A game-based intervention for adolescent pregnancy prevention: Protocol for a multi-site randomized controlled trial evaluation.

BACKGROUND: Existing adolescent pregnancy prevention programs have demonstrated modest effects. Evaluation is needed for interventions aimed at improving intermediary outcomes linked to behaviors associated with adolescent pregnancy prevention, including intentions, communication skills, decision-making skills, access to information, and supportive adult relationships. These intermediary outcomes often serve as mechanisms that decrease sexual behaviors associated with unintended pregnancy and sexually transmitted infection risk and enhance understanding of how interventions influence behavior. The United States federal government announced a funding cycle aimed at assessing innovative programs for underserved youth. As one of the 12 grantees, we will evaluate Using the Connect (UTC), a novel game-based learning intervention offering opportunities to improve participants' intention to delay sex, skills related to communication, decision-making, and accessing information, and strengthen their connection to a trusted adult. OBJECTIVE: Our article describes the clustered randomized controlled trial protocol to assess the effectiveness of UTC on middle-school youths' intention to delay sex, individual-level skills (communication, decision-making, and accessing information), and perception of connection to a trusted adult. METHODS: This multi-site trial had planned enrollment for 1,150 youth ages 10-14 years from 46 community-based organizations in Texas, Alabama, and Illinois. Sites will be randomized to either UTC or business-as-usual control consisting of routine youth programming (e.g., physical activity, career education, and mental health awareness). UTC consists of four interactive games, one wrap-up activity, and one take-home activity focused on communication, decision-making, accessing sexual health information and resources, and strengthening connections with trusted adults. Participants will complete electronic surveys at baseline, immediate post-test, 3-month follow-up, and 9-month follow-up. Outcomes will be assessed using adapted survey measures of intention to delay sexual intercourse, communication skills, decision-making skills, skills to access sexual health information and resources, and perceived connection to trusted adults. To decrease attrition, we will use an evidence-based retention model. We will conduct sensitivity analyses to assess the robustness of findings. RESULTS: Funding was received in September 2021 through the Personal Responsibility Education Innovative Strategies (PREIS) funding opportunity within the Personal Responsibility Education Program of the Department of Health and Human Services. Site recruitment and enrollment began in June 2023. Between June 15, 2023, and May 31, 2025, 1,338 youth have been enrolled in the study. Follow-up data collection was completed in April 2026. As of July 2026, all study activities have concluded, and data from 1,231 participants were included in the final analysis, which is being completed. The final evaluation report will be submitted by September 2026. Findings will be disseminated through scientific conferences and peer-reviewed publications. CONCLUSIONS: This study will evaluate and contribute evidence regarding a novel, game-based intervention to strengthen protective factors associated with adolescent pregnancy prevention in middle school-aged youth. CLINICALTRIAL: This trial was registered at ClinicalTrials.gov (NCT05927194) on June 6, 2023.