JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls

Adolescent Behavior Clinical Trial

Official title:

JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02578147
• Other study ID #: 20140697
• Secondary ID: R01NR014851
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adolescent Behavior

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