Suicide Clinical Trial
— IAMSAFEOfficial title:
Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Multi-site Randomized Controlled 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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | Canadian Institutes of Health Research (CIHR), SickKids Foundation |
Canada,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04127292 -
Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome
|
N/A | |
Recruiting |
NCT06079853 -
Nurse Suicide: Physiologic Sleep Health Promotion Trial
|
N/A | |
Recruiting |
NCT05423483 -
Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents
|
Phase 2 | |
Completed |
NCT03272048 -
Identifying Effective Approaches to Counseling on Firearm Safety
|
N/A | |
Completed |
NCT05514587 -
Meaning of Life Questionnaire (MLQ) in Patients Admitted to the Crisis Centre (MSVCAC)
|
||
Enrolling by invitation |
NCT05639426 -
Preventing Youth Violence Through Building Equitable Communities
|
N/A | |
Completed |
NCT03703128 -
Suicide in People Aged 45-60: A Case-control Psychological Autopsy Study
|
||
Completed |
NCT03646903 -
Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk
|
N/A | |
Not yet recruiting |
NCT06349915 -
A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents
|
N/A | |
Not yet recruiting |
NCT05558332 -
Youth Nominated Support Team
|
N/A | |
Completed |
NCT02718248 -
Ottawa Suicide Prevention in Men Pilot Study
|
N/A | |
Completed |
NCT02094898 -
Ketamine for Depression and Suicide Risk
|
Phase 2 | |
Completed |
NCT01360736 -
A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)
|
N/A | |
Completed |
NCT01594138 -
Linguistic Characteristics of Suicidal Patients in the Emergency Department
|
N/A | |
Completed |
NCT02228044 -
Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment
|
N/A | |
Completed |
NCT00604097 -
Preventing Youth Suicide in Primary Care: A Family Model
|
Phase 3 | |
Completed |
NCT00387855 -
An Evaluation of the SOS (Suicide Prevention) Program
|
N/A | |
Recruiting |
NCT03519802 -
Evaluation of Cognitive Function in a Suicidal Crisis
|
||
Completed |
NCT05580757 -
Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
|
||
Recruiting |
NCT03030924 -
Wearable Suicidal Early Warning System for Adolescents
|