Evaluating the efficacy of an online, family-based intervention to promote adolescent sexual health: a study protocol for a randomized controlled trial

BACKGROUND: Adolescents in the U.S. experience significant negative sexual health outcomes, representing a public health priority in the U.S. Research shows that while parents play an influential role in shaping adolescent sexual behavior, surprisingly few programs engage parents in existing programming. Moreover, most efficacious parent-based programs focus on young adolescents, and few utilize delivery mechanisms that facilitate broad reach and scale-up. To address these gaps, we propose to test the efficacy of an online-delivered, parent-based intervention adapted to address both younger and older adolescent sexual risk behavior. METHODS: In this parallel, two-arm, superiority randomized controlled trial (RCT), we propose to evaluate Families Talking Together Plus (FTT+), an adaptation of an existing and efficacious FTT parent-based intervention, in shaping sexual risk behavior among adolescents aged 12–17 and delivered via a teleconferencing application (e.g., Zoom). The study population will include n=750 parent–adolescent dyads recruited from public housing developments in the Bronx, New York. Adolescents will be eligible if they are between the ages of 12 and 17 years of age, self-report as Latino and/or Black, have a parent or primary caregiver, and are South Bronx residents. Parent–adolescent dyads will complete a baseline survey, after which they will be assigned to either the FTT+ intervention condition (n=375) or the passive control condition (n=375) in a 1:1 allocation ratio. Parents and adolescents in each condition will complete follow-up assessments 3 and 9 months post-baseline. The primary outcomes will include sexual debut and ever sex, and the secondary outcomes will include the frequency of sex acts, number of lifetime sexual partners, number of unprotected sex acts, and linkage to health and educational/vocational services in the community. We will utilize intent-to-treat analyses of 9-month outcomes and single degree of freedom contrasts comparing the intervention to the control group for primary and secondary outcomes. DISCUSSION: The proposed evaluation and analysis of the FTT+ intervention will address gaps in the current cadre of parent-based programs. If efficacious, FTT+ would represent a model for scale-up and adoption of parent-based approaches designed to address adolescent sexual health in the U.S. TRIAL REGISTRATION: ClinicalTrials.gov NCT04731649. Registered on February 1, 2021.