JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls

September 27, 2019 updated by: Anne E. Norris, University of Miami
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
552

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33146
        • School of Nursing and Health Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • developmental delay

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in sexual intentions from baseline (pre-intervention)
Time Frame: 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.
baseline, 3 months, 12 months, 24 months
Change in risky sexual behavior from baseline (pre-intervention)
Time Frame: 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.
baseline, 3 months, 12 months, 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in sexual intentions from baseline (pre-intervention) as affected by the change in peer resistance self-efficacy
Time Frame: baseline, 3 months, 12 months, 24 months
Peer resistance self-efficacy is defined as the change in a score from 1 (disagree strongly) to 4 (agree strongly) to resist peer pressure to engage in sexual behavior and/or put oneself at risk to be exposed to other teens engaging in risky sexual behavior on an electronic survey.
baseline, 3 months, 12 months, 24 months
Change in sexual intentions from baseline (pre-intervention) as affected by implementation quality
Time Frame: baseline, 3 months, 12 months, 24 months
Implementation quality is defined as the amount of participant engagement, intervener engagement, quality of intervener delivery, and content adherence (fidelity) on a score of 0 to 100.
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
Time Frame: baseline, 3 months, 12 months, 24 months
Peer resistance self-efficacy is defined as the change in a score from 1 (disagree strongly) to 4 (agree strongly) to resist peer pressure to engage in sexual behavior and/or put oneself at risk to be exposed to other teens engaging in risky sexual behavior on electronic survey.
baseline, 3 months, 12 months, 24 months
Change in risky sexual behavior from baseline (pre-intervention) as affected by implementation quality
Time Frame: baseline, 3 months, 12 months, 24 months
Implementation quality is defined as the amount of participant engagement, intervener engagement, quality of intervener delivery, and content adherence (fidelity) on a score of 0 to 100.
baseline, 3 months, 12 months, 24 months
Costs of implementation of the intervention
Time Frame: 4 months
Costs of implementation are defined as participant transportation home from school intervention site; participant snacks; intervener salary (training, delivery, commuting time); intervention supplies, materials, and equipment; support from school personnel at the study site.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne E Norris, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20140697
  • R01NR014851 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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