Using the Connect: Game Based Intervention

Contraception Clinical Trial

— UTC  

Official title:

Evaluation of Using the Connect: A Game-Based Intervention for Adolescent Pregnancy Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927194
• Other study ID #: 2022-0471
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: June 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Brittany Rosen, PhD, MeD
• Phone: 5138032911
• Email: brittany.rosen[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Contraception
• Health Behavior

Intervention

Behavioral:
• Using the Connect
Using the Connect (UTC) is an innovative, game-based intervention for youth to develop skills in adulthood preparation topics such as communication, decision making and accessing information.

Locations

Country	Name	City	State
United States	HYPE	Bryan	Texas
United States	Southwest Border AHEC	Eagle Pass	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in youth's intention to delay sexual intercourse before Using the Connect to 3 months post Using the Connect via self-reported questionnaire.	How does UTC impact youth's intention to delay sexual intercourse, compared to youth who have not received UTC at 3-month follow-up?	3-months