Adolescent BehaviorUTCNCT05927194
Using the Connect: Game Based Intervention
A study testing Using the Connect in people with Adolescent Behavior and Contraception, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 15 years
- Conditions the study is for
- Adolescent Behavior, Contraception, Health Behavior
- What is being tested?
- Using the Connect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Unable to read and speak in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Evaluation of Using the Connect: A Game-Based Intervention for Adolescent Pregnancy Prevention
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.
Read the 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:
- 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:
- 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?
- Conditions
- Adolescent Behavior, Contraception, Health Behavior
- Being tested
- Using the Connect
- Keywords
- Adolescent Pregnancy Prevention, Sexual Health Education
- Medical subject headings
- Adolescent Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using the ConnectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Using the Connect |
| Business as Usual | No intervention | Participants will not receive the Using the Connect curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start15 Jun 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Texas A&M University
- Responsible party
- Principal investigator, Brittany Rosen, Children's Hospital Medical Center, Cincinnati
- Investigators
- Brittany Rosen, PhD, MEd, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927194
- Sponsor's protocol ID
- 2022-0471
- Acronym
- UTC
- Status last verified
- Aug 2024
- First submitted
- 6 Jun 2023
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosen B, Hineline S, Meisman A, Zhang B, Holden C, Esquivel C, Garney W, Wilson K. A game-based intervention for adolescent pregnancy prevention: Protocol for a multi-site randomized controlled trial evaluation. JMIR Res Protoc. 2026 Sep 4. doi: 10.2196/88047. Online ahead of print.
PubMed 42743434
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Using the Connect: A Game-Based Intervention for Adolescent Pregnancy Prevention
- ClinicalTrials.gov ID
- NCT05927194
- Acronym / sponsor ID
- UTC / 2022-0471
- Conditions
- Adolescent Behavior, Contraception, Health Behavior
- Keywords
- Adolescent Pregnancy Prevention, Sexual Health Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Texas A&M University
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using the Connect | Experimental | Behavioral: Using the ConnectUsing 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. |
| Business as Usual | No intervention | –Participants will not receive the Using the Connect curriculum. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to read and speak in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using the ConnectUsing 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. | Behavioural | Using the Connect |
Primary outcome
Change in youth's intention to delay sexual intercourse before Using the Connect to 3 months post Using the Connect via self-reported questionnaire.
Time frame: 3-months
How does UTC impact youth's intention to delay sexual intercourse, compared to youth who have not received UTC at 3-month follow-up?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Derived from this study: PubMed 42743434Rosen B, Hineline S, Meisman A, Zhang B, Holden C, Esquivel C, Garney W, Wilson K. A game-based intervention for adolescent pregnancy prevention: Protocol for a multi-site randomized controlled trial evaluation. JMIR Res Protoc. 2026 Sep 4. doi: 10.2196/88047. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Adolescent Behavior
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Not yet recruiting
Enlace Familiar: Supporting the Mental Health of Latino Adolescents
Mental Health
Not yet recruiting
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
Binge Eating, Overweight and Obesity
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittany Rosen, PhD, MEd principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using the Connect in people with Adolescent Behavior and Contraception, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05927194, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.