跳至主要内容
临床试验/NCT04089254
NCT04089254招募中不适用

A Multi-Site Study to Compare the Outcomes of Psychiatric Treatment of Suicidal Adolescents in Different Treatment Settings

Children's Hospital Medical Center, Cincinnati8 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
8
主要终点
Number of suicide events after treatment.

研究概览

简要总结

Quasi-Randomized trial to compare inpatient care versus outpatient crisis intervention clinic. This study plans to enroll up to 1,000 participants across 4 sites in a 5 years period.

详细描述

To address the unmet need of optimizing the treatment and management for adolescent suicidality, the investigators propose to evaluate if Outpatient Crisis Intervention Clinic (OCIC) leads to better treatment outcomes than inpatient treatment. To achieve this goal, the investigators propose a multi- site study to evaluate if OCIC, compared with inpatient care, can lead to a lower risk of a suicidal event (primary outcome) as well as higher treatment satisfaction (TS) and satisfaction with life (SL) (secondary outcomes) of both the legal guardians/parents and patients. Furthermore, the investigators will assess which clinical and socioeconomic factors at baseline may affect the treatment outcomes. With the results from the proposed study, the investigators will be able to reduce the family and clinician decisional uncertainty about the best treatment setting for suicidal adolescents in the target population. The results will significantly help patients, families, and clinicians with this decision-making process and improve outcomes for suicidal adolescents. The study has been designed to accomplish the following Specific Aims (SA):

SA1: Measure the differences between OCIC and inpatient treatment in the time to first recurrence of a suicidal event (a suicide attempt, interrupted attempt, hospitalization because of suicidal risk, an emergency/urgent evaluation because of suicidal risk, and a death by suicide) and the number of suicidal events over 30 days, 90 days and 180 days for suicidal adolescents after their baseline Emergency Department (ED) visits.

Hypothesis (H) 1.1: Assignment with randomization to OCIC from the ED will lead to a longer time to the first recurrence of a suicidal event compared to inpatient treatment after 30 days, 90 days and 180 days from the baseline ED visit for suicidality. H1.2 Assignment with randomization to OCIC will lead to a lower number suicidal events over 30 days, 90 days and 180 days when compared to inpatient treatment. H1.3 Heterogeneity of Treatment Effects [HTE]: The investigators will examine to what degree the following specific clinical features and sociodemographic features differ for patients who respond to OCIC or inpatient psychiatry treatment. Response is defined by a delay in first recurrence of a suicidal event and a lower number of suicidal events over 30 days, 90 days and 180 days. Clinical features: 1) Severity of suicidal ideation at baseline and over 180 days; 2) number of suicidal events at baseline only; 3) Substance use at baseline and over 180 days. Sociodemographic features at baseline: 1) Age 2) Gender 3) Gender Identity 4) Type of Insurance (public insurance/no insurance/private) 5) Ethnicity (Hispanic/Non); 6) Race (African-American (AA) versus non-African American); 7) Living with one biological parent, two biological parents, a stepparent, a relative, or other SA2: Assess the treatment satisfaction (TS) and satisfaction with life (SL) across OCIC and inpatient treatment.

H2.1: Overall, patients and legal guardians/parents in the OCIC group will have higher TS (at the completion of treatment in OCIC or inpatient psychiatry) and better SL than the inpatient treatment group over30 days, 90 and 180 days.

SA3: As an exploratory aim, assess the demographics and potential barriers to treatment for a third comparator of the "no show" group who were randomized to OCIC or inpatient treatment but never showed up or left the inpatient unit against medical advice (AMA).

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
None

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

  • Adolescents that are 12 through 17 years old (including 17 year olds who will turn 18 years old during the course of the study).
  • Are brought to the Emergency Department (ED) due to suicidal thoughts or behaviors
  • Require a higher level of care (OCIC or Inpatient) indicated by clinician determination and a CHRT-SR score of 15 to
  • The presence of a legal guardian
  • Capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

排除标准

  • Adolescents with suicidal thoughts that place themselves at a serious imminent risk of suicide based on clinical judgment.
  • Adolescents who require 24 hour/day supervision but no adult can provide 24 hour/day supervision outside of the hospital
  • Adolescents without the ability to read and answer survey questions
  • Adolescents that are non-English speaking due to the scales and surveys that are used for this study only being available in English.

结局指标

主要结局

Number of suicide events after treatment.

时间窗: 180 days

Measure the difference between OCIC and inpatient treatment in the number of suicidal events (a suicide attempt, interrupted attempt, hospitalization because of suicidal risk, an emergency/urgent evaluation because of suicidal risk, and a death by suicide) over 180 days for suicidal adolescents after their baseline ED visit.

Time to first recurrence of a suicide event

时间窗: 180 days

Measure the differences between OCIC and inpatient treatment in the time to first recurrence of a suicidal event (a suicide attempt, interrupted attempt, hospitalization because of suicidal risk, an emergency/urgent evaluation because of suicidal risk, and a death by suicide).

次要结局

  • Treatment Satisfaction as assessed using the Client Satisfaction Questionnaire-Adapted (CSQ).(180 days)
  • Demographic factors as assessed using the START demographics form.(180 days)
  • Quality of Life Satisfaction as assessed using the PROMIS® (Patient-Reported Outcomes Measurement Information System) Item Bank v1.0 - General Life Satisfaction - Short Form 5a(180 days)
  • Quality of Life Satisfaction as assessed using the PROMIS Pediatric Item Bank v1.0 - Life Satisfaction - Short Form 4a(180 days)
  • Quality of Life Satisfaction as assessed using PROMIS Parent Proxy Item Bank v1.0 - Life Satisfaction - Short Form 8a(180 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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