Using the Connect: Game Based Intervention

NCT05927194 | Enrolling By Invitation

• 1 other identifier: 2022-0471
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Behavior; Contraception; Health Behavior

Keywords

Adolescent Pregnancy Prevention; Sexual Health Education

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Using the Connect

EXPERIMENTAL

Using The Connect (UTC) is a game-based learning program designed for middle school-aged youth (ages 9-15 or grades 6-8) consisting of four games played in a facilitated environment, and one take-away activity. The goals of the program include:To be a vehicle that encourages community sharing of healthy teen behavior. To facilitate safe connections between youth and adults in their community. To empower youth to lead healthy sexual lives. The four games each focus on specific health content or skills including growth and development, accessing information, positive communication, and decision-making. Each of the four games is intended to be played for a total of 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.

Behavioral: Using the Connect

Business as Usual

NO INTERVENTION

Participants will not receive the Using the Connect curriculum.

Interventions

Using the Connect BEHAVIORAL

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.

Using the Connect

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Unable to read and speak in English

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Texas A&M University: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Adolescent Behavior; Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Brittany Rosen, PhD, MEd

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 3, 2023
• Study Start: June 15, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 20, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)