Focused Suicide Prevention Strategy for Youth (FSPS)

March 28, 2018 updated by: Daphne Korczak, The Hospital for Sick Children

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • Matthew Tracey
        • Sub-Investigator:
          • Myla Moretti, PhD
        • Contact:
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Screening, 6 weeks, 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in suicide related behavior as measured by the Suicide Behavior Questionnaire - Revised
Time Frame: 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.
Screening, 6 weeks, 24 weeks
Changes in emotional regulation using the Life Problems Inventory
Time Frame: 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.
Baseline, 6 weeks, 24 weeks
Change in family conflict as measured by the Conflict Behavior Questionnaire
Time Frame: 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.
Baseline, 6 weeks, 24 weeks
Changes in global impairment as measured by the Columbia Impairment Scale
Time Frame: 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.
Baseline, 6 weeks, 24 weeks
Changes in affect regulation as measured by the Children's Affective Lability Scale
Time Frame: 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.
Baseline, 6 weeks, 24 weeks
Health Care Utilization Survey
Time Frame: 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.
Baseline, 24 weeks
Usual Care Tracking Survey
Time Frame: 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.
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SickKids Foundation
The Cundill Centre for Child and Youth Depression

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daphne J Korczak, MD, MSc, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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