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临床试验/NCT02923492
NCT02923492已完成不适用

Translation of an Intervention for Violence Among Adolescents in Emergency Departments

University of Michigan4 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2017年2月22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
185
试验地点
4
主要终点
Peer violence behaviors

研究概览

简要总结

The translation study aims to refine and package intervention and training materials essential to translating an efficacious Emergency Department (ED) based Brief Intervention (BI) for violence (SafERteens) for two delivery methods: by ED staff on site or by therapist remotely. The study will take place in two phases. During the Effectiveness phase, we will determine the effectiveness of the interventions [on-site therapist delivered BI + text messages (n=133); remote therapy delivered BI + text messages (n=133)], as compared to a usual care control (brochure; n=133), on violence outcomes at 3 months. Note that tailored text messages will be delivered daily for the first month post-discharge, and three times per week in the second month post-discharge to the BI groups. During the Implementation phase, components of the RE-AIM model will be assessed over a 4-month period.

详细描述

Participants who screen positive for the study during the effectiveness phase, will be randomized to either the therapy or control at a rate of 2:1. Whether the participant receives the on-site therapist or the remote therapist will depend on day of week or shift. Over the course of the study, the proportion of shifts covered by on-site verses remote therapists will be balanced for seasonality and time of day (evening vs. day time).

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 (Outcomes Assessor)

入排标准

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

入选标准

  • youth (ages 14-18) presenting to the Hurley Medical Center (HMC) ED who are medically stable. Patients classified by medical staff as having unstable vital signs or "Level 1" trauma (e.g., unconscious, in need of immediate lifesaving procedures such as surgery), will be approached during their inpatient stay after stabilization (4% based on prior work);
  • access to a parent or guardian for consent among adolescents ages 14-17 (over 90% based on our prior work).
  • Positive past 3 month violence screen criteria: Youth will be eligible for the study if they endorse on self-report computer survey past three month violence perpetration

排除标准

  • youth who do not understand English
  • youth deemed unable to provide informed assent/consent by ED or research staff
  • prisoners at time of ED presentation.
  • youth who present to the ED as victims of sexual abuse or child abuse

研究组 & 干预措施

In-person Therapy by ED Staff

Experimental

Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered by ED staff in-person.

干预措施: SafERteens (Behavioral)

Remote Therapy by Research Staff

Experimental

Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered remotely (over video) by research staff.

干预措施: SafERteens (Behavioral)

Comparison Group

No Intervention

This group will not receive an intervention, but did receive an informational pamphlet of resources in the area (enhanced usual care).

结局指标

主要结局

Peer violence behaviors

时间窗: Change from baseline to 3 months

as assessed with the modified Conflict Tactic Scale

Violence Consequences

时间窗: Change from baseline to 3 months

as assessment with a scale developed in the original SafERteens study

次要结局

  • Attitude towards viiolence(Change from baseline to 3 months)
  • Self-Efficacy for non-violence(Change from baseline to 3 months)

研究者

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

Maureen A Walton

Associate Professor of Psychiatry

University of Michigan

研究点 (4)

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