跳至主要内容
临床试验/NCT06127277
NCT06127277Enrolling By Invitation不适用

Next4You: : A Fully Mobile Relationships Based Program for Youth in Foster Care

ETR Associates1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
500
试验地点
1
主要终点
Prevalence of choosing abstinence or the use of other contraception and/or condoms if having vaginal or anal sex in the past 3 months

研究概览

简要总结

The purpose of the study is to rigorously evaluate Next4You, an innovative, fully mobile program featuring 6 content modules, each containing 8-10 microlessons intended to reduce rates of unintended pregnancy and sexually transmitted infections (STI) and increase essential knowledge, attitudes, and skills among young people aged 16-19 currently in the foster care system in California.

详细描述

Next4You will be tested using a randomized controlled trial (RCT) involving approximately 500-600 young people ages 16-19 with former or current experience in the California foster care system. Participants will complete an online screener that will assess eligibility (age, foster youth status, county of residence, English proficiency, and access to a device that is Wi-Fi or cellular enabled). Participants will be randomly assigned to receive access to the Next4You mobile platform and its microlessons and resources or a control website containing various health promotion materials. Participants in both conditions will have four consecutive weeks to explore the content on the platform (defined as the implementation period). Self-reported survey data related to attitudes, knowledge, and behavior around romantic relationships and sexual behavior are collected at baseline, as well as 3 months and 9 months after the intervention ends.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
16 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age, foster youth status, county of residence, English proficiency, access to a digital device that is Wi-Fi and/or cellular enabled -

排除标准

  • 未提供

研究组 & 干预措施

Next4You

Experimental

Next4You is a web-based, self-paced program featuring 6 content modules, each containing 8-10 microlessons intended to reduce rates of unintended pregnancy and sexually transmitted infections (STI) and increase essential knowledge, attitudes, and skills among young people aged 16-19 currently in foster care in California. Each microlesson is 2-4 minutes with diverse content formats. Youth in the intervention condition will have unlimited access to the platform for an intensive 4-week period. During this period, engagement activities will be deployed twice weekly to draw users back into the platform for further engagement with the microlessons. Content will also be released on a schedule to encourage continued engagement. Following the intensive 4-week period, youth will retain unlimited access to the platform but will not receive reminders to engage with the content. Participants complete online surveys at baseline, as well as 3 months and 9 months after the intervention ends.

干预措施: Next4You (Behavioral)

General Health Mobile Website

Active Comparator

Youth randomized to the attention control condition will have access to a mobile-responsive website that contains digital resources focusing on nutrition, sleep, stress/anxiety, and exercise. Like the intervention group, participants in the attention control group will have unlimited access to the general health digital resources for an intensive 4-week period. Each topic area will have between 1-4 digital pamphlets (for a total of 12 pamphlets) that are downloadable and take between 2-4 minutes to read. Participants complete online surveys related to attitudes, knowledge, and behavior around romantic relationships and sexual behavior at baseline, as well as 3 months and 9 months after the intervention ends.

干预措施: Next4You (Behavioral)

结局指标

主要结局

Prevalence of choosing abstinence or the use of other contraception and/or condoms if having vaginal or anal sex in the past 3 months

时间窗: 3 months post-intervention

Measured with single-item dichotomous measure of behavior analyzed individually to assess: any consensual vaginal sex in the past 3 months (main and casual sex partners); any consensual vaginal sex with a condom in the past 3 months (main and casual sex partners); any consensual vaginal sex with birth control other than condoms in the past 3 months (main and casual sex partners); consensual anal sex in the past 3 months (main and casual sex partners); and consensual anal sex with a condom in past 3 months (main and casual sex partners).

次要结局

  • Sexual communication self-efficacy(9 months post-intervention)
  • Rates of condomless vaginal or anal sex(9 months post-intervention)
  • Sexual consent self-efficacy(9 months post-intervention)
  • Condom use attitudes/beliefs(9 months post-intervention)
  • Knowledge of health care rights and location of services(9 months post-intervention)
  • Financial literacy knowledge(9 months post-intervention)
  • Prevalence of choosing abstinence or the use of other contraception and/or condoms if having vaginal or anal sex in the past 3 months(9 months post-intervention)
  • Experiences with equity and power balance in relationships(9 months post-intervention)
  • Contraceptive use attitudes/beliefs(9 months post-intervention)
  • Experience with condom use(9 months post-intervention)
  • Knowledge of educational rights and programs(9 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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