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临床试验/NCT06660199
NCT06660199招募中不适用

Effectiveness of Text-based Support for Parents of Suicidal Adolescents Following Emergency Department Visits

University of Michigan2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
420
试验地点
2
主要终点
Aim 1 (primary aim): likelihood of suicidal behavior (actual, interrupted, or aborted attempts)

研究概览

简要总结

The goal of this study is to determine the effectiveness of an adaptive text-based intervention for parents of adolescents seeking emergency department services for suicide risk concerns.

详细描述

Participants will be 420 adolescents (ages 13-17) seen in ED with recent suicidal ideation and/or attempt and their parents recruited from two health system EDs in the Midwest.

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
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adolescent (13-17 years old) who present to Emergency Department (ED) due to (1) last-week suicidal ideation and/or (2) last-month suicide attempt, and their caregiver.

排除标准

  • •Adolescents who are:
  • •medically unstable
  • •presenting with severe cognitive impairment, altered mental status, severe aggression/agitation
  • •presenting without a legal guardian
  • •whose parent does not own a cell phone

研究组 & 干预措施

Standard ED care

No Intervention

Standard ED care with a text-based intervention

Experimental

This arm incorporates adolescent-centered (A-C) and parent-centered (P-C) texting components

Parents in the intervention arm will receive up to 3 text messages per day over six weeks after ED discharge: daily A-C text and up to two P-C messages. The P-C component includes an embedded micro-randomized trial (MRT), and parents will be randomized twice each day over the six-week intervention to either receive or not receive a P-C message.

干预措施: Text-based intervention (Behavioral)

结局指标

主要结局

Aim 1 (primary aim): likelihood of suicidal behavior (actual, interrupted, or aborted attempts)

时间窗: 12-week follow-up

Suicidal behavior encompasses actual, interrupted, and aborted suicide attempts. Measured with the behavioral subscale of the Columbia-Suicide Severity Rating Scale (C-SSRS),and supplemented with available medical chart data.

Aim 2 (secondary aim) severity of parental stress

时间窗: Up to 6 weeks

Measured with twice daily surveys over the 6-week intervention

次要结局

  • Aim 1 (primary aim): -time- to- suicidal behavior (actual, interrupted, or aborted suicide attempts(24-week follow-up)
  • Aim 1 (primary aim): time- to- return ED visit(24-week follow-up.)
  • Aim 2 (secondary aim): parental negative affect(Up to 6 weeks)
  • Aim 2 (secondary aim) parental positive affect(Up to 6 weeks)

研究者

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

Ewa Czyz

Associate Professor of Psychiatry

University of Michigan

研究点 (2)

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