Clinical trial NCT06990724: Effectiveness Testing of a Videogame Intervention (No Baby No) to Decrease Contraception Non-use Among Adolescents.
Official title: Effectiveness Testing of a Videogame Intervention (No Baby No) to Decrease Contraception Non-use Among Adolescents: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Contraceptive Usage
Contraception Behavior
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2025-05-25
Enrollment: 850
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in mean frequency of participants' contraception non-use over the last 3 months.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in mean frequency of participants' contraception non-use at last sexual encounter.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in participants' use of different types of contraception over the last 3 months.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in participants' use of different types of contraception at last sexual encounter.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in number of participants abstaining from having sex over the last 3 months.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in the mean number of sexual encounters over the last 3 months.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in the mean number of sexual partners over the last 3 months.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in the number of participants who use alcohol and/or take drugs before sex at last sexual encounter.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in the number of participants with a positive STI (Sexually Transmitted infection) test result.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in the number of participants with a positive pregnancy test result for themselves or a partner.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
Secondary outcomes:
measure: Change in participants' intentions for contraception non-use over the next year, as indicated by participants' mean responses to a survey question.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in participants' self-efficacy regarding condom use, as indicated by their mean rating on a survey question.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in participants' self-efficacy regarding contraception use, as indicated by their mean ratings on a survey question.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in participants' perceptions of sexual risk (susceptibility to getting an STI), as indicated by their mean rating on a survey question.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in participants' perceptions of sexual risk (getting pregnant/getting a partner pregnant), as indicated by their mean rating on a survey question.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Change in participants' sexual knowledge, as reflected by their mean scores on a sexual knowledge questionnaire.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: 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.
timeFrame: Baseline, 2-week follow-up, 9-month follow-up.
measure: Assessment of the fidelity of program delivery based on duration of No Baby No game play.
timeFrame: Baseline, Approximately 1 week follow-up
measure: Assessment of the fidelity of program delivery based on number of interruptions to No Baby No game play.
timeFrame: Baseline, Approximately 1 week follow-up
measure: Assessment of the quality of No Baby No program delivery, as indicated by the average number of technological failures during the game-play experience.
timeFrame: Baseline, Approximately 1 week follow-up
measure: Assessment of the quality of No Baby No program delivery, as measured by the average number of minutes of game play.
timeFrame: Baseline, Approximately 1 week follow-up
measure: Assessment of the quality of No Baby No program delivery, as measured by the average number of game play sessions attended by participants.
timeFrame: Baseline, Approximately 1 week follow-up
measure: Assessment of the quality of No Baby No program receipt, as measured by participants' average satisfaction with the game-play experience.
timeFrame: Baseline, Approximately 1 week follow-up
measure: Assessment of participants' responsiveness to the No Baby No video game, as measured by their average enjoyment rating for the game.
timeFrame: Baseline, Approximately 1 week follow-up
measure: Assessment of participants' responsiveness to the No Baby No video game, as measured by their average helpfulness rating for the game.
timeFrame: Baseline, Approximately 1 week follow-up
measure: 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.
timeFrame: Baseline, Approximately 1 week follow-up
measure: Assessment of participants' responsiveness to the No Baby No video game, as measured by their average rating of likelihood of playing the game again.
timeFrame: Baseline, Approximately 1 week follow-up
measure: Assessment of the acceptability of the No Baby No video game to participants, as measured by their average rating of comprehension of game content.
timeFrame: Baseline, Approximately 1 week follow-up
measure: Assessment of the acceptability of the No Baby No video game to participants, as measured by their average rating of the game's usefulness.
timeFrame: Baseline, Approximately 1 week follow-up
measure: Qualitative assessment of the feasibility of the program delivery protocol for the No Baby No game, as evidenced by resource sufficiency.
timeFrame: Baseline, Approximately 1 week follow-up
measure: Qualitative assessment of facilitators and barriers to No Baby No videogame delivery (feasibility metrics).
timeFrame: Baseline, Approximately 1 week follow-up
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx Health Link
state: New York
city: Bronx
country: United States
facility: Destination Tomorrow
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Aileen Gariepy, MD, MPH, MHS
role: PRINCIPAL_INVESTIGATOR
References: