Clinical trial NCT03488602: Focused Suicide Prevention Strategy for Youth
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
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide
Suicide, Attempted
Suicidal Ideation
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: The Cundill Centre for Child and Youth Depression
name: SickKids Foundation
First posted: 2018-04-05
Enrollment: 128
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr
timeFrame: Screening, 6 weeks, 24 weeks
Secondary outcomes:
measure: Change in suicide related behavior as measured by the Suicide Behavior Questionnaire - Revised
timeFrame: Screening, 6 weeks, 24 weeks
measure: Changes in emotional regulation using the Life Problems Inventory
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Change in family conflict as measured by the Conflict Behavior Questionnaire
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Changes in global impairment as measured by the Columbia Impairment Scale
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Changes in affect regulation as measured by the Children's Affective Lability Scale
timeFrame: Baseline, 6 weeks, 24 weeks
measure: Health Care Utilization Survey
timeFrame: Baseline, 24 weeks
measure: Usual Care Tracking Survey
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Matthew Tracey
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Daphne J Korczak, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.