Focused Suicide Prevention Strategy for Youth (FSPS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Suicidal Ideation; Suicide, Attempted; Suicide
• Intervention / Treatment: Behavioral: F-SPS+UC; Behavioral: 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 Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • Matthew Tracey
      • Sub-Investigator: Myla Moretti, PhD
      • Contact: Matthew Tracey, MA; Phone Number: 201575 4165358501; Email: matthew.tracey@sickkids.ca
      • Contact: Reva Schachter, MSc; Phone Number: 201469 4165358501; Email: reva.schachter@sickkids.ca
      • Principal Investigator: Daphne J Korczak, MD, Msc
      • Principal Investigator: Yaron Finkelstein, MD
      • Sub-Investigator: Melanie Barwick, PhD
      • Sub-Investigator: Peter Szatmari, MD
      • Sub-Investigator: Kristin Cleverly, PhD
      • Sub-Investigator: Gloria Chaim, MSW
      • Sub-Investigator: Joanna Henderson, PhD
      • Sub-Investigator: Suneeta Monga, MD
      • Sub-Investigator: David Juurlink, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: SickKids Foundation; The Cundill Centre for Child and Youth Depression
• Investigators: Principal Investigator: Daphne J Korczak, MD, MSc, The Hospital for Sick Children

Publications and helpful links

General Publications

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
• Tracey M, Finkelstein Y, Schachter R, Cleverley K, Monga S, Barwick M, Szatmari P, Moretti ME, Willan A, Henderson J, Korczak DJ. Recruitment of adolescents with suicidal ideation in the emergency department: lessons from a randomized controlled pilot trial of a youth suicide prevention intervention. BMC Med Res Methodol. 2020 Sep 14;20(1):231. doi: 10.1186/s12874-020-01117-5.
• Korczak DJ, Finkelstein Y, Barwick M, Chaim G, Cleverley K, Henderson J, Monga S, Moretti ME, Willan A, Szatmari P. A suicide prevention strategy for youth presenting to the emergency department with suicide related behaviour: protocol for a randomized controlled trial. BMC Psychiatry. 2020 Jan 14;20(1):20. doi: 10.1186/s12888-019-2422-y.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: 1000056892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No