Promoting Adolescent Healthy Relationships (The About Us Program): Protocol for a Randomized Clinical Trial.

ABSTRACT

BACKGROUND: Romantic relationships play a critical role in adolescent development, and by middle adolescence, most young people have been involved in at least one romantic relationship, a context in which most sexual interactions occur. Research suggests adolescents lack positive models and skills related to building healthy relationships. OBJECTIVE: This project aims to test the impact of an innovative healthy relationships intervention, called About Us, implemented in school-based health centers (SBHCs) in California in a randomized controlled trial. METHODS: About Us is being tested using a 7-site, 2-group, parallel randomized controlled trial with a treatment versus control allocation ratio of 32 to assess the impact of the intervention relative to the standard of care among adolescents aged 14 to 18 years. Adolescents with active parental consent provide study assent at each of the 3 survey time points baseline, 3 months postintervention, and 9 months postintervention. A stratified randomization procedure was used to ensure balance in key covariates and screening criteria across intervention groups. Through benchmark intent-to-treat analyses, we will examine the primary outcome of this study-the impact of About Us relative to the standard of care 9 months following the end of the intervention on the prevalence of vaginal or anal sex without condoms in the past 3 months. The secondary outcomes are four-fold what is the impact of About Us relative to the standard of care 3 and 9 months following the end of the intervention, on (1) the prevalence of abstinence from vaginal or anal sex in the past 3 months, (2) composite scores of relationship communication and positive conflict resolution among participants involved in a relationship at baseline, (3) the prevalence of SBHC service use or information receipt in the past 3 months, and (4) composite scores of condom use intentions and attitudes regarding condoms and other birth control? Additionally, as part of our sensitivity analyses, two additional analyses will be implemented modified intent-to-treat and complete case analysis. RESULTS: This project (ClinicalTrials.gov #NCT03736876) was funded in 2016 through the Family Youth Services Bureau as part of the Personal Responsibility Education Innovative Strategies program. Baseline data collection took place between February 2018 and March 2020, yielding a total of 5 cohorts and 533 study participants: 316 assigned to treatment and 217 assigned to control. Ongoing follow-up data collection continued through May 2021. CONCLUSIONS: About Us draws on developmental science to create a contextually and developmentally relevant program that addresses motivation and emotional influences in sexual decision-making. The intervention was designed for implementation within SBHCs, an understudied venue for relationship and sexual health promotion interventions. Unfortunately, COVID-19 pandemic restrictions led to school closures, interrupting ongoing programming, and in-person follow-up data collection, which has affected study attrition. TRIAL REGISTRATION ClinicalTrials.gov NCT03736876; https//clinicaltrials.gov/ct2/show/NCT03736876. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/30499.