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Recruiting NCT06990724

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

No phase Interventional Contraceptive Usage Contraception Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Videogame Intervention, Commercial game control.
Who it may be relevant to
Registry conditions: Contraceptive Usage, Contraception Behavior. Basic parameters: 15 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness Testing of a Videogame Intervention (No Baby No) to Decrease Contraception Non-use Among Adolescents: A Randomized Trial

Overview

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.

Interventions

  • Other Videogame Intervention
    No Baby No video game
  • Other Commercial game control
    Commercial video game

Primary outcome measures

  • 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 participants' contraception non-use at last sexual encounter. [Time frame: Baseline, 3-month follow-up, 9-month follow-up.]
  • 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.]
  • Change in participants' use of different types of contraception at last sexual encounter. [Time frame: Baseline, 3-month follow-up, 9-month follow-up.]
  • 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.]
  • Change in the mean number of sexual encounters over the last 3 months. [Time frame: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in the mean number of sexual partners over the last 3 months. [Time frame: 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. [Time frame: Baseline, 3-month follow-up, 9-month follow-up.]
  • 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.]
  • 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.]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Sesame Flyers International Inc. — Brooklyn
  • El Barrio Operation Fightback — New York
  • King of Kings Foundation — Queens
  • New York Center for Interpersonal Development (NYCID) — Staten Island
  • Bronx Health Link — The Bronx
  • ASPIRA — The Bronx
  • Destination Tomorrow — The Bronx

Identifiers

NCT: NCT06990724 · 24-11028189 · TP2AH000081

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗