measure developed for the SAFE intervention based on existing measures of individual therapy and family therapy implementation fidelity. Scores range from 0-20, with higher scores indicating greater fidelity.	Baseline, 6 weeks, 24 weeks