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

NCT06990724 | Recruiting

• 2 other identifiers: 24-11028189TP2AH000081
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Contraceptive Usage; Contraception Behavior

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (21)

• Change in participants' intentions for contraception non-use over the next year, as indicated by participants' mean responses to a survey question.

  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.

  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.

  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.

  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.

  Baseline, 3-month follow-up, 9-month follow-up.

Study Arms (2)

No Baby No Videogame Intervention

EXPERIMENTAL

Participants randomized to video game intervention for 120 minutes over two sessions within two weeks.

Other: Videogame Intervention

Commercial game control

SHAM COMPARATOR

Participants randomized to commercial game intervention for 120 minutes over two sessions within two weeks.

Other: Commercial game control

Interventions

Commercial game control OTHER

Commercial video game

Commercial game control

Videogame Intervention OTHER

No Baby No video game

No Baby No Videogame Intervention

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Department of Health and Human Services: collaborator

Study Sites (7)

Sesame Flyers International Inc.

Brooklyn, New York, 11203, United States

RECRUITING

El Barrio Operation Fightback

New York, New York, 10035, United States

RECRUITING

King of Kings Foundation

Queens, New York, 11433, United States

RECRUITING

New York Center for Interpersonal Development (NYCID)

Staten Island, New York, 10301, United States

RECRUITING

Bronx Health Link

The Bronx, New York, 10451, United States

NOT YET RECRUITING

ASPIRA

The Bronx, New York, 10454, United States

RECRUITING

Destination Tomorrow

The Bronx, New York, 10455, United States

RECRUITING

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• Aileen Gariepy, MD, MPH, MHS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miah Roberts Miah Roberts

CONTACT

(347)366-0286; mir4017@med.cornell.edu

Aileen Gariepy

CONTACT

(212)746-3154; amg4013@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 25, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)