Focused Suicide Prevention Strategy for Youth

NCT ID: NCT03488602

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Suicide Suicide, Attempted Suicidal Ideation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The research staff responsible for measuring outcomes will be blinded to participants' randomization.

Study Groups

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F-SPS Intervention

This group will receive the F-SPS intervention.

Group Type EXPERIMENTAL

F-SPS+UC

Intervention Type BEHAVIORAL

Manualized individual and family program. Weekly individual and family sessions with a therapist for 6 weeks.

Participants will continue to receive usual care.

Enhanced Usual Care (EUC)

This group will receive Enhanced Usual Care (EUC)

Group Type ACTIVE_COMPARATOR

EUC

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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F-SPS + UC

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cundill Centre for Child and Youth Depression

UNKNOWN

Sponsor Role collaborator

SickKids Foundation

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Daphne Korczak

Psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daphne J Korczak, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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Matthew Tracey

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Matthew Tracey, MA

Role: CONTACT

4165358501 ext. 201575

Reva Schachter, MSc

Role: CONTACT

4165358501 ext. 201469

Facility Contacts

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Matthew Tracey, MA

Role: primary

4165358501 ext. 201575

Reva Schachter, MSc

Role: backup

4165358501 ext. 201469

References

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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.

Reference Type DERIVED
PMID: 33884617 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32928140 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31937274 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1000056892

Identifier Type: -

Identifier Source: org_study_id

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