The goal of this 3 year Fast-Track STTR is to develop and evaluate a home-based intervention ('it's Your Game- Family') to provide age-appropriate sexual health life skills education and training for children (11-14 years) and to enhance parents' skills and self-confidence in support of this training. IYG-Family (IYG-F) will be an on-line game- based program and resource available to help parents and their children go beyond "the sex talk" to engage in an ongoing, developmentally appropriate, pregnancy, sexually transmitted infection (STI), and human immunodeficiency virus (HIV) prevention education experience. The study comprises 2 phases and 10 specific aims: Phase 1: Develop the theoretically- and empirically-based IYG-Family (IYG-F) prototype and conduct usability and feasibility testing (Months 1-12). Phase 1 Specific Aims: 1.1 Conduct focus groups, acceptability tests with our Parent-Youth Advisory Group (P-YAG) and literature review to inform IYG-F design;1.2 Develop IYG-F design documents and program the prototype;1.3 Test the IYG-F prototype functions and content (alpha test), and usability;1.4 Evaluate (pilot-test) the IYG-F prototype fo feasibility and perceived value in the home setting;1.5 Disseminate Phase 1 findings: Phase 1 report and peer reviewed publications. Phase 2: Develop IYG-Family informed from Phase 1 data and conduct a RCT to evaluate the impact of IYG-F (Months 13-36). Phase 2 Specific Aims: 2.1 Revise IYG-F design documents (based on Phase 1 data) and obtain P-YAG sign-off;2.2 Develop the full IYG-F program;2.3 Test the IYG-F prototype functions and content (alpha test), and usability;2.4 Conduct a randomized controlled trial of IYG-F in 80 homes to test the 4 primary hypotheses (below);2.5 Disseminate Phase 2 findings: Phase 2 report and peer reviewed publications. The 4 primary hypotheses are 1. Compared to those not receiving IYG-F, youth who access IYG-F will demonstrate significantly greater intentions to abstain from initiation of sexual behavior. 2. Compared to those not receiving IYG-F, youth who access IYG-F will demonstrate significantly improved psychosocial determinants of sexual behavior (including knowledge, increased self-efficacy for refusing sexual activity;less permissive beliefs and perceived norms). 3. Compared to parents not accessing IYG-F, parents who access IYG-F will report significantly improved psychosocial determinants (including knowledge, attitudes, and self-efficacy) regarding parent-child sexual health communication and parental monitoring and less permissive beliefs related to youth sexual behavior. 4. Compared to youth and parents not receiving IYG-F, youth and parents who access IYG-F will report increased communication about sexual health, increased parental monitoring, increased parent-child connectedness, and improved parenting ratings. This project is founded on previous studies by this experienced collaborative investigative team on developing and testing a successful middle school pregnancy, STI, and HIV prevention program, It's Your Game...Keep it Real, (IYG) that addresses knowledge, attitudes, perceived norms, refusal, and communication skills related to healthy relationships, dating, and sex. Results from two randomized controlled trials conducted in Texas middle schools indicate positive psychosocial outcomes after 7th and 8th grade interventions, and significant, sustained behavioral outcomes to 9th grade. IYG-Family will include the successful skill building components of this curriculum but will be developed to also focus on parent-child communication and connectedness regarding sexual health in the home environment. IYG-Family is significant because it addresses the gap between the needs of families in preparing their sexually maturing youth and the developmentally appropriate intervention resources currently available to support them. It addresses the broader public health concerns of adolescent pregnancy, and STI and HIV infection. IYG-Family is innovative in providing a unique home-based resource for a challenge faced by every family with sexually maturing youth. In addition to providing developmentally appropriate sexual health education for the middle school child IYG-Family is positioned to contribute a solution for the discomfort and uncertainty of parents who lack confidence or skills to adequately provide effective information and skills training to help their child make healthy and responsible decisions about healthy friendships, dating relationships, and sex. It contributes a solution that is cost-effective, of hih-fidelity, and readily accessible.

Public Health Relevance

Despite steady decline in the United States over the past decade, adolescent births and sexually transmitted infections (STIs) remain serious public health issues. Teen pregnancy costs US taxpayers over $9 billion.4 One in four females (14-19 years) are infected with an STI5 and youth (15- 24 years) account for 9.1 million (48%) of all new STI cases, 6 with estimated medical costs of $6.5 billion.7 This study will contribute to our understanding of using the Internet to deliver an HIV/STI and pregnancy prevention program to middle school-aged students in home and mediated by parent involvement.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Business Technology Transfer (STTR) Grants - Phase II (R42)
Project #
4R42HD074324-02
Application #
8711827
Study Section
Special Emphasis Panel (ZRG1-RPHB-C (10))
Program Officer
Newcomer, Susan
Project Start
2012-09-20
Project End
2015-08-31
Budget Start
2013-09-13
Budget End
2014-08-31
Support Year
2
Fiscal Year
2013
Total Cost
$772,203
Indirect Cost
Name
Radiant Creative Group, LLC
Department
Type
DUNS #
113878909
City
Houston
State
TX
Country
United States
Zip Code
77018