JMIR Publications

ABSTRACT

Background:

Romantic relationships play a critical role in adolescent development and, by middle adolescence, most young people have been involved in at least 1 romantic relationship, a context in which most sexual interactions occur. Research suggests adolescents lack positive models and skills related to building healthy relationships.

Objective:

The goal of this project is to test the impact of an innovative healthy relationships intervention, called About Us, being implemented in school-based health centers (SBHCs) in California, in a randomized controlled trial (RCT).

Methods:

About Us is being tested using a 7-site, 2-group, parallel RCT with a treatment/control allocation ratio of 3:2 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 3 survey timepoints: baseline, 3-months post-intervention, and 9-months post-intervention. 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—impact of About Us relative to the standard of care 9 months following the end of the intervention on prevalence of vaginal or anal sex without condoms in the past 3 months. The secondary outcomes are 4-fold: 3 and 9 months following the end of the intervention, what is the impact of About Us relative to the standard of care on: 2.1. Prevalence of abstinence from vaginal or anal sex in the past 3 months? 2.2. Composite scores of relationship communication and positive conflict resolution among participants involved in a relationship at baseline? 2.3. Prevalence of SBHC service use or information receipt in the past 3 months? and 2.4. Composite scores of condom use intentions and attitudes regarding condoms and other birth control? Additionally, as part of our sensitivity analyses, 2 additional types of 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 (PREIS) 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 continues 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. The COVID-19 pandemic restrictions led to school closures, interruptions to ongoing programming, and in-person follow-up data collection, which has affected study attrition. Clinical Trial: ClinicalTrials.gov #NCT03736876