Focused Suicide Prevention Strategy for Youth

Study Overview
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Brief Summary
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This study evaluates whether a Family-centered suicide prevention strategy, when added to usual care (F-SPS + UC), is more effective than enhanced usual care (EUC) in reducing suicide-related behaviors in 128 youth at high-risk of suicide. Half of the participants will be randomized to receive F-SPS + UC and half will receive EUC.

Detailed Description
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This is a RCT of a patient- and family-centered suicide prevention intervention added to usual care (F-SPS + UC) for adolescents aged 12 to 18 years who present to the Emergency Department (ED) with suicidal ideation or suicide risk behaviours. The investigators will determine whether the F-SPS + UC intervention is more effective than enhanced usual care (EUC) in reducing suicide-related behaviors in 128 youth at high-risk of suicide. F-SPS 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. Enhanced usual care consists of 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.

Official Title
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A Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Randomized Controlled Trial

Conditions
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Suicide, Suicide, Attempted, Suicidal Ideation

Intervention / Treatment
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* Behavioral: F-SPS+UC
* Behavioral: EUC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 12 to18 years Youth presenting in the Emergency Department with acute suicidal ideation or suicide risk behaviour SIQ-Jr score ≥ 31 Parent or caregiver able to communicate in English, or is willing to communicate using a hospital-organized translator, and willing to participate in study Living in the greater Toronto area and access to a telephone. Exclusion Criteria: Active psychosis or hypomania/mania Moderate to severe intellectual disability, autism.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F-SPS Intervention<br>This group will receive the F-SPS intervention. | Behavioral: F-SPS+UC<br>* Manualized individual and family program. Weekly individual and family sessions with a therapist for 6 weeks. Participants will continue to receive usual care.<br>* Other names: F-SPS + UC;|
| Active Comparator: Enhanced Usual Care (EUC)<br>This group will receive Enhanced Usual Care (EUC) | Behavioral: EUC<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr | a 15-item measure self-report of suicide ideation (e.g., thoughts about death and dying) completed by the patient. Items are scored from 0 to 6, yielding a score from 0 to 90. Higher scores indicate more severe suicidal ideation. | Screening, 6 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in suicide related behavior as measured by the Suicide Behavior Questionnaire - Revised | A 4-item self-report questionnaire that measures suicide behavior, and yields a total score of 3 - 18. Higher scores indicate more severe suicidal behavior. | Screening, 6 weeks, 24 weeks | 
| Changes in emotional regulation using the Life Problems Inventory | A 60-item self-report scale that measures emotional regulation on a 5 point Likert scale from 1 to 5. Higher scores indicate more impaired emotional regulation. The measure has four subscales: Confusion about Self, Impulsivity, Emotion Dysregulation, and Interpersonal Chaos. Each subscale has a score from 15 to 75 where a higher score indicates more severity. | Baseline, 6 weeks, 24 weeks | 
| Change in family conflict as measured by the Conflict Behavior Questionnaire | A 20-item scale that examines the parent-child relationship using true/false ratings, yielding a total score of 0 to 20. Higher scores This measure is completed by both the youth and the parent(s) or caregiver. Higher scores indicate more severe family conflict. | Baseline, 6 weeks, 24 weeks | 
| Changes in global impairment as measured by the Columbia Impairment Scale | A 13-item scale designed to measure functioning on a 5 point Likert scale from 0 to 4, yielding a total score of 0 to 52. This measure is completed by both the youth and the parent(s) or caregiver. Higher scores indicate more severe impairment. | Baseline, 6 weeks, 24 weeks | 
| Changes in affect regulation as measured by the Children's Affective Lability Scale | A 20-item parent-report instrument that measures difficulties with emotion regulation on 5 point Likert scale from 0 to 4, yielding a score from 0 to 80. Higher scores indicate more severe affective lability. | Baseline, 6 weeks, 24 weeks | 
| Health Care Utilization Survey | A parent-report qualitative interview of a youth's use of available health care services, medication, and the costs associated with those services. | Baseline, 24 weeks | 
| Usual Care Tracking Survey | A parent-report qualitative interview of a youth's use of available health care services over a 1 week period of time. | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 |