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临床试验/NCT02578147
NCT02578147终止不适用

JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls

University of Miami1 个研究点 分布在 1 个国家目标入组 552 人开始时间: 2015年9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
终止
入组人数
552
试验地点
1
主要终点
Change in risky sexual behavior from baseline (pre-intervention)

研究概览

简要总结

The purpose of this study is to have girls play new computer games designed for middle school children and not yet available to the public. The investigator wants to know what girls think about these games. The investigator also wants to learn about the health behavior of 7th grade girls of Hispanic/Brazilian/Latino origin, and the investigators want to test the Mighty Girls program in Miami. Half of the girls in JUEGA will be given the Mighty Girls program and the investigators want to know if this program reduces behavior that puts girls at risk for having sex, drinking, and using drugs. The program tries to reduce this risk by helping girls learn skills to make wise choices, even when their friends have other ideas or want them to make more risky choices This goal is important because US statistics indicate that Hispanic teens are at risk for teen pregnancy and Miami has one of the highest HIV and AIDS rates in the United States. The investigator wants to find out whether the Mighty Girls program is as effective in Miami-Dade County Public Schools as it was when tested in one of Orlando's Orange County Public Schools.

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
11 Years 至 14 Years(Child)
性别
Female
接受健康志愿者
是

入选标准

  • •English Speaking
  • •enrolled in 7th grade at a participating school

排除标准

  • •developmental delay

研究组 & 干预措施

Mighty Girls

Experimental

Girls in this group complete 3 different activities after school: 6 classroom sessions, 4 DRAMA-RAMA game play sessions, and 4 short game experience surveys. Classroom sessions are 1 hour long, 3 days a week for 2 weeks. Topics include: goal setting, choices and their effects; defining what makes a behavior risky; learning how to not get talked into doing risky things by friends (e.g., going to a party at a house where parents are not home); and learning to be critical of TV shows and other media that make it seem like lots of teens are having sex. These sessions teach girls skills and strategies that help them score game points in DRAMA-RAMA. These are important skills and strategies that they can use in everyday life to make wise choices. Classroom sessions are designed to be fun.

干预措施: Mighty Girls (Behavioral)

Game Girls

Active Comparator

Girls in this group take part in activities that can be done from home or anywhere they have Wi-Fi access: 4 Science Valley game play sessions and 4 short game experience surveys. Science Valley is a web based game in which girls explore a virtual world and experiment with objects in this world using a computer, tablet or cell phone. Girls will play this game for about 20-30 minutes. There are no classroom sessions required to be able to play Science Valley. Science Valley is designed to be fun and to give girls a chance to build skills important to doing well in school: her problem solving and critical thinking skills. Girls will be given a link to use to access Science Valley on the internet. At the end of the game, they do a short game experience survey that asks questions about how easy, how hard, how fun etc. it was to play Science Valley. This survey will appear on the screen at the end of the Science Valley game play session.

干预措施: Game Girls (Behavioral)

结局指标

主要结局

Change in risky sexual behavior from baseline (pre-intervention)

时间窗: baseline, 3 months, 12 months, 24 months

Risky sexual behavior is defined as the change in the percentage of participants reporting yes for engaging in heavy petting and percentage reporting yes for engaging in vaginal intercourse on an electronic survey.

Change in sexual intentions from baseline (pre-intervention)

时间窗: baseline, 3 months, 12 months, 24 months

Sexual intentions are defined as the change in a score from 1 (definitely not) to 4 (definitely yes) to engage in sexual intercourse in the near future on an electronic survey.

次要结局

  • Change in sexual intentions from baseline (pre-intervention) as affected by the change in peer resistance self-efficacy(baseline, 3 months, 12 months, 24 months)
  • Change in risky sexual behavior from baseline (pre-intervention) as affected by the change in peer resistance self-efficacy(baseline, 3 months, 12 months, 24 months)
  • Change in risky sexual behavior from baseline (pre-intervention) as affected by implementation quality(baseline, 3 months, 12 months, 24 months)
  • Costs of implementation of the intervention(4 months)
  • Change in sexual intentions from baseline (pre-intervention) as affected by implementation quality(baseline, 3 months, 12 months, 24 months)

研究者

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

Anne E. Norris

Professor

University of Miami

研究点 (1)

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