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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02578147
Other study ID # 20140697
Secondary ID R01NR014851
Status Terminated
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date December 2018

Study information

Verified date September 2019
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 552
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 11 Years to 14 Years
Eligibility Inclusion Criteria:

- English Speaking

- enrolled in 7th grade at a participating school

Exclusion Criteria:

- developmental delay

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mighty Girls

Game Girls


Locations

Country Name City State
United States School of Nursing and Health Studies Coral Gables Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in sexual intentions from baseline (pre-intervention) 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
Primary Change in risky sexual behavior from baseline (pre-intervention) 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 Change in sexual intentions from baseline (pre-intervention) as affected by the change in peer resistance self-efficacy 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
Secondary Change in sexual intentions from baseline (pre-intervention) as affected by implementation quality 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
Secondary Change in risky sexual behavior from baseline (pre-intervention) as affected by the change in peer resistance self-efficacy 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
Secondary Change in risky sexual behavior from baseline (pre-intervention) as affected by implementation quality 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
Secondary Costs of implementation of the intervention 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
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