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Clinical Trials/NCT03488602
NCT03488602UnknownNot Applicable

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

The Hospital for Sick Children1 site in 1 country128 target enrollmentStarted: March 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
128
Locations
1
Primary Endpoint
Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

The research staff responsible for measuring outcomes will be blinded to participants' randomization.

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

F-SPS Intervention

Experimental

This group will receive the F-SPS intervention.

Intervention: F-SPS+UC (Behavioral)

Enhanced Usual Care (EUC)

Active Comparator

This group will receive Enhanced Usual Care (EUC)

Intervention: EUC (Behavioral)

Outcomes

Primary Outcomes

Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr

Time Frame: Screening, 6 weeks, 24 weeks

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.

Secondary Outcomes

  • Changes in affect regulation as measured by the Children's Affective Lability Scale(Baseline, 6 weeks, 24 weeks)
  • Usual Care Tracking Survey(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
  • Change in suicide related behavior as measured by the Suicide Behavior Questionnaire - Revised(Screening, 6 weeks, 24 weeks)
  • Changes in global impairment as measured by the Columbia Impairment Scale(Baseline, 6 weeks, 24 weeks)
  • Health Care Utilization Survey(Baseline, 24 weeks)
  • Changes in emotional regulation using the Life Problems Inventory(Baseline, 6 weeks, 24 weeks)
  • Change in family conflict as measured by the Conflict Behavior Questionnaire(Baseline, 6 weeks, 24 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daphne Korczak

Psychiatrist

The Hospital for Sick Children

Study Sites (1)

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