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Trial record 42 of 1031 for:    Recruiting, Not yet recruiting, Available Studies | "Adolescent"

JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls

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ClinicalTrials.gov Identifier: NCT02578147
Recruitment Status : Recruiting
First Posted : October 16, 2015
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Anne E. Norris, University of Miami

Brief Summary:
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.

Condition or disease Intervention/treatment
Pregnancy in Adolescence Behavioral: Mighty Girls Behavioral: Game Girls

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls
Study Start Date : September 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Mighty Girls
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.
Behavioral: Mighty Girls
Active Comparator: Game Girls
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.
Behavioral: Game Girls



Primary Outcome Measures :
  1. A change in risky sexual behavior from baseline (pre-intervention) [ Time Frame: 3 months, 12 months, 24 months ]
    Risky sexual behavior is defined as self-reported heavy petting and vaginal intercourse on electronic survey



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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • developmental delay

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578147


Contacts
Contact: Anne E. Norris, PhD, RN, FAAN 305-284-4271 aen16@miami.edu
Contact: Thalasinos D. Roxana, AS 305-284-5119 rdt8@miami.edu

Locations
United States, Florida
School of Nursing and Health Studies Recruiting
Coral Gables, Florida, United States, 33146
Contact: Anne E. Norris, PhD, RN, FAAN    305-284-4271    aen16@miami.edu   
Contact: Roxana D Thalasinos, AS    305-284-5119    rdt8@miami.edu   
Principal Investigator: Anne E Norris, PhD, RN, FAAN         
Sponsors and Collaborators
University of Miami
National Institute of Nursing Research (NINR)

Responsible Party: Anne E. Norris, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02578147     History of Changes
Other Study ID Numbers: 20140697
R01NR014851 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: September 2017

Keywords provided by Anne E. Norris, University of Miami:
risky sexual behavior
early intervention