Focused Suicide Prevention Strategy for Youth

Not Applicable

• Conditions: Suicidal Ideation; Suicide; Suicide, Attempted
• Interventions: Behavioral: F-SPS+UC; Behavioral: EUC

• Registration Number: NCT03488602
• Lead Sponsor: The Hospital for Sick Children

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 Timeline

• Study First Submitted: 2018-02-08
• Status Verified: 2018-03
• Study Start: 2018-03-01
• Study First Submitted QC: 2018-03-28
• Last Update Submitted: 2018-03-28
• Study First Posted: 2018-04-05
• Last Update Posted: 2018-04-05
• Primary Completion: 2020-02
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
F-SPS Intervention	F-SPS+UC	This group will receive the F-SPS intervention.
Enhanced Usual Care (EUC)	EUC	This group will receive Enhanced Usual Care (EUC)

Primary Outcome Measures

Name	Time	Method
Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr	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 Outcome Measures

Name	Time	Method
Usual Care Tracking Survey	Week 1, Week 2, Week 3, Week 4, Week 5, Week 6	A parent-report qualitative interview of a youth's use of available health care services over a 1 week period of time.
Changes in affect regulation as measured by the Children's Affective Lability Scale	Baseline, 6 weeks, 24 weeks	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.
Change in suicide related behavior as measured by the Suicide Behavior Questionnaire - Revised	Screening, 6 weeks, 24 weeks	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.
Changes in global impairment as measured by the Columbia Impairment Scale	Baseline, 6 weeks, 24 weeks	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.
Health Care Utilization Survey	Baseline, 24 weeks	A parent-report qualitative interview of a youth's use of available health care services, medication, and the costs associated with those services.
Changes in emotional regulation using the Life Problems Inventory	Baseline, 6 weeks, 24 weeks	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.
Change in family conflict as measured by the Conflict Behavior Questionnaire	Baseline, 6 weeks, 24 weeks	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.

Trial Locations

Locations (1)

Matthew Tracey; 🇨🇦 Toronto, Ontario, Canada