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临床试验/NCT02993185
NCT02993185已完成不适用

An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy

Carnegie Mellon University1 个研究点 分布在 1 个国家目标入组 808 人开始时间: 2016年10月1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
808
试验地点
1
主要终点
Number of sexual partners for vaginal intercourse

研究概览

简要总结

The purpose of Making Healthy Decisions is to design and rigorously evaluate a new sexual health education program, "Your Move" (YM) against a nutrition control program, "Eat Smart" (ES). YM is intended to improve teen females' (ages 14-19) ability to make healthy sexual decisions with the ultimate goal of reducing unplanned pregnancies and STIs.

详细描述

Making Healthy Decisions includes two technology-based interventions designed to improve teen females' healthy decision making in relation to sexual relationships (YM) and nutrition (ES).

Health educators from Planned Parenthood are trained to implement both YM and ES at youth-serving community organizations in their geographic area across several U.S. states. In a multi-site randomized controlled trial, females ages 14-19 are recruited from their local community-based organization (CBO) into groups/cohorts of 8-12.

Each cohort is randomly assigned to participate in one of the two interventions prior to baseline data collection.

Participants attend seven 75-minute program sessions that include facilitator-led games, activities, and discussions as well as personal reflection time in which girls practiced healthy decision making individually on an electronic tablet.

Self-reported survey data related to attitudes, knowledge, and behavior around sex and nutrition are collected at baseline as well as 3 months after the intervention ends.

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
14 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Female (or identify as female); age 14-19

排除标准

  • •Male (or identify as male); female older than 19 or younger than 14

研究组 & 干预措施

Your Move

Experimental

Sex education intervention

干预措施: Your Move (Behavioral)

Eat Smart

Active Comparator

Nutrition education intervention

干预措施: Eat Smart (Behavioral)

结局指标

主要结局

Number of sexual partners for vaginal intercourse

时间窗: 3 months post intervention

Number of partners with whom had vaginal sex

Number of incidents of vaginal sex without using hormonal contraception, copper IUD, or condoms

时间窗: 3 months post intervention

Number of times reported having vaginal sex without hormonal contraception, copper IUD, condoms, or insertive condoms

Number of incidents of vaginal sex without condoms

时间窗: 3 months post intervention

Number of times reported having vaginal sex without using condoms or insertive condoms

次要结局

  • Perceived self efficacy to communicate about sexual boundaries and condom use(3 months post intervention)
  • Number of incidents of vaginal intercourse(3 months post intervention)
  • Condom errors or failure(3 months post intervention)
  • Number of incidents of vaginal, oral, or anal sex without using condoms(3 months post intervention)
  • Number of sexual partners for vaginal, oral, or anal intercourse(3 months post intervention)

研究者

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

Julie Downs

Associate Professor

Carnegie Mellon University

研究点 (1)

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