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临床试验/NCT02610309
NCT02610309已完成不适用

Family-based Crisis Intervention With Suicidal Adolescents in the Emergency Department: A Randomized Clinical Trial

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
143
试验地点
2
主要终点
Disposition at discharge from the ED (psychiatric hospitalization or other)

研究概览

简要总结

The Family Based Crisis Intervention (FBCI) is an emergency psychiatry intervention designed to sufficiently stabilize suicidal adolescents within a single ED visit so that they may return home safely with their families. This study is a randomized clinical trial of FBCI v. TAU in an urban Emergency Department.

详细描述

In current practice, treatment as usual (TAU) for suicidal adolescents includes evaluation, with little or no intervention provided in the Emergency Department (ED), and disposition, usually to an inpatient psychiatry unit. The Family Based Crisis Intervention (FBCI) is an emergency psychiatry intervention designed to sufficiently stabilize suicidal adolescents within a single ED visit so that they may return home safely with their families. The intervention works intensively with both the adolescent and the family, so that the caregiver has the knowledge and skills to help the adolescent after discharge.

In this study, suicidal adolescents (ages 13-18) and their families presenting for psychiatric evaluation to a large pediatric ED were randomized to receive FBCI or treatment as usual (TAU). Patients and caregivers completed self-report measures of suicidality, family empowerment, and satisfaction with care provided at pre-test, post-test, and 3 follow up time-points over a one-month period. Clinicians contacted the adolescent and caregiver at these timepoints to administer the questionnaires and assure safety planning was being carried out.

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 (Participant)

入排标准

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

入选标准

  • adolescent presenting to the ED with suicidality
  • presence of a consenting parent or legal guardian with whom the adolescent resided.

排除标准

  • either adolescent or parent/guardian lacked fluency in English;
  • adolescent was not medically stable, including intoxication;
  • adolescent demonstrated cognitive limitations prohibiting completion of research instruments;
  • adolescent presented with active psychosis;
  • adolescent required physical or medication restraint in the ED.

结局指标

主要结局

Disposition at discharge from the ED (psychiatric hospitalization or other)

时间窗: one day, one week, and one month

The primary outcome measure is disposition (psychiatric hospitalization vs. less restrictive level of care) after receiving the FBCI intervention or TAU. Psychiatric hospitalization was reassessed at 1 day, 1 week and 1 month intervals after randomization.

次要结局

  • Family Empowerment Scale (FES)(one month)
  • Client Satisfaction Questionnaire (CSQ-8)(one day)

研究者

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

Elizabeth Wharff

Clinical Researcher

Boston Children's Hospital

研究点 (2)

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