Clinical trial NCT06127277: Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care
Official title: Next4You: : A Fully Mobile Relationships Based Program for Youth in Foster Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy Related
Adolescent Behavior
Sexually Transmitted Diseases
Keywords: Pregnancy
Adolescence
Sexually Transmitted Infections
Decision Making
Prevention Education
Lead sponsor: ETR Associates
Sponsor class: OTHER
Collaborators: name: RTI International
First posted: 2023-11-13
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

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

Exclusion Criteria:

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Primary outcomes:
measure: Prevalence of choosing abstinence or the use of other contraception and/or condoms if having vaginal or anal sex in the past 3 months
timeFrame: 3 months post-intervention
Secondary outcomes:
measure: Prevalence of choosing abstinence or the use of other contraception and/or condoms if having vaginal or anal sex in the past 3 months
timeFrame: 9 months post-intervention
measure: Rates of condomless vaginal or anal sex
timeFrame: 3 months post-intervention
measure: Rates of condomless vaginal or anal sex
timeFrame: 9 months post-intervention
measure: Sexual consent self-efficacy
timeFrame: 3 months post-intervention
measure: Sexual consent self-efficacy
timeFrame: 9 months post-intervention
measure: Sexual communication self-efficacy
timeFrame: 3 months post-intervention
measure: Sexual communication self-efficacy
timeFrame: 9 months post-intervention
measure: Condom use attitudes/beliefs
timeFrame: 3 months post-intervention
measure: Condom use attitudes/beliefs
timeFrame: 9 months post-intervention
measure: Contraceptive use attitudes/beliefs
timeFrame: 3 months post-intervention
measure: Contraceptive use attitudes/beliefs
timeFrame: 9 months post-intervention
measure: Experiences with equity and power balance in relationships
timeFrame: 3 months post-intervention
measure: Experiences with equity and power balance in relationships
timeFrame: 9 months post-intervention
measure: Knowledge of health care rights and location of services
timeFrame: 3 months post-intervention
measure: Knowledge of health care rights and location of services
timeFrame: 9 months post-intervention
measure: Experience with condom use
timeFrame: 3 months post-intervention
measure: Experience with condom use
timeFrame: 9 months post-intervention
measure: Knowledge of educational rights and programs
timeFrame: 3 months post-intervention
measure: Knowledge of educational rights and programs
timeFrame: 9 months post-intervention
measure: Financial literacy knowledge
timeFrame: 3 months post-intervention
measure: Financial literacy knowledge
timeFrame: 9 months post-intervention
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: RTI
state: California
Study officials:
affiliation: ETR
name: Pamela Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ETR
name: Karin Coyle, PhD
role: PRINCIPAL_INVESTIGATOR
References: