Promoting Healthy Adolescent Romantic Relationships: Results of a Multisite, Two-group Parallel Randomized Clinical Trial.

PURPOSE: To examine the impact of About Us, an innovative healthy relationships intervention that promotes positive adolescent romantic relationships and the use of effective contraceptives, on improving behavior, attitudes, and intentions related to sexual intercourse, relationship communication, and conflict resolution at 3- and 9-month follow-up, compared to services as usual. METHODS: This was a multi-site, two-group, parallel, randomized-controlled trial with an intervention/comparison allocation ratio of 3:2 conducted at seven high schools in California between February 2018 and May 2021. RESULTS: Overall, our study did not find statistically significant evidence of improved behavior, attitudes, and intentions related to sexual intercourse, relationship communication, and conflict resolution among participants (14-18 years old) randomized to the intervention group (n = 316) compared to services as usual (n = 217) during follow-up (group x time; p > .05). Exploratory within group analyses showed that, compared to baseline, at the 3-month follow-up, the prevalence of reporting having had sex increased in the control group relative to intervention group (+19% vs. +9%, p < .01). Our sub-group analyses showed that changes in condom use intentions scores differed across school sites (group x time x school; p < .01); mixed (positive and negative) trends were observed for intervention effect, and schools with positive intervention effect trends tended to have greater program participation. DISCUSSION: About Us did not show statistically significant positive impacts on primary or secondary outcomes as anticipated. Our exploratory findings show evidence of some promising trends of intervention effects at the school-level, suggesting a need for better tailored intervention components and/or delivery to address the unique environmental contexts of participants. Overall, the context of study implementation was negatively affected by the COVID-19 pandemic and challenges related to using a non-classroom delivery intervention approach. Combined, these factors may have contributed to the study null findings. Moreover, it is difficult to know (or determine) the intervention's impact under more ideal conditions (i.e., no COVID pandemic).

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

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 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 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.

Condom application skills and self-efficacy in youth: A systematic review and meta-analysis.

Globally, and in the United States (U.S.) specifically, rates of reported sexually transmitted infections (STIs) have been steadily increasing and are especially high among youth aged 13-25 years. Using condoms correctly and consistently is an effective STI prevention measure for sexually active youth, yet public health endeavors tend to focus only on condom use consistency. Directly measuring condom application is challenging and expensive. Alternative tools evaluate this behaviour, but little evidence exists on the appropriateness of these instruments in measuring application skills. This systematic review and meta-analysis examined the association between condom application skills and self-efficacy. We conducted a search of several databases as well as unpublished works. Studies were included if they were in English, examined youth aged 13-25 years, and were available between 1992 and 2019. The authors screened 630 titles and abstracts for initial inclusion criteria. A full-text review of 30 studies was conducted. The authors included 19 studies in the systematic review and 5 studies were included in the meta-analysis. Both a fixed- and random-effects model (Q = .2321, I2 = 0%) yielded a medium-sized statistically non-significant association (r = 0.217) between skills and self-efficacy. Despite the small sample size, findings suggest that skills and self-efficacy may not be as interchangeable as previously assumed when assessing condom application. Implications for future research are discussed.