跳至主要内容
临床试验/NCT02782728
NCT02782728已完成不适用

Trauma-informed Personalized Scripts (TIPS) to Address Relationship Abuse and Reproductive Coercion in Family Planning Clinics

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年6月最近更新:
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
240
试验地点
2
主要终点
Quality of intervention delivery by provider

研究概览

简要总结

This pilot study will evaluate a computer-based intervention titled "Trauma-informed Personalized Scripts" (TIPS). The goal of this intervention is to improve patient-provider communication about sensitive topics such as intimate partner violence (IPV) and reproductive coercion (RC). The main aim of this study is to pilot test TIPS in family planning clinics using a randomized study design to compare the basic version of TIPS (a computer-based assessment with provider scripts only) to an enhanced TIPS containing a tailored brief intervention for patients along with provider scripts. The investigators plan to recruit 240 female patients ages 16-29 for this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 29 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • age 16-29
  • English speaking
  • Plans to stay in the area for next 6 months

排除标准

  • Female clients not of the specified age range.
  • Clients who are intoxicated or otherwise not able to provide their own consent will not be eligible to participate.
  • Clients who are not able to read English will also be excluded from this pilot study as the survey questions presented via the tablet computer have not been validated yet in any other language.

研究组 & 干预措施

TIPS-Basic

Active Comparator

Providers receive tailored scripts based on the patient's responses to the questions administered via tablet.

干预措施: TIPS-Basic (Behavioral)

TIPS-Plus

Experimental

Patients receive tailored messages in addition to the scripts given to providers.

干预措施: TIPS-Plus (Behavioral)

结局指标

主要结局

Quality of intervention delivery by provider

时间窗: Immediately following clinic visit

Assessment of delivery of brief intervention previously tested and found to be helpful in family planning clinic settings (Addressing Reproductive Coercion in Health Settings (ARCHES), NCT01459458). Summary score based on patient responses on an after-visit exit survey inquiring about what elements of the intervention the provider discussed during clinic visit

次要结局

  • Difference in pregnancy risk(baseline to 4 months)
  • Change in self-efficacy to enact harm reduction behaviors (mean score)(Baseline to 4 months)
  • Enacting harm reduction behaviors (summary score)(4 months)
  • Change in knowledge of sexual and partner violence related services from baseline to follow up(Baseline to 4 months)
  • Any use of sexual and partner violence related services(4 months)
  • Change in violence victimization from baseline to follow up(Baseline to 4 months)

研究者

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

Elizabeth Miller

Chief of Adolescent Medicine, Professor of Pediatrics

University of Pittsburgh

研究点 (2)

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