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临床试验/NCT03488602
NCT03488602Unknown不适用

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

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
128
试验地点
2
主要终点
Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

F-SPS Intervention

Experimental

This group will receive the F-SPS intervention.

干预措施: F-SPS+UC (Behavioral)

Enhanced Usual Care (EUC)

Active Comparator

This group will receive Enhanced Usual Care (EUC)

干预措施: EUC (Behavioral)

结局指标

主要结局

Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr

时间窗: 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.

次要结局

  • Changes in affect regulation as measured by the Children's Affective Lability Scale(Baseline, 6 weeks, 24 weeks)
  • Usual Care Tracking Survey(Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
  • Change in suicide related behavior as measured by the Suicide Behavior Questionnaire - Revised(Screening, 6 weeks, 24 weeks)
  • Changes in global impairment as measured by the Columbia Impairment Scale(Baseline, 6 weeks, 24 weeks)
  • Health Care Utilization Survey(Baseline, 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daphne Korczak

Psychiatrist

The Hospital for Sick Children

研究点 (2)

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