Effectiveness Testing of a Videogame Intervention (No Baby No) to Decrease Contraception Non-use Among Adolescents: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 850
- 试验地点
- 8
- 主要终点
- Change in the number of participants with a positive pregnancy test result for themselves or a partner.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
No Baby No Videogame Intervention
Participants randomized to video game intervention for 120 minutes over two sessions within two weeks.
干预措施: Videogame Intervention (Other)
Commercial game control
Participants randomized to commercial game intervention for 120 minutes over two sessions within two weeks.
干预措施: Commercial game control (Other)
结局指标
主要结局
Change in the number of participants with a positive pregnancy test result for themselves or a partner.
时间窗: 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.
Change in mean frequency of participants' contraception non-use over the last 3 months.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- Assessment of the fidelity of program delivery based on duration of No Baby No game play.(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.(Baseline)
- Assessment of the quality of No Baby No program delivery, as measured by the average number of game play sessions attended by participants.(Baseline)
- Assessment of the quality of No Baby No program receipt, as measured by participants' average satisfaction with the game-play experience.(Baseline)
- Assessment of participants' responsiveness to the No Baby No video game, as measured by their average enjoyment rating for the game.(Baseline)
- Assessment of participants' responsiveness to the No Baby No video game, as measured by their average helpfulness rating for the game.(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.(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.(Baseline)
- Qualitative assessment of the feasibility of the program delivery protocol for the No Baby No game, as evidenced by resource sufficiency.(Baseline)
- Qualitative assessment of facilitators and barriers to No Baby No videogame delivery (feasibility metrics).(Baseline)
- 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.)
- Change in participants' sexual knowledge, as reflected by their mean scores on a sexual knowledge questionnaire.(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.(Baseline, 3-month follow-up, 9-month follow-up.)
- Assessment of the fidelity of program delivery based on number of interruptions to No Baby No game play.(Baseline)
- Assessment of the quality of No Baby No program delivery, as measured by the average number of minutes of game play.(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.(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.(Baseline)