Adolescent BehaviorNCT02578147
JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls
A study testing Mighty Girls and Game Girls in people with Adolescent Behavior, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior
- What is being tested?
- Mighty Girls and Game Girls
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- English Speaking
- enrolled in 7th grade at a participating school
Who cannot join
- developmental delay
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Nursing and Health Studies
Coral Gables, Florida, 33146
About this study
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.
- Conditions
- Adolescent Behavior
- Being tested
- Mighty Girls, Game Girls
- Keywords
- risky sexual behavior, early intervention, adolescent pregnancy
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mighty GirlsBehavioural
Game GirlsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mighty Girls |
| 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. Receives: Behavioral: Game Girls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3 months, 12 months, 24 months
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.
Measured: baseline, 3 months, 12 months, 24 months
Secondary outcomes (5)
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.
Measured: baseline, 3 months, 12 months, 24 months
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.
Measured: 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
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.
Measured: baseline, 3 months, 12 months, 24 months
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.
Measured: baseline, 3 months, 12 months, 24 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Funding not available to continue enrollment beyond study completion date.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Anne E. Norris, University of Miami
- Investigators
- Anne E Norris, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578147
- Sponsor's protocol ID
- 20140697
- Other IDs
- R01NR014851
- Status last verified
- Sep 2019
- First submitted
- 14 Oct 2015
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls
- ClinicalTrials.gov ID
- NCT02578147
- Acronym / sponsor ID
- 20140697
- Conditions
- Adolescent Behavior
- Keywords
- risky sexual behavior, early intervention, adolescent pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding not available to continue enrollment beyond study completion date.
- Enrolment
- 552 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mighty Girls | Experimental | Behavioral: Mighty GirlsGirls 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. |
| Game Girls | Active comparator | Behavioral: Game GirlsGirls 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. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- English Speaking
- enrolled in 7th grade at a participating school
Key exclusion criteria (1 listed)
- developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mighty Girls | Behavioural | Mighty Girls |
| Game Girls | Behavioural | Game Girls |
Primary outcome
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.
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.
5 secondary outcomes
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
Change in sexual intentions from baseline (pre-intervention) as affected by implementation quality
Time frame: 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
Change in risky sexual behavior from baseline (pre-intervention) as affected by implementation quality
Time frame: baseline, 3 months, 12 months, 24 months
Costs of implementation of the intervention
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Funding not available to continue enrollment beyond study completion date.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne E Norris, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mighty Girls and Game Girls in people with Adolescent Behavior, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding not available to continue enrollment beyond study completion date.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sexual intentions from baseline (pre-intervention) (time frame: baseline, 3 months, 12 months, 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.