Clinical trial NCT06225661: Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour
Official title: Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Multi-site Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Suicide Prevention
Suicidal Ideation
Self-Injurious Behavior
Behavioral Symptoms
Suicide, Attempted
Suicide and Self-harm
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: SickKids Foundation
First posted: 2024-01-26
Enrollment: 330
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Suicide Risk Events (SREs) throughout 6 months of study engagement
timeFrame: Baseline, 6 weeks, 24 weeks
Secondary outcomes:
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Suicidal Ideation Questionnaire-Jr (SIQ-Jr)
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Schedule for Affective Disorders and Schizophrenia Depression Rating Scale (KSADS-DEPc)
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Screen for Child Anxiety Related Disorders (SCARED)
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Centre for Epidemiological Studies Depression Scale for Children (CES-DC)
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Life Problems Inventory (LPI)
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Columbia Impairment Scale (CIS)
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Conflict Behaviour Questionnaire (CBQ)
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Cost-Effectiveness Ratio
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Treatment Fidelity (Adherence and Competence) to the SAFE Intervention
timeFrame: Baseline, 6 weeks, 24 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital - Alberta Health Services & University of Calgary
state: Alberta
city: Hamilton
country: Canada
facility: McMaster Children's Hospital - Hamilton Health Sciences
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: