跳至主要内容
临床试验/NCT07092345
NCT07092345招募中不适用

An Adaptive Intervention to Increase Engagement to Community-based Care After an ED Admission: For Youth at Risk for Suicide and Self-injurious Behavior

Rhode Island Hospital1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2025年3月17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
186
试验地点
1
主要终点
Intervention Feasibility

研究概览

简要总结

The goal of this study is to develop a feasible brief, family-based adaptive intervention, via SMART design, for youth with suicidal and non-suicidal self-injurious behavior (SSIB) to increase community-based mental health (MH) care attendance and reduce SSIB risk post emergency department (ED) admission. The intervention will focus to increase understanding on youth MH literacy, MH communication, and MH engagement. Integrating an adaptive intervention via a SMART design in the ED could address subsequent barriers to youth obtaining appropriate level of community-based MH care and therefore reduce ED readmissions.

详细描述

This adaptive intervention allows for two stages of randomization to address treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only condition or the psychosocial with digital health communication via text messages condition. If after two weeks, youth are identified as non-response, then dyads will be re-randomized to 2nd-stage intervention(s) that will include the use of a family navigation model.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Youth 8 to 17 years
  • •Youth presenting to the ED with suicide and self-injurious behavior
  • •Youth living at home with at least one legal guardian/caregiver

排除标准

  • •Youth presenting to the ED with psychosis, sexual assault, child abuse
  • •Youth in police custody,
  • •Youth with an active investigation with the department of child and youth services (DCYF)
  • •Youth unable to assent due to severity of illness or developmental disabilities,
  • •Youth who cannot communicate in English or Spanish,
  • •Youth without a caregiver/legal guardian who can provide consent

研究组 & 干预措施

Psychosocial

Experimental

Digitally delivered psychosocial

干预措施: adaptive intervention (Behavioral)

Psychosocial with text messages

Experimental

Digitally delivered psychosocial with text messages

干预措施: adaptive intervention (Behavioral)

Psychosocial with text messages and family navigator

Experimental

Digitally delivered psychosocial with text messages and human family navigator

干预措施: adaptive intervention (Behavioral)

结局指标

主要结局

Intervention Feasibility

时间窗: 3-month & 6-month follow-up assessments

Recruitment rate (% of ppl who agree to be in the study), Study completion (% of ppl who complete entire study)

Child and Adolescent Service Assessment (CASA)

时间窗: 3-month and 6-month follow-up assessments

Youth Attendance to Community-based Mental Health Care. CASA question and caregiver report of youth attendance in behavioral health care/community-based mental health services (yes or no) after discharge from emergency department admission.

Intervention Acceptability

时间窗: 3-month and 6-month follow-up assessments

Client Satisfaction Questionnaire. An 8-item questionnaire that provides (positive \& negative) feedback from user opinion. Higher scores = greater satisfaction with intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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