For over 30 years, the US adolescent birth rate has been declining [1]. However, the United States ranks highest on the list of industrialized nations for rates of adolescent pregnancy and teen births [1-3]. Adolescent pregnancy and teen births are linked to adverse economic, health, and educational outcomes for both parents and children [4]. Specifically, teen parents are less likely to continue their education, which leads to a decrease in economic opportunities and a reduction in lifetime earnings, while their children are more likely to experience preterm birth and lower birth weight which is highly associated with adverse developmental and social outcomes [4,5]. Moreover, disparities in teen birth rates persist. The US teen birth rates among American Indian/Alaska Native, Native Hawaiian/Pacific Islander, Black, and Hispanic adolescents were twice the rate compared to White adolescents, with additional disparities occurring across geographic regions [6]. Texas has historically reported adolescent birth rates above the national average. In response, substantial federal and state investments have focused on adolescent pregnancy prevention programming targeted to youth populations at increased risk for unintended pregnancy. The adverse health, developmental, and economic outcomes and persistent disparities underscore the need for innovative, developmentally appropriate, and accessible pregnancy prevention interventions for adolescents.

To address the public health concern of adolescent pregnancy in the United States, most interventions have focused on individual-level factors, such as sexual health knowledge, attitudes, decision-making skills, and behaviors associated with adolescent pregnancy prevention [7-9]. Recent efforts in both the United States and internationally have begun recognizing that sexual health is influenced by interactions between knowledge, skills, social, and environmental factors [10,11]. Thereby, prevention programs are increasingly incorporating parent and community engagement and creating supportive environments [9,12,13]. However, maintaining adolescent engagement throughout such programming remains a challenge. This has increased interest in innovative intervention approaches providing opportunities for active and engaged learning for skill development [14,15].

Game-based learning (GBL) has the potential to be both engaging and educational [16,17]. While traditional games aim to entertain the user, GBL aims to educate the user through gameplay [18]. GBL is an effective strategy that is highly attractive and motivating for participants [19,20]. When designed appropriately, GBL participants are motivated, focused, and engaged to the point of repeated playing or returning to the game over time [19]. GBL cultivates critical thinking, motivates youth to apply knowledge and skills, and increases confidence levels more efficiently than traditional teaching methods [21,22]. According to GBL theoretical underpinnings, games can support education and skill development in communities with limited resources or social norms that discourage discussion of taboo topics, such as sexual health, and when developed collaboratively with community stakeholders, can also address sociocultural norms that may be overlooked in traditional programming [20]. Thus, GBL provides opportunities and situations to practice communication and decision-making skills, receive feedback, and learn about consequences in a safe, low-risk environment.

To develop a GBL intervention, we used the human-centered design (HCD) process to ensure the intervention reflected the needs, preferences, and experiences of the community. As a first step, a nonprofit community organization participated in an HCD “boot camp” led by the Innovative Teen Pregnancy Prevention Programs (iTP3) team [23]. During this boot camp, HCD strategies and brainstorming of ideas led to an innovative adolescent pregnancy prevention program idea for their community. After intensive activities to gain insights, a promising idea for a game emerged. To further develop their idea, the design team engaged in a design sprint completing HCD activities to iteratively develop program components. The design team shared their ideas and progress with youth and other community stakeholders for feedback and completed the design sprint with a prototype of Using the Connect (UTC), a novel, interactive game-based intervention consisting of 4 in-person stations and 1 take-home activity. By using skills practice, feedback, peer learning, and guided reflection, UTC aims to strengthen protective factors associated with adolescent pregnancy prevention by developing skills in communication, decision-making, and accessing information, as well as perception of connection with trusted adults. UTC was developed to provide a flexible intervention that can be implemented across varying community settings serving youth. For additional details regarding the intervention development process, see Esquivel et al [24].

The resulting intervention, UTC, was then grounded in the social cognitive theory (SCT), which states that changing a person’s behavior is a result of increasing intention by adjusting their self-efficacy, as well as their expectations and expectancies [25,26]. Specifically, our conceptual model centers on intention to delay sexual intercourse and to use condoms and contraceptives when sexually active, self-efficacy related to communication skills, decision-making skills, and skills to access sexual health information and resources, and expectations and expectancies related to making decisions for behaviors to prevent pregnancy and sexually transmitted infections (STIs). These SCT constructs were selected due to being identified in empirical studies as salient protective factors against adolescent pregnancy [27]. In addition, we also selected to include youth’s perception of connection to trusted adults in our conceptual model, as this construct has been shown to be associated with adolescents’ overall well-being [28].

As a next step, we aligned our conceptual model’s constructs with appropriate behavior change techniques (BCTs). BCTs are defined as intervention components and activities designed to modify the specific behavior or health outcome [29]. Examples of BCTs include feedback, instructions on how to perform behaviors, information about health consequences, and demonstration of the behavior [30]. Our selected BCTs were then operationalized and aligned with the intervention’s games and activities. The games and take-home activity were systematically organized and linked with the corresponding BCTs and conceptual model constructs to guide our rigorous impact evaluation.

UTC was formatively tested in North Carolina and Texas with positive results [24]. Specifically, the youth reported the design of UTC was highly acceptable, the games and content were engaging and relatable, and that they learned knowledge and skills around adolescent development, accessing information, communication, and making decisions related to pregnancy prevention. Youth stated they would recommend the program to friends, would participate in the program again, and use the information they learned in the future [24]. For additional details regarding the usability testing, see Esquivel et al [24].

Over the past decade, substantial US federal investments have strengthened the adolescent pregnancy prevention evidence base through the Teen Pregnancy Prevention (TPP), Personal Responsibility Education Program (PREP), and Personal Responsibility Education Program Innovative Strategies (PREIS) initiatives [31]. Collectively, these programs have supported the development, implementation, and rigorous evaluation of interventions designed to reduce adolescent pregnancy and associated sexual risk behaviors among diverse populations of youth. Lessons learned from these federally funded evaluations have highlighted the importance of testing innovative interventions, examining intermediary protective factors that may influence sexual health behaviors, and disseminating detailed evaluation protocols to support transparency, replication, and methodological rigor [32,33]. As a result, there remains a need for rigorous randomized trials that evaluate novel approaches to adolescent pregnancy prevention while clearly documenting intervention theory, implementation procedures, and evaluation methods [33,34].

As 1 of the 12 PREIS grantees evaluating an innovative intervention to decrease adolescent pregnancy prevention, we aim to describe—in detail—the evaluation protocol for a multisite, clustered randomized controlled trial (cRCT). Specifically, we developed a protocol and logic model (Figure 1) to test the impact of UTC on intermediary outcomes. Because most middle school–aged youth have not yet initiated sexual intercourse, behavioral outcomes are expected to demonstrate limited variability during the study period. Therefore, intention to delay sexual intercourse was selected as the primary outcome because it is developmentally appropriate for this population, theoretically aligned with the intervention’s conceptual model, and represents a proximal indicator of future pregnancy prevention behaviors [35]. Furthermore, because UTC centers on promoting skills in communication, decision-making, and accessing information and resources, increasing perception of connection to a trusted adult, and intentions to use condoms and contraception when sexually active, these constructs were included as additional outcomes in the conceptual model and evaluation and are hypothesized to influence intentions and behaviors associated with adolescent pregnancy prevention.

Identifying intermediate outcomes, with potential to serve as protective factors against pregnancy, aligns with the previous calls to action and specifies the first step in how the intervention produces its effect. This, in turn, allows us to apply the results for program improvement and future evaluations. In describing the protocol, we ensure the procedures from this project can be replicated with fidelity to test the intervention in varying settings and populations. Furthermore, this study adds to the methodological foundation to support future grantees in conducting and completing cRCTs. Such information will help overcome the context-dependent success of programs and decrease the resources spent on identifying the factors behind noneffect replication studies.

Thus, the overall aim of this study is to evaluate the effectiveness of UTC among middle school–aged youth. The objectives are to (1) assess the impact of UTC on youth’s intention to delay sexual intercourse, (2) assess the impact of UTC on communication skills, decision-making skills, and skills to access sexual health information and resources, and (3) assess the impact of UTC on youth’s perceived connection to trusted adults. Given that participation in the intervention is minimal-risk, no specific harms are anticipated; however, adverse events and unintended consequences will be monitored throughout the study. Our study describes the cRCT evaluation protocol to answer the following primary research questions:

This study is a prospective, 2-arm, multisite cRCT with data collection at multiple time points. Study arms include a control arm, in which participants will receive a business-as-usual program, and a treatment arm, in which participants will receive the UTC program. An overview of the trial’s specifications is presented in Table 1.

This project will have 2 core functions: UTC implementation and impact evaluation. Thus, this 2-prong approach will use a collaborative model with key leadership comprising of faculty and staff from Texas A&M University (TAMU) serving as the implementation team, and Cincinnati Children’s Hospital Medical Center (CCHMC) serving as the evaluation team. The leads for each team will meet monthly to discuss project status and timeline and address any anticipated challenges. The implementation team (TAMU) will facilitate all implementation activities which include UTC facilitator training, develop site-specific implementation plans, lead monthly conference calls with the full study team, collaborate with facilitators to codevelop the implementation database, provide ongoing technical assistance and support to UTC facilitators, and conduct the implementation evaluation. The evaluation team (CCHMC) will develop and implement all impact evaluation tools and the data collection protocol, provide and oversee data collection training to study sites, assist in collecting and reporting PREIS performance measures data, conduct data management and analyses, and develop and disseminate final evaluation report.

We will enroll and randomize 46 community-based organization (CBO) sites located in Texas, Alabama, and Illinois. Using their extensive professional network, the implementation team will identify, recruit, and enroll community-based sites. Strategies to identify sites will include contacting organizations in their professional network serving middle school youth, obtaining recommendations for potential partnering organizations from existing stakeholders, and recruiting at adolescent health conferences. The inclusion criteria for sites include CBOs serving youth aged 10-14 years or youth in 5th to 8th grade. Examples of CBO sites include, but are not limited to, youth development organizations, religious organizations, and after school programs. To participate, eligible sites will (1) be randomized to the treatment or control group, (2) allow youth to complete baseline and immediate follow-up surveys at the site, and (3) allow for study activities, including recruitment, enrollment and consenting procedures, to occur at the site. If the site is eligible, evaluation staff will meet with the site to explain study procedures and expectations. Participating sites will be enrolled in the study. When sites agree to participate, they will complete three steps prior to being randomized: (1) review and sign a memorandum of understanding outlining the study procedures and expectations for recruiting and collecting data from a minimum of 30 youth, (2) participate in study protocol training for recruitment, enrollment, and data collection, and (3) coordinate with the evaluation team to identify dates for youth recruitment, enrollment, and baseline data collection. Once these steps are completed, our randomization procedures will be followed to randomize the site to a study arm. If sites have additional capacity to reach and recruit >30 youth, the implementation team will set a realistic goal in collaboration with the sites to align with project resources and available support.

Immediately after enrollment, sites will be randomized in a 1:1 block allocation to either the treatment or control group using a computer-generated randomization schedule to assign a study arm to each site. Given the distinct curriculum differences in programs for each arm, randomization cannot be blinded to the study teams, program facilitators, or participants. However, our statistician will be blinded prior to analysis.

Site facilitators will implement the program and on-site evaluation activities. Eligibility to serve as a site facilitator includes any staff member from a participating CBO or a TAMU implementation staff member. Site facilitators will not be recruited for the study. Instead, participating sites will identify staff members to facilitate UTC as part of their agreement to participate in the study. Site facilitators are not required to hold any particular background or qualifications to be eligible to deliver the intervention, due to the game-based design of the intervention.

The implementation team will train facilitators to successfully implement the UTC program. Implementation training will consist of a 6-hour in-person training course for each site. The training is for any individual at the site who will facilitate UTC. The training will include information on the program’s background as well as provide an opportunity to play the 4 games, the wrap-up activity, and the take-home activity. By having the site facilitators play the games during the training, the implementation team can answer facilitators’ questions as they arise during gameplay. To complete the training, the implementation team will debrief by providing information regarding best practices in the learning environment, ensuring facilitators understand mandatory reporting laws, and allowing time for questions from facilitators.

The evaluation team will train facilitators to successfully complete on-site evaluation responsibilities and activities, including distributing study information sheets to parents, study enrollment, group assent, survey facilitation, ethical research practices, and connecting participants with the study team, as needed. The evaluation training will include a training packet, which requires facilitators to review a site manual introducing the study objectives as well as processes and activities they will be responsible for implementing. Facilitators are expected to use the manual as a reference to the procedures throughout the study duration. After reviewing the manual, the facilitators will complete the required online research training course titled Community Involvement in Research Training (CIRTification). Provided by the University of Cincinnati’s Center for Clinical and Translational Science and Training (CCTST) at no cost, CIRTification is a human research protections training created for community research partners [37]. After completing the CIRTification, facilitators will review 2 training videos. The first training video reviews the study objectives, activities, and responsibilities of the facilitator. The second training video guides the facilitators through using the assent and enrollment scripts provided in the training packet, for conducting the assent and enrollment procedures. During the video, facilitators can pause and practice each component of the assent and enrollment process. Facilitators can rewatch the video at any time during the study. As a last step, facilitators are required to submit regulatory documents, including facilitators’ signed resumes and signed study delegation of authority log, to the evaluation team. After these documents have been submitted, a final meeting between the facilitators and evaluation team will be scheduled to review the training packet and answer any questions. Only after the final meeting will the facilitators receive the final study documents to officially begin recruitment and enrollment.

In addition to the comprehensive training, the evaluation team will use supplemental strategies to support and ensure facilitator success. Strategies include providing facilitators with a 1-page checklist outlining study activities and weekly office hours for facilitators to consult with the evaluation team. The weekly office hours will be a virtual standing meeting. The evaluation team will attend these weekly virtual meetings allowing any facilitators to attend the meeting with emergent questions or concerns.

All English-speaking youth between the ages of 10 and 14 years (5th-8th grade) receiving services at a participating site during the enrollment period (June 2023-June 2025) are eligible. Because UTC is an English-based program, participants must have the ability to complete the program and surveys in English without assistance.

Facilitators will use methods provided in the training to recruit eligible youth to participate in the program and evaluation activities. During the recruitment and enrollment process, facilitators will provide parents/caregivers with an institutional review board–approved study information sheet. The study information sheet provides contact information for the study team, explains the purpose of the study, the study activities and study payments, as well as any risks involved with survey data collection. Parents/caregivers can withdraw their child from the study at any time by contacting the evaluation team. Youth will use their personal or site provided devices to access and complete the eligibility screening, assent, and contact information form. Facilitators will initiate a group assent process in which eligible participants will be assented together. After completing the eligibility screening form, the assent form will open on youth’s devices. The facilitators will use a script designed by the evaluation team to guide youth through their assent forms. Youth who want to participate in the study will sign and complete the assent form on their device. Facilitators will complete an informed consent process note that will be sent to the evaluation team confirming the group assent procedures were followed. Figure 2 provides a consort diagram of the study flow.

UTC is a game-based intervention with an adaptable structure consisting of 4 stations played in-person and a wrap-up activity at a facilitated environment, and 1 take-home activity. Unique to UTC, games do not have to be played in a specific sequence, they do not have to be completed before playing a new game, nor are they constrained to be completed within a specific time frame. For this evaluation, each game will be “played” for at least 90 minutes, split up into sessions of 30 minutes per game. When combining all gameplay sessions, along with the instructions for the take-away activity and program wrap-up activity, organizations will dedicate approximately 8 hours to the program. The facilitator can alter which games are played during each session to keep youth engaged and prevent burnout. This process will continue until each game is played to completion.

UTC consists of 4 interactive games, 1 warp-up activity, and 1 take-home activity that collectively targets the knowledge, skills, and social supports identified in the conceptual model. Specifically, The Sum of the Parts focuses on adolescent development through trivia-style activities addressing physical, emotional, and social changes; Tapped In teaches youth how to identify and access credible sources of health information; More Than Words provides opportunities to recognize and practice effective communication skills through interactive scenarios; and Stop-Think-Act engages youth in structured problem-solving and decision-making exercises using realistic situations. The take-home activity, Making Connections, encourages youth to initiate conversations with trusted adults and strengthen supportive adult relationships. Across activities, youth are provided opportunities to practice skills, receive feedback, discuss consequences of decisions, and engage in peer learning within a facilitated environment. Table 2 provides a description of each game and activity.

Depending on the number of youth, staff, and space available, a site can have multiple groups playing different games or multiple groups playing the same game (at different tables) simultaneously. The intervention can be facilitated over the course of 2 days or up to 10 weeks depending on the setting and the participants’ needs.

UTC fidelity will be enhanced through standardized facilitator training and ongoing technical assistance by the implementation team. Fidelity will be tracked using facilitator logs developed by the implementation team. The facilitator log consisted of session date, minutes/hours the session lasted, location of the session, which games were played during the session, notes about the quality of the session (activities went well or did not go well), and notes on youth engagement after each event to capture implementation logistics and “real-time” notes.

Youth in the control group received “business-as-usual” for each corresponding control organization, which consisted of a broad range of health-related topics, including physical activity, career education, academic enrichment, mental health awareness, and awareness of community resources. The purpose of this trial is to evaluate UTC as a complete intervention package compared with programming routinely available in community settings. The study was not designed to isolate the independent effects of game-based delivery from intervention content. The “business-as-usual” control did not include the GBL activities or associated skill-building exercises incorporated within UTC.

An EFA will be conducted to assess each respective scale and subscale survey items for convergent and construct validity. Variables will be retained in a scale if the pattern/structure coefficient was greater than |0.4|. The scale selected in the EFA will be assessed to ensure the factor analysis has identified a cohesive scale identifying a single underlying construct. Cronbach α will be calculated. Based on the EFA results, a mean of all retained items will be calculated.

Multiple retention tools will be sent to participants to increase engagement, including personalized birthday cards with reminders of the next study activity, stickers with the study logo, and magnets with the study contact information. To minimize adolescent participant attrition, we will also implement an evidence-based retention model, the engagement, verification, maintenance, and confirmation (EVMC) protocol [61]. The EVMC protocol provides a stepwise process to reach participants regardless of mobility rates, quickly detect inaccurate contact information, and create multiple avenues to relocate participants [62]. For engagement, participants will complete a contact information form immediately after enrolling in the study. The form will collect participants’ cell phone numbers, email addresses, and mailing addresses, as well as ask participants to provide the email address, phone number, and mailing address of a trusted adult. Next, verification will be used on an “as needed” basis by contacting trusted adults to verify participant contact information if a participant is not completing survey activities. For the maintenance phase, we will send messages each month to participants with cell phones and email addresses reminding them when the next study activity will occur. We will also ask participants to confirm their contact information within the same monthly text and email messages used in the maintenance phase.

REDCap [38,39] will be used to complete and store data related to research activities including eligibility screening, assent forms, contact information, surveys and responses, and text and email reminders sent to participants. REDCap is a secure web-based data management platform designed exclusively to provide an intuitive interface for data capture in 21 Code of Federal Regulations Part 22, Federal Information Security Act, and Health Insurance Portability and Accountability Act–compliant environments. By using REDCap, we assure procedures for obtaining consent, data collection, and storage address confidentiality and privacy matters for study data and information collected. The REDCap system is housed in the CCHMC Information Services for Research (IS4R) on premises server system, which provides both physical and network security. Access to this system is limited to authorized staff only, with credentials maintained by CCHMC. Individual computer systems used by the evaluation team comply with CCHMC standards for device encryption and security. Within the REDCap system, each participant will be assigned a unique study ID and contact information will be stored in a REDCap form separate from their survey responses. Links between individual-level data and participant study IDs will be destroyed once the study is completed. The deidentified data will be stored on the IS4R server system. Per the data sharing agreement between the implementation and evaluation teams, CCHMC will provide TAMU appropriate scientific data and any additional metadata. A releasable quantitative database will be produced and completely deidentified in accordance with the data-sharing agreement prior to data sharing with TAMU. The database will not contain any site or participant identifiers. The evaluation team will develop a data dictionary consisting of all data elements and their definitions.

Because the behavioral intervention and study activities meet the requirements for minimal risk, we will monitor adverse events and will report events to the evaluation team’s institutional review board consistent with Cincinnati Children’s Research Foundation policy. The principal investigator (BR) will be responsible for participant safety and monitoring. All site facilitators will be trained in reporting all adverse events to the principal investigators or designated research coordinators. Participants will also be encouraged to contact the evaluation team with any questions or concerns and will receive the team’s contact information (study email and phone number) at enrollment. No interim analyses or formal stopping guidelines were planned due to the minimal risk nature of the behavioral intervention.

Ethics approval for this study was obtained from the CCHMC Institutional Review Board (IRB #2022-0471). A waiver of parental permission was requested and approved for this study. This is a minimal risk study and the waiver of parental consent will reduce bias in the enrollment of the study participants and has been granted for similar studies. Parents will be informed of the research through the study information sheet; however, due to the design of the program there is not a natural way for parents to provide parental permission nor to complete the informed consent process. All participants provided informed assent before enrollment. All study activities were optional, and participants were informed of their ability to opt out at any time. Access to participant data was restricted to authorized study personnel only and maintained with REDCap, secure web-based data management platform. A deidentified dataset was created prior to analysis to protect confidentiality and privacy of all participants. Participants received study compensation in the form of digital payments or gift cards for each completed study survey, not exceeding US $100 total for full study completion. These payment structures are set in accordance with CCHMC compensation guidelines and policies for human subjects research with minors.