Focused Suicide Prevention Strategy for Youth

Suicide Clinical Trial

— FSPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03488602
• Other study ID #: 1000056892
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2018
• Last updated: March 28, 2018
• Start date: March 1, 2018
• Est. completion date: July 2020

Study information

• Verified date: March 2018
• Source: The Hospital for Sick Children
• Contact: Matthew Tracey, MA
• Phone: 4165358501
• Email: matthew.tracey[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: July 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide, Attempted

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.
• 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.

Locations

Country	Name	City	State
Canada	Matthew Tracey	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	SickKids Foundation, The Cundill Centre for Child and Youth Depression

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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