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Focused Suicide Prevention Strategy for Youth (FSPS)

Primary Purpose

Suicide, Suicide, Attempted, Suicidal Ideation

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
F-SPS+UC
EUC
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Matthew TraceyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

F-SPS Intervention

Enhanced Usual Care (EUC)

Arm Description

This group will receive the F-SPS intervention.

This group will receive Enhanced Usual Care (EUC)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 8, 2018
Last Updated
March 28, 2018
Sponsor
The Hospital for Sick Children
Collaborators
The Cundill Centre for Child and Youth Depression, SickKids Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03488602
Brief Title
Focused Suicide Prevention Strategy for Youth
Acronym
FSPS
Official Title
A Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
The Cundill Centre for Child and Youth Depression, SickKids Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicide, Attempted, Suicidal Ideation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The research staff responsible for measuring outcomes will be blinded to participants' randomization.
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
F-SPS Intervention
Arm Type
Experimental
Arm Description
This group will receive the F-SPS intervention.
Arm Title
Enhanced Usual Care (EUC)
Arm Type
Active Comparator
Arm Description
This group will receive Enhanced Usual Care (EUC)
Intervention Type
Behavioral
Intervention Name(s)
F-SPS+UC
Other Intervention Name(s)
F-SPS + UC
Intervention Description
Manualized individual and family program. Weekly individual and family sessions with a therapist for 6 weeks. Participants will continue to receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
EUC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr
Description
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.
Time Frame
Screening, 6 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change in suicide related behavior as measured by the Suicide Behavior Questionnaire - Revised
Description
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.
Time Frame
Screening, 6 weeks, 24 weeks
Title
Changes in emotional regulation using the Life Problems Inventory
Description
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.
Time Frame
Baseline, 6 weeks, 24 weeks
Title
Change in family conflict as measured by the Conflict Behavior Questionnaire
Description
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.
Time Frame
Baseline, 6 weeks, 24 weeks
Title
Changes in global impairment as measured by the Columbia Impairment Scale
Description
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.
Time Frame
Baseline, 6 weeks, 24 weeks
Title
Changes in affect regulation as measured by the Children's Affective Lability Scale
Description
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.
Time Frame
Baseline, 6 weeks, 24 weeks
Title
Health Care Utilization Survey
Description
A parent-report qualitative interview of a youth's use of available health care services, medication, and the costs associated with those services.
Time Frame
Baseline, 24 weeks
Title
Usual Care Tracking Survey
Description
A parent-report qualitative interview of a youth's use of available health care services over a 1 week period of time.
Time Frame
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Tracey, MA
Phone
4165358501
Ext
201575
Email
matthew.tracey@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Reva Schachter, MSc
Phone
4165358501
Ext
201469
Email
reva.schachter@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daphne J Korczak, MD, MSc
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Matthew Tracey
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Tracey, MA
Phone
4165358501
Ext
201575
Email
matthew.tracey@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Reva Schachter, MSc
Phone
4165358501
Ext
201469
Email
reva.schachter@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Daphne J Korczak, MD, Msc
First Name & Middle Initial & Last Name & Degree
Yaron Finkelstein, MD
First Name & Middle Initial & Last Name & Degree
Melanie Barwick, PhD
First Name & Middle Initial & Last Name & Degree
Peter Szatmari, MD
First Name & Middle Initial & Last Name & Degree
Kristin Cleverly, PhD
First Name & Middle Initial & Last Name & Degree
Gloria Chaim, MSW
First Name & Middle Initial & Last Name & Degree
Joanna Henderson, PhD
First Name & Middle Initial & Last Name & Degree
Suneeta Monga, MD
First Name & Middle Initial & Last Name & Degree
David Juurlink, MD
First Name & Middle Initial & Last Name & Degree
Myla Moretti, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33884617
Citation
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.
Results Reference
derived
PubMed Identifier
32928140
Citation
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.
Results Reference
derived
PubMed Identifier
31937274
Citation
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.
Results Reference
derived

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Focused Suicide Prevention Strategy for Youth

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