Focused Suicide Prevention Strategy for Youth

NCT03488602 | Unknown

• 1 other identifier: 1000056892
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide; Suicide, Attempted; Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in suicide related behavior as measured by the Suicide Behavior Questionnaire - Revised

  Screening, 6 weeks, 24 weeks

• Changes in emotional regulation using the Life Problems Inventory

  Baseline, 6 weeks, 24 weeks

• Change in family conflict as measured by the Conflict Behavior Questionnaire

  Baseline, 6 weeks, 24 weeks

• Changes in global impairment as measured by the Columbia Impairment Scale

  Baseline, 6 weeks, 24 weeks

• Changes in affect regulation as measured by the Children's Affective Lability Scale

  Baseline, 6 weeks, 24 weeks

Study Arms (2)

F-SPS Intervention

EXPERIMENTAL

This group will receive the F-SPS intervention.

Behavioral: F-SPS+UC

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

This group will receive Enhanced Usual Care (EUC)

Behavioral: EUC

Interventions

F-SPS+UC BEHAVIORAL

Manualized individual and family program. Weekly individual and family sessions with a therapist for 6 weeks. Participants will continue to receive usual care.

Also known as: F-SPS + UC

F-SPS Intervention

EUC 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.

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Active psychosis or hypomania/mania
• Moderate to severe intellectual disability, autism.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• The Cundill Centre for Child and Youth Depression: collaborator
• SickKids Foundation: collaborator

Study Sites (1)

Matthew Tracey

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Related Publications (3)

• 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.

  PMID: 33884617 DERIVED

• 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.

  PMID: 32928140 DERIVED

• 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.

  PMID: 31937274 DERIVED

MeSH Terms

Conditions

Suicide; Suicide, Attempted; Suicidal Ideation

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Daphne J Korczak, MD, MSc

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Tracey, MA

CONTACT

4165358501; matthew.tracey@sickkids.ca

Reva Schachter, MSc

CONTACT

4165358501; reva.schachter@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research staff responsible for measuring outcomes will be blinded to participants' randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: April 5, 2018
• Study Start: March 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 5, 2018

Record last verified: 2018-03

Locations

CA (1)