Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 10:04 PM
Study NCT ID:
NCT06225661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2024-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Multi-site Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IAMSAFE
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: