Contraceptive UsageNCT06990724
Effectiveness Testing of a Videogame Intervention (No Baby No) to Decrease Contraception Non-use Among Adolescents.
A study testing Videogame Intervention in people with Contraceptive Usage and Contraception Behavior, run by Weill Medical College of Cornell University at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a videogame compared to an attention/time control at reducing contraceptive non-use among adolescents. Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage, Contraception Behavior
- What is being tested?
- Videogame Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 850 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Jun 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or Female
- Age15-20 at the time of enrollment
- Able to speak and read English or Spanish
- Have a smart phone (to scan QR code) or personal email account (to take screening questionnaire)
Who cannot join
- Age less than 15 or older than 20
- Unable to speak and read English or Spanish
- Do not have a smart phone or personal email account
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Sesame Flyers International Inc.
Brooklyn, New York, 11203
- Recruiting
El Barrio Operation Fightback
New York, New York, 10035
- Recruiting
King of Kings Foundation
Queens, New York, 11433
- Recruiting
New York Center for Interpersonal Development (NYCID)
Staten Island, New York, 10301
- Not yet recruiting
Bronx Health Link
The Bronx, New York, 10451
- Recruiting
ASPIRA
The Bronx, New York, 10454
- Recruiting
Destination Tomorrow
The Bronx, New York, 10455
About this study
Official title: Effectiveness Testing of a Videogame Intervention (No Baby No) to Decrease Contraception Non-use Among Adolescents: A Randomized Trial
The purpose of this study is to evaluate the effectiveness of a videogame compared to an attention/time control at reducing contraceptive non-use among adolescents.
- Conditions
- Contraceptive Usage, Contraception Behavior
- Being tested
- Videogame Intervention, Commercial game control
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videogame InterventionOther
No Baby No video game
Commercial game controlOther
Commercial video game
| Study group | Role | What they receive |
|---|---|---|
| No Baby No Videogame Intervention | Experimental | Participants randomized to video game intervention for 120 minutes over two sessions within two weeks. Receives: Other: Videogame Intervention |
| Commercial game control | Sham comparator | Participants randomized to commercial game intervention for 120 minutes over two sessions within two weeks. Receives: Other: Commercial game control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean frequency of participants' contraception non-use over the last 3 months.
Change in mean frequency of how often participants had penile/vaginal sex without a condom or birth control (pregnancy prevention), as self-reported on a customized survey with multiple-choice questions adapted from the Youth Risk Behavior Survey (YRBS). Scale values range from once to five or more times, with higher scores indicating a "worse" outcome. Scores are not being reported. At baseline, 2 weeks, and 9-month follow-up participants will be asked about the prior 3 months.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in mean frequency of participants' contraception non-use at last sexual encounter.
Change in mean frequency of how often participants had penile/vaginal sex without a condom or birth control (pregnancy prevention), as self-reported on a customized survey with multiple-choice questions adapted from the Youth Risk Behavior Survey (YRBS). Scale values range from once to five or more times, with higher scores indicating a "worse" outcome. Scores are not being reported. At baseline, 2 weeks, and 9-month follow-up participants will be asked about their last sexual encounter.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in participants' use of different types of contraception over the last 3 months.
A change in the mean use of less effective- (withdrawal, condom with or without spermicide, spermicide alone, fertility-based awareness, diaphragm, sponge), more effective- (pill, patch, vaginal ring, injection, intrauterine device, implant), and dual method (condom + other) contraception use during sexual encounters as self-reported on a customized survey with multiple-choice questions adapted from the Youth Risk Behavior Survey (YRBS). Participants select all forms of contraception that they used, with response options also including "No method was used to prevent pregnancy or STIs". At baseline, 2 weeks, and 9-month follow-up participants will be asked about the prior 3 months
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in participants' use of different types of contraception at last sexual encounter.
A change in the mean use of less effective- (withdrawal, condom with or without spermicide, spermicide alone, fertility-based awareness, diaphragm, sponge), more effective- (pill, patch, vaginal ring, injection, intrauterine device, implant), and dual method (condom + other) contraception use during sexual encounters as self-reported on a customized survey with multiple-choice questions adapted from the Youth Risk Behavior Survey (YRBS). At baseline, 2 weeks, and 9-month follow-up participants will be asked about their last sexual encounter.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in number of participants abstaining from having sex over the last 3 months.
A change in the number of participants who abstained from having sex as self-reported on a customized survey with multiple-choice questions adapted from the Youth Risk Behavior Survey (YRBS). At baseline, 2 weeks, and 9-month follow-up participants will be asked about the prior 3 months.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in the mean number of sexual encounters over the last 3 months.
A change in the mean number of times participants had penile/vaginal sex as self-reported on a customized survey with a multiple-choice survey question adapted from the Youth Risk Behavior Survey (YRBS). At baseline, 2 weeks, and 9-month follow-up participants will be asked about the prior 3 months.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in the mean number of sexual partners over the last 3 months.
A change in participants mean number of self-reported sexual partners, as reflected by their answer to a multiple-choice survey question adapted from the Youth Risk Behavior Survey (YRBS). At baseline, 2 weeks, and 9-month follow-up participants will be asked about the prior 3 months.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in the number of participants who use alcohol and/or take drugs before sex at last sexual encounter.
Change in the number of participants who self-report drinking alcohol or using drugs before having sex, based on Yes/No responses to a question adapted from the Youth Risk Behavior Survey (YRBS). At baseline, 2 weeks, and 9-month follow-up participants will be asked about the last sexual encounter.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in the number of participants with a positive STI (Sexually Transmitted infection) test result.
A change in the number of participants who self-report ever receiving a positive STI result on a customized survey as adapted by YRBSS Questionnaire. At baseline, 2 weeks, and 9-month follow-up participants will be asked if they have ever received a positive STI (Sexually Transmitted infection) test result.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in the number of participants with a positive pregnancy test result for themselves or a partner.
A change in the number of participants who self-report ever receiving a positive pregnancy test result or report their partner ever receiving a positive pregnancy test result, as documented by a Yes/No question on a customized survey. At baseline, 2 weeks, and 9-month follow-up participants will be asked if they/their partner have ever received a positive pregnancy test result.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Secondary outcomes (21)
Change in participants' intentions for contraception non-use over the next year, as indicated by participants' mean responses to a survey question.
A change in the mean Likert-scale rating of participants on a survey item asking about their commitment to using contraception adapted from existing literature. At baseline, 2 weeks, and 9-month follow-up participants will be asked about their commitment to using contraception.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in participants' self-efficacy regarding condom use, as indicated by their mean rating on a survey question.
A change in the mean 5-point Likert-scale rating (anchor points "I strongly agree" to "I strongly disagree") on a survey item by participants reflecting their degree of confidence in correctly and consistently using condoms. The survey question is adapted from existing literature. At baseline, 2 weeks, and 9-month follow-up participants will be asked about their confidence in condom usage.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in participants' self-efficacy regarding contraception use, as indicated by their mean ratings on a survey question.
A change in the mean survey-item rating by participants reflecting their degree of confidence in correctly and consistently using contraception using a question adapted from existing literature. At baseline, 2 weeks, and 9-month follow-up participants will be asked about their confidence in contraception use.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in participants' perceptions of sexual risk (susceptibility to getting an STI), as indicated by their mean rating on a survey question.
A change in the mean survey-item rating by participants reflecting their perceived likelihood of getting an STI, based on contraception non-use, using a question adapted from existing literature. At baseline, 2 weeks, and 9-month follow-up participants will be asked of their perceived likelihood of getting an STI.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in participants' perceptions of sexual risk (getting pregnant/getting a partner pregnant), as indicated by their mean rating on a survey question.
A change in the mean survey-item rating by participants reflecting their perceived likelihood of getting pregnant (or getting a partner pregnant), based on contraception non-use, using a question adapted from existing literature. Anchor points on the 5-point Likert scale range from "I strongly agree" to "I strongly disagree". At baseline, 2 weeks, and 9-month follow-up participants will be asked about their perceived likelihood of getting pregnant/their partner pregnant if they didn't use contraception.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Change in participants' sexual knowledge, as reflected by their mean scores on a sexual knowledge questionnaire.
A change in participants' mean scores on questionnaire items assessing their sexual knowledge (STIs, pregnancy and contraception) using questions adapted from existing literature. Sexual knowledge questionnaire items completed by participants at baseline, 2 weeks, and 9-month follow-up.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
A change in the number of participants who visit a clinic to obtain contraception or to undergo sexually transmitted infection (STI) screening over the past 3 months.
A change in the number of participants self-reporting visiting a clinic or doctor's office to discuss or get contraception or STI screening using a question adapted from existing literature. Participants reported at baseline, 2 weeks, and 9-month follow-up.
Measured: Baseline, 3-month follow-up, 9-month follow-up.
Assessment of the fidelity of program delivery based on duration of No Baby No game play.
Assessment of the mean duration that each participant plays the No Baby No game over two game-play sessions (Baseline and approximately 1 week follow-up), as captured by the video game.
Measured: Baseline
Assessment of the fidelity of program delivery based on number of interruptions to No Baby No game play.
Assessment of the average number of interruptions to game play per participant (number of times participant leaves the room or has to be redirected to play the game), as hand-recorded by research assistants over two gameplay sessions (Baseline and approximately 1 week follow-up).
Measured: Baseline
Assessment of the quality of No Baby No program delivery, as indicated by the average number of technological failures during the game-play experience.
Assessment of the average number of technological failures during No-Baby No game play (internet-, tablet- or game failures) as hand-recorded by research assistants on game-play session checklists over two game play sessions (Baseline and approximately 1 week follow-up).
Measured: Baseline
Assessment of the quality of No Baby No program delivery, as measured by the average number of minutes of game play.
Average number of minutes of game play across each of two game-play sessions, as captured by the No Baby No video game (Baseline and approximately 1 week follow-up).
Measured: Baseline
Assessment of the quality of No Baby No program delivery, as measured by the average number of game play sessions attended by participants.
Average number of game play sessions attended by participants out of a maximum total of two), as captured by the No Baby No video game (Baseline and approximately 1 week follow-up).
Measured: Baseline
Assessment of the quality of No Baby No program receipt, as measured by participants' average satisfaction with the game-play experience.
Assessment of participants' average satisfaction with the No Baby No gameplay experience, as rated on a 5-Point Likert scale after each of two game-play sessions (Baseline and approximately 1 week follow-up).
Measured: Baseline
Assessment of participants' responsiveness to the No Baby No video game, as measured by their average enjoyment rating for the game.
Assessment of participants' average response to a multiple-choice questionnaire item asking about how much they enjoyed playing the game at two gameplay sessions (Baseline and approximately 1 week follow-up). Response options to the question "I enjoyed playing the game" are on a 5-point Likert scale with anchor points of "I strongly agree" and "I strongly disagree".
Measured: Baseline
Assessment of participants' responsiveness to the No Baby No video game, as measured by their average helpfulness rating for the game.
Assessment of participants' average response to a multiple-choice questionnaire item asking about how helpful they found the game at two gameplay sessions (Baseline and approximately 1 week follow-up). Response options to the question "I found the game helpful" are on a 5-point Likert scale with anchor points of "I strongly agree" and "I strongly disagree".
Measured: Baseline
Assessment of participants' responsiveness to the No Baby No video game, as measured by their average rating of connection with the characters from the game.
Assessment of participants' average response to a multiple-choice questionnaire item asking about how connected they were to the characters in the game at two gameplay sessions (Baseline and approximately 1 week follow-up). Response options to the question "I felt connected to the characters in the game" are on a 5-point Likert scale with anchor points of "I strongly agree" and "I strongly disagree".
Measured: Baseline
Assessment of participants' responsiveness to the No Baby No video game, as measured by their average rating of likelihood of playing the game again.
Assessment of participants' average response to a multiple-choice questionnaire item asking how likely they would be to play the game again, if given the choice. Question completed at two gameplay sessions (Baseline and approximately 1 week follow-up). Response options to the question "I would play the game again" are on a 5-point Likert scale with anchor points of "I strongly agree" and "I strongly disagree".
Measured: Baseline
Assessment of the acceptability of the No Baby No video game to participants, as measured by their average rating of comprehension of game content.
Assessment of participants' average response to a multiple-choice questionnaire item asking about how easy the content of the game was to understand. Question completed at two gameplay sessions (Baseline and approximately 1 week follow-up). Response options to the question "I found the content in the game easy to understand" are on a 5-point Likert scale with anchor points of "I strongly agree" and "I strongly disagree".
Measured: Baseline
Assessment of the acceptability of the No Baby No video game to participants, as measured by their average rating of the game's usefulness.
Assessment of participants' average response to a multiple-choice questionnaire item asking about how useful the game was in helping participants to make real-life decisions. Question completed at two gameplay sessions (Baseline and approximately 1 week follow-up). Response options to the question "I found the game useful in helping me to make decisions in real life" are on a 5-point Likert scale with anchor points of "I strongly agree" and "I strongly disagree".
Measured: Baseline
Qualitative assessment of the feasibility of the program delivery protocol for the No Baby No game, as evidenced by resource sufficiency.
Assessment of whether the resources provided for game-play sessions were sufficient, as documented through meeting minutes from twice-weekly team meetings with research personnel facilitating No Baby No game-play sessions (at Baseline and approximately 1 week follow-up).
Measured: Baseline
Qualitative assessment of facilitators and barriers to No Baby No videogame delivery (feasibility metrics).
Assessment of facilitators and barriers to program delivery, as documented through meeting minutes from twice-weekly team meetings with research personnel facilitating No Baby No game-play sessions (at Baseline and approximately 1 week follow-up).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start11 Jun 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Aileen Gariepy, MD, MPH, MHS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990724
- Sponsor's protocol ID
- 24-11028189
- Other IDs
- TP2AH000081
- Status last verified
- Dec 2025
- First submitted
- 15 May 2025
- Last updated
- 22 Dec 2025
- 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Testing of a Videogame Intervention (No Baby No) to Decrease Contraception Non-use Among Adolescents: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06990724
- Acronym / sponsor ID
- 24-11028189
- Conditions
- Contraceptive Usage, Contraception Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- 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 evaluate the effectiveness of a videogame compared to an attention/time control at reducing contraceptive non-use among adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Baby No Videogame Intervention | Experimental | Other: Videogame InterventionParticipants randomized to video game intervention for 120 minutes over two sessions within two weeks. |
| Commercial game control | Sham comparator | Other: Commercial game controlParticipants randomized to commercial game intervention for 120 minutes over two sessions within two weeks. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male or Female
- Age15-20 at the time of enrollment
- Able to speak and read English or Spanish
- Have a smart phone (to scan QR code) or personal email account (to take screening questionnaire)
Key exclusion criteria (3 listed)
- Age less than 15 or older than 20
- Unable to speak and read English or Spanish
- Do not have a smart phone or personal email account
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 |
|---|---|---|
| Videogame InterventionNo Baby No video game | Other | No Baby No Videogame Intervention |
| Commercial game controlCommercial video game | Other | Commercial game control |
Primary outcome
Change in mean frequency of participants' contraception non-use over the last 3 months.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
Change in mean frequency of how often participants had penile/vaginal sex without a condom or birth control (pregnancy prevention), as self-reported on a customized survey with multiple-choice questions adapted from the Youth Risk Behavior Survey (YRBS). Scale values range from once to five or more times, with higher scores indicating a "worse" outcome. Scores are not being reported. At baseline, 2 weeks, and 9-month follow-up participants will be asked about the prior 3 months.
Change in mean frequency of participants' contraception non-use at last sexual encounter.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
Change in mean frequency of how often participants had penile/vaginal sex without a condom or birth control (pregnancy prevention), as self-reported on a customized survey with multiple-choice questions adapted from the Youth Risk Behavior Survey (YRBS). Scale values range from once to five or more times, with higher scores indicating a "worse" outcome. Scores are not being reported. At baseline, 2 weeks, and 9-month follow-up participants will be asked about their last sexual encounter.
Change in participants' use of different types of contraception over the last 3 months.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
A change in the mean use of less effective- (withdrawal, condom with or without spermicide, spermicide alone, fertility-based awareness, diaphragm, sponge), more effective- (pill, patch, vaginal ring, injection, intrauterine device, implant), and dual method (condom + other) contraception use during sexual encounters as self-reported on a customized survey with multiple-choice questions adapted from the Youth Risk Behavior Survey (YRBS). Participants select all forms of contraception that they used, with response options also including "No method was used to prevent pregnancy or STIs". At baseline, 2 weeks, and 9-month follow-up participants will be asked about the prior 3 months
Change in participants' use of different types of contraception at last sexual encounter.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
A change in the mean use of less effective- (withdrawal, condom with or without spermicide, spermicide alone, fertility-based awareness, diaphragm, sponge), more effective- (pill, patch, vaginal ring, injection, intrauterine device, implant), and dual method (condom + other) contraception use during sexual encounters as self-reported on a customized survey with multiple-choice questions adapted from the Youth Risk Behavior Survey (YRBS). At baseline, 2 weeks, and 9-month follow-up participants will be asked about their last sexual encounter.
Change in number of participants abstaining from having sex over the last 3 months.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
A change in the number of participants who abstained from having sex as self-reported on a customized survey with multiple-choice questions adapted from the Youth Risk Behavior Survey (YRBS). At baseline, 2 weeks, and 9-month follow-up participants will be asked about the prior 3 months.
Change in the mean number of sexual encounters over the last 3 months.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
A change in the mean number of times participants had penile/vaginal sex as self-reported on a customized survey with a multiple-choice survey question adapted from the Youth Risk Behavior Survey (YRBS). At baseline, 2 weeks, and 9-month follow-up participants will be asked about the prior 3 months.
Change in the mean number of sexual partners over the last 3 months.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
A change in participants mean number of self-reported sexual partners, as reflected by their answer to a multiple-choice survey question adapted from the Youth Risk Behavior Survey (YRBS). At baseline, 2 weeks, and 9-month follow-up participants will be asked about the prior 3 months.
Change in the number of participants who use alcohol and/or take drugs before sex at last sexual encounter.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
Change in the number of participants who self-report drinking alcohol or using drugs before having sex, based on Yes/No responses to a question adapted from the Youth Risk Behavior Survey (YRBS). At baseline, 2 weeks, and 9-month follow-up participants will be asked about the last sexual encounter.
Change in the number of participants with a positive STI (Sexually Transmitted infection) test result.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
A change in the number of participants who self-report ever receiving a positive STI result on a customized survey as adapted by YRBSS Questionnaire. At baseline, 2 weeks, and 9-month follow-up participants will be asked if they have ever received a positive STI (Sexually Transmitted infection) test result.
Change in the number of participants with a positive pregnancy test result for themselves or a partner.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
A change in the number of participants who self-report ever receiving a positive pregnancy test result or report their partner ever receiving a positive pregnancy test result, as documented by a Yes/No question on a customized survey. At baseline, 2 weeks, and 9-month follow-up participants will be asked if they/their partner have ever received a positive pregnancy test result.
21 secondary outcomes
Change in participants' intentions for contraception non-use over the next year, as indicated by participants' mean responses to a survey question.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
Change in participants' self-efficacy regarding condom use, as indicated by their mean rating on a survey question.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
Change in participants' self-efficacy regarding contraception use, as indicated by their mean ratings on a survey question.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
Change in participants' perceptions of sexual risk (susceptibility to getting an STI), as indicated by their mean rating on a survey question.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
Change in participants' perceptions of sexual risk (getting pregnant/getting a partner pregnant), as indicated by their mean rating on a survey question.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
Change in participants' sexual knowledge, as reflected by their mean scores on a sexual knowledge questionnaire.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
A change in the number of participants who visit a clinic to obtain contraception or to undergo sexually transmitted infection (STI) screening over the past 3 months.
Time frame: Baseline, 3-month follow-up, 9-month follow-up.
Assessment of the fidelity of program delivery based on duration of No Baby No game play.
Time frame: Baseline
Assessment of the fidelity of program delivery based on number of interruptions to No Baby No game play.
Time frame: Baseline
Assessment of the quality of No Baby No program delivery, as indicated by the average number of technological failures during the game-play experience.
Time frame: Baseline
Assessment of the quality of No Baby No program delivery, as measured by the average number of minutes of game play.
Time frame: Baseline
Assessment of the quality of No Baby No program delivery, as measured by the average number of game play sessions attended by participants.
Time frame: Baseline
Assessment of the quality of No Baby No program receipt, as measured by participants' average satisfaction with the game-play experience.
Time frame: Baseline
Assessment of participants' responsiveness to the No Baby No video game, as measured by their average enjoyment rating for the game.
Time frame: Baseline
Assessment of participants' responsiveness to the No Baby No video game, as measured by their average helpfulness rating for the game.
Time frame: Baseline
Assessment of participants' responsiveness to the No Baby No video game, as measured by their average rating of connection with the characters from the game.
Time frame: Baseline
Assessment of participants' responsiveness to the No Baby No video game, as measured by their average rating of likelihood of playing the game again.
Time frame: Baseline
Assessment of the acceptability of the No Baby No video game to participants, as measured by their average rating of comprehension of game content.
Time frame: Baseline
Assessment of the acceptability of the No Baby No video game to participants, as measured by their average rating of the game's usefulness.
Time frame: Baseline
Qualitative assessment of the feasibility of the program delivery protocol for the No Baby No game, as evidenced by resource sufficiency.
Time frame: Baseline
Qualitative assessment of facilitators and barriers to No Baby No videogame delivery (feasibility metrics).
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- 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.
Aileen Gariepy, MD, MPH, MHS principal investigator
Weill Medical College of Cornell University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videogame Intervention in people with Contraceptive Usage and Contraception Behavior, run by Weill Medical College of Cornell University at 7 sites 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miah Roberts Miah Roberts ((347)366-0286, mir4017@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean frequency of participants' contraception non-use over the last 3 months. (time frame: Baseline, 3-month follow-up, 9-month follow-up.). The study lists 10 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 22 Dec 2025.