Effectiveness Testing of a Videogame Intervention (No Baby No) to Decrease Contraception Non-use Among Adolescents.

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.

Study Overview

• Status: Recruiting
• Conditions: Contraception Behavior; Contraceptive Usage
• Intervention / Treatment: Other: Videogame Intervention; Other: Commercial game control

• Study Type: Interventional
• Enrollment (Estimated): 850
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miah Roberts Miah Roberts; Phone Number: (347)366-0286; Email: mir4017@med.cornell.edu
• Study Contact Backup: Name: Aileen Gariepy; Phone Number: (212)746-3154; Email: amg4013@med.cornell.edu

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11203
      • Recruiting
      • Sesame Flyers International Inc.
    • New York, New York, United States, 10035
      • Recruiting
      • El Barrio Operation Fightback
    • Queens, New York, United States, 11433
      • Recruiting
      • King of Kings Foundation
    • Staten Island, New York, United States, 10301
      • Recruiting
      • New York Center for Interpersonal Development (NYCID)
    • The Bronx, New York, United States, 10451
      • Not yet recruiting
      • Bronx Health Link
    • The Bronx, New York, United States, 10454
      • Recruiting
      • ASPIRA
    • The Bronx, New York, United States, 10455
      • Recruiting
      • Destination Tomorrow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No Baby No Videogame Intervention; Participants randomized to video game intervention for 120 minutes over two sessions within two weeks.	Other: Videogame Intervention; No Baby No video game
Sham Comparator: Commercial game control; Participants randomized to commercial game intervention for 120 minutes over two sessions within two weeks.	Other: Commercial game control; Commercial video game

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	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.	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.	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.	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.	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.	Baseline, 3-month follow-up, 9-month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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).	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).	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).	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).	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).	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".	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".	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".	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".	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".	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".	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).	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).	Baseline

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Department of Health and Human Services
• Investigators: Principal Investigator: Aileen Gariepy, MD, MPH, MHS, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: May 15, 2025
• First Submitted That Met QC Criteria: May 15, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Reproductive Behavior; Contraception Behavior
• Other Study ID Numbers: 24-11028189; TP2AH000081 (Other Grant/Funding Number: Department of Health and Human Services)

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
• product manufactured in and exported from the U.S.: No