Clinical trial NCT05927194: Using the Connect: Game Based Intervention
Official title: Evaluation of Using the Connect: A Game-Based Intervention for Adolescent Pregnancy Prevention
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Adolescent Behavior
Contraception
Health Behavior
Keywords: Adolescent Pregnancy Prevention
Sexual Health Education
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Texas A&M University
First posted: 2023-07-03
Enrollment: 1400
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aims to implement Using the Connect (UTC), an innovative, game-based intervention designed to increase protective factors and decrease adolescent pregnancies. This intervention will be implemented in Texas middle schools and community-based organizations. The long-term goal is to promote optimal health in youth and prevent adolescent pregnancy in populations disproportionately impacted by adolescent pregnancy and sexually transmitted infection (STI) rates. The short-term objective is to conduct a robust, multi-site clustered randomized controlled trial to evaluate implementation outcomes and the impact of UTC, a novel theory-based game developed using powerful and effective human-centered design (HCD) strategies, on intention to delay sexual activity.

Detailed description: Background: While the teen birth rate for the US is at a historic low of 16.7 per 1000 females, the state of Texas ranks 5th in teen pregnancies and 7th in teen births. The teen birth rate for the state of Texas is 22.4 per 1000 females.

Using the Connect (UTC) is an innovative, game-based intervention for youth designed by youth and community stakeholders to increase protective factors and decrease adolescent pregnancies. UTC enhances the learning environment and can be implemented in various settings including classrooms, after-school programs, community-based organizations, and with other youth age groups. Interventions developed by youth that are adaptable to meet community context and needs are lacking. UTC is a youth-developed intervention formatively tested with positive results and acceptability in areas of North Carolina and Texas. Specifically, the formative evaluations results showed that youth found the design of UTC highly acceptable, felt the games and content were engaging and relatable, and learned knowledge and skills around adolescent development, accessing information, communication, and making healthy decisions through playing the games. Youth participants reported that they would recommend the program to friends, would participate in the program again, and use the information they learned from the program in the future. The game-based program offers knowledge and skill development in adulthood preparation subjects including communication, decision making, and accessing information. In addition, the game is engaging and provides opportunities for peer interaction. This innovative intervention changes the environment that facilitators and youth are often presented in adolescent health programs and offers an interesting and unique opportunity for skill development and community building.

Purpose: The purpose of this study is to conduct a multi-site clustered randomized controlled trial to evaluate the impact of UTC, a novel theory-based game developed using powerful and effective human-centered design (HCD) strategies, on intention to delay sexual intercourse.

The primary research question:

1. How does UTC impact youth's intention to delay sexual intercourse, compared to youth who have not received UTC, at post-test and 3-month follow-up?

Methods: A multi-site clustered randomized controlled trial will be conducted to determine the effectiveness of UTC on primary outcomes. A combination of school sites and community-based organization sites will be recruited and randomized to serve as either a treatment or control group. Up to 1,800 participants will complete validated surveys at baseline (prior to participating in the treatment or control group) and immediate post (after participating in the treatment or control group), followed by 3-month, and 9-month follow-up surveys. The surveys will be approximately 30-minutes long.

Implications:

Primary Research Question:

1. How does UTC impact youth's intention to delay sexual intercourse, compared to youth who have not received UTC, at post-test and 3-month follow-up?

Eligibility criteria: Inclusion Criteria:

* Middle school-aged youth at one of the participating community-based organization or school sites in Texas
* Ability to complete Using the Connect in English
* Ability to read and complete surveys in English without assistance

Exclusion Criteria:

* Unable to read and speak in English

Primary outcomes:
measure: Change in youth's intention to delay sexual intercourse before Using the Connect to 3 months post Using the Connect via self-reported questionnaire.
timeFrame: 3-months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Brittany Rosen, PhD, MEd
role: PRINCIPAL_INVESTIGATOR
References: