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临床试验/NCT05900700
NCT05900700已完成不适用

An Open-Label Study of the Feasibility and Usability of a Digital Psychoeducational Social Network Intervention for Suicidal Adolescents

University of Michigan1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年11月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
System Usability Scale (SUS) Score - Youth Participants

研究概览

简要总结

The Electronic Youth-Nominated Support Team (eYST), is experimental. The purpose of this study is to get feedback from users about eYST. Another purpose of this study is to learn how well eYST helps youth.

详细描述

Assessment data from multiple stakeholders (i.e., youth, parents, and support adults) will be collected at baseline, 4 weeks, 8 weeks, and 12 weeks via self-report and semi-structured interviews.

A request to extend the record's NIH results reporting deadline to November 1, 2025 was submitted in a timely manner prior to October-November 2025 government shutdown. This request was approved retroactively once the shutdown ended on November 12. During the shutdown, the record was locked and could not be edited by the Responsible Party. Results were submitted as soon as possible upon the unlocking of the record.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Inpatient psychiatric patients who have attempted suicide or have documented Suicide ideation (SI) and a plan to harm themselves at admission.
  • Understand written and spoken English.
  • Own a smartphone or mobile phone.
  • Willing and able to complete enrollment procedures.
  • Parent or guardian and youth able to understand the nature of the study and provide written informed consent and assent for youth
  • Patients who are able to provide at least one verifiable contact for emergency or tracking purposes.

排除标准

  • Patients with active psychosis.
  • Patients experiencing substance withdrawal.
  • Currently enrolled in other treatment studies for the symptoms and behaviors targeted.
  • Patient unwilling or unable to wear a mask during in person study procedures, if mandated due to current COVID/health safety guidelines.
  • Patients who in the judgment of the investigator would have an unfavorable risk or benefit profile with respect to eYST.
  • Any other psychiatric or medical condition or custody arrangement that in the investigators' opinion would preclude informed consent or assent or participation in the trial.

研究组 & 干预措施

eYST website

Experimental

干预措施: eYST website (Behavioral)

结局指标

主要结局

System Usability Scale (SUS) Score - Youth Participants

时间窗: At 4 Weeks

10-item measure. Scores ranged from 0 to 100. The researchers calculated the mean score. A mean score of 68 was the minimal indicator of usability. Results reflect data from Youth Participants.

System Usability Scale (SUS) Score - Adult Caregiver Participants

时间窗: At 4 Weeks

10-item measure. Scores ranged from 0 to 100. The researchers calculated the mean score. A mean score of 68 was the minimal indicator of usability. Results reflect data from Adult Caregiver Participants.

System Usability Scale (SUS) Score - Adult Support Participants

时间窗: At 8 Weeks

10-item measure. Scores ranged from 0 to 100. The researchers calculated the mean score. A mean score of 68 was the minimal indicator of usability. Results reflect data from Adult Support Participants.

Frequency of Use of App - Youth Participants

时间窗: Weeks 1, 4, 8, and 12

Website usage metrics were captured by counting the number of website log-ins by Youth (adolescent) Participants.

Frequency of Use of App - Adult Caregiver Participants

时间窗: Weeks 1, 4, 8, and 12

Website usage metrics were captured by counting the number of website log-ins by parents/caregivers.

Frequency of Use of App - Adult Support Participants

时间窗: Week 1, 4, 8, 12

Website usage metrics were captured by counting the number of website log-ins by supporting adults.

Duration of Use of App - Youth Participants

时间窗: Weeks 1, 4, 8, and 12

Website usage metrics were captured by measuring the duration of website use by adolescents.

Duration of Use of App - Adult Caregiver Participants

时间窗: Weeks 1, 4, 8, and 12

Website usage metrics were captured by measuring the duration of website use by parents/caregivers.

Duration of Use of App - Adult Support Participants

时间窗: Weeks 1, 4, 8, and 12

Website usage metrics were captured by measuring the duration of website use by by support adults.

次要结局

  • Feasibility of Intervention Measure (FIM) - Youth Participants(At 4 Weeks)
  • Feasibility of Intervention Measure (FIM) - Adult Caregiver Participants(At 4 Weeks)
  • Feasibility of Intervention Measure (FIM) - Adult Support Participants(At 8 Weeks)
  • Acceptability of Intervention Measure (AIM) - Youth Participants(At 4 Weeks)
  • Acceptability of Intervention Measure (AIM) - Adult Caregiver Participants(At 4 Weeks)
  • Acceptability of Intervention Measure (AIM) - Adult Support Participants(At 8 Weeks)
  • Intervention Appropriateness Measure (IAM) - Youth Participants(At 4 Weeks)
  • Intervention Appropriateness Measure (IAM) - Adult Caregiver Participants(At 4 Weeks)
  • Intervention Appropriateness Measure (IAM) - Adult Support Participants(At 8 Weeks)
  • Client Satisfaction Questionnaire (CSQ-I) - Youth Participants(At 4 Weeks)
  • Client Satisfaction Questionnaire (CSQ-I) - Adult Caregiver Participants(At 4 Weeks)
  • Client Satisfaction Questionnaire (CSQ-I) - Adult Support Participants(At 8 Weeks)

研究者

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

Alejandra Arango

Assistant Professor of Psychiatry

University of Michigan

研究点 (1)

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