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临床试验/NCT03410238
NCT03410238已完成不适用

Translation of an Evidenced-Based Violence Intervention for Adolescents in Primary Care

University of Michigan2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
2
主要终点
Change in Violent Behavior

研究概览

简要总结

The SafERteens Study demonstrated the efficacy of a brief intervention (BI) for violence on changing attitudes, self-efficacy, and reducing violent behaviors, peer victimization, and violence-related consequences among adolescents in the emergency department (ED). Using a RE-AIM framework to measure outcomes (Reach, Effectiveness, Adoption, Implementation, and Maintenance), a study was conducted to translate this BI for violence into clinical practice in the ED. A SafERteens Implementation Package was created, which is housed on a website (www.saferteens.org), and includes: 1) a self-administered screen via iPad; 2) training materials (e.g., standardized patient videos); 3) clinician tools to guide intervention delivery; and 4) a tailored text message booster program.

To increase reach and impact on reducing youth violence, this project will implement SafERteens into primary care. Primary care represents a logical dissemination channel for the SafERteens intervention because 95% of adolescents report having a usual place for primary health care, with 75% receiving medical care in the past six months. Violence interventions have yet to be systematically implemented in primary care settings despite the alarming prevalence of violent behaviors among adolescents.

详细描述

This pilot study will customize the SafERteens intervention for the unique constraints of primary care settings and test implementation of the Saferteens brief intervention in primary care using the RE-AIM framework: reach (e.g., number of patients screened and given BI); effectiveness (e.g., change in violent behaviors, peer victimization, and violence-related consequences among intervention and control groups); adoption (e.g., number of providers trained, hours participated in training); implementation (e.g., participant ratings of intervention); and maintenance (e.g., ongoing screening and interventions during maintenance phase). Specifically, a control sample of youth ages 14-18 will be obtained, who will complete a baseline and 3-month follow-up survey, but who will not receive the intervention, and an intervention sample of youth ages 14-18 will be obtained, who will receive the Saferteens BI and will complete a baseline and 3-month follow-up survey. These data will provide a control sample for testing effectiveness of the Saferteens intervention package, versus the intervention sample.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • Adolescents (ages 14-18) presenting to primary care
  • Screen positive for past year violent behavior (physical aggression) toward a friend, stranger, acquaintance, or dating partner (e.g., "have you pushed, hit, slapped, punched, kicked, been in a serious physical fight, group fight, or beat someone up

排除标准

  • Adolescents who do not understand English
  • Adolescents deemed unable to provide informed assent/consent (e.g., mental incompetence)

结局指标

主要结局

Change in Violent Behavior

时间窗: 3 months post-baseline

Change in violent behavior is assessed using 10 validated items from the National Longitudinal Study of Adolescent Health and Conflict Tactics Scale and assess the frequency of moderate (e.g., pushed or shoved) and severe (e.g., hit or punched, used a knife/gun) aggression towards peers. A composite score will be computed by summing the midpoint of responses to facilitate assessing change between baseline and follow-up.

Change in Violence Consequences

时间窗: 3 months post-baseline

Change in violence consequences is assessed using a 7 item scale. This scale was developed for the original SafERteens study and inquires about possible consequences of fighting, like trouble at school and expressed concern about fighting by family members or friends. A composite score will be computed to facilitate measuring change between baseline and follow-up.

Change in Victimization by peers

时间窗: 3 months post-baseline

Change in victimization by peers is assessed using 2 validated items from the Conflict Tactics Scale which assess the frequency of moderate and severe peer victimization. A composite score will be computed by summing the midpoint of the items to facilitate measuring change between baseline and follow-up.

次要结局

未报告次要终点

研究者

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

Maureen A Walton

Professor

University of Michigan

研究点 (2)

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