SuicideIAMSAFENCT06225661
Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour
A study testing SAFE Intervention and NAV (Telephone Navigation) in people with Suicide and Suicide Prevention, run by The Hospital for Sick Children at 4 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Suicide, Suicide Prevention, Suicidal Ideation
- What is being tested?
- SAFE Intervention and NAV (Telephone Navigation)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Mar 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Score of 3 on KSADS screen for current psychosis or elevated mood
- Moderate to severe intellectual disability, and/or autism based on clinical chart.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Alberta Children's Hospital - Alberta Health Services & University of Calgary
Calgary, Alberta, T2W 1S7
McMaster Children's Hospital - Hamilton Health Sciences
Hamilton, Ontario, L8L 8E7
Trillium Health Partners
Mississauga, Ontario, L5B 1B8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official 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.
Read the 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.
- Conditions
- Suicide, Suicide Prevention, Suicidal Ideation, Self-Injurious Behavior, Behavioral Symptoms, Suicide, Attempted
- Being tested
- SAFE Intervention, NAV (Telephone Navigation)
- Medical subject headings
- Suicide, Suicide Prevention, Suicidal Ideation, Self-Injurious Behavior, Behavioral Symptoms, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFE InterventionBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SAFE Intervention | Experimental | This group will receive the SAFE individual youth and family-based intervention. Receives: Behavioral: SAFE Intervention |
| NAV (Telephone Navigation) | Active comparator | This group will receive telephone-based case navigation. Receives: Behavioral: NAV (Telephone Navigation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 6 weeks, 24 weeks
Secondary outcomes (10)
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.
Measured: Baseline, 6 weeks, 24 weeks
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.
Measured: Baseline, 6 weeks, 24 weeks
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.
Measured: Baseline, 6 weeks, 24 weeks
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.
Measured: Baseline, 6 weeks, 24 weeks
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.
Measured: Baseline, 6 weeks, 24 weeks
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.
Measured: Baseline, 6 weeks, 24 weeks
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.
Measured: Baseline, 6 weeks, 24 weeks
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.
Measured: Baseline, 6 weeks, 24 weeks
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
Measured: Baseline, 6 weeks, 24 weeks
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.
Measured: Baseline, 6 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Mar 2021
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), SickKids Foundation
- Responsible party
- Principal investigator, Daphne Korczak, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225661
- Sponsor's protocol ID
- REB1000056892
- Acronym
- IAMSAFE
- Status last verified
- Sep 2025
- First submitted
- 11 Jan 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Multi-site Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06225661
- Acronym / sponsor ID
- IAMSAFE / REB1000056892
- Conditions
- Suicide, Suicide Prevention, Suicidal Ideation, Self-Injurious Behavior, Behavioral Symptoms, Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), SickKids Foundation
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAFE Intervention | Experimental | Behavioral: SAFE InterventionThis group will receive the SAFE individual youth and family-based intervention. |
| NAV (Telephone Navigation) | Active comparator | Behavioral: NAV (Telephone Navigation)This group will receive telephone-based case navigation. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Score of 3 on KSADS screen for current psychosis or elevated mood
- Moderate to severe intellectual disability, and/or autism based on clinical chart.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAFE InterventionManualized individual youth and family psychotherapeutic intervention. Weekly individual and family sessions with a therapist for 6 weeks. Participants will continue to receive usual care. | Behavioural | SAFE Intervention |
| 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. | Behavioural | NAV (Telephone Navigation) |
Primary outcome
Number of Suicide Risk Events (SREs) throughout 6 months of study engagement
Time frame: Baseline, 6 weeks, 24 weeks
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).
10 secondary outcomes
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, 6 weeks, 24 weeks
Suicidal Ideation Questionnaire-Jr (SIQ-Jr)
Time frame: Baseline, 6 weeks, 24 weeks
Schedule for Affective Disorders and Schizophrenia Depression Rating Scale (KSADS-DEPc)
Time frame: Baseline, 6 weeks, 24 weeks
Screen for Child Anxiety Related Disorders (SCARED)
Time frame: Baseline, 6 weeks, 24 weeks
Centre for Epidemiological Studies Depression Scale for Children (CES-DC)
Time frame: Baseline, 6 weeks, 24 weeks
Life Problems Inventory (LPI)
Time frame: Baseline, 6 weeks, 24 weeks
Columbia Impairment Scale (CIS)
Time frame: Baseline, 6 weeks, 24 weeks
Conflict Behaviour Questionnaire (CBQ)
Time frame: Baseline, 6 weeks, 24 weeks
Cost-Effectiveness Ratio
Time frame: Baseline, 6 weeks, 24 weeks
Treatment Fidelity (Adherence and Competence) to the SAFE Intervention
Time frame: Baseline, 6 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAFE Intervention and NAV (Telephone Navigation) in people with Suicide and Suicide Prevention, run by The Hospital for Sick Children at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Suicide Risk Events (SREs) throughout 6 months of study engagement (time frame: Baseline, 6 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.