Replication of Evidence-based Programs
Condition: Sexual Behavior
Study type: Interventional

Summary: 
      The purpose of this school-level randomized intervention trial is to evaluate the It's Your
      Game…Keep It Real program, an evidence-based teen pregnancy, HIV, and STI prevention program,
      among 2,000 students from 20 middle schools in 10 participating school districts in Harris
      County and surrounding areas. An audio computer-assisted self interview (A-CASI) assessment
      was used to assess demographic characteristics, psychosocial factors, sexual behaviors, and
      program exposure at three data collection points. Data was collected at baseline
      (preintervention), 6 months post intervention, and 12 months post intervention.
    

Detailed description: 
      Program Implemented: It's Your Game…Keep It Real (IYG) consists of 12 50-minute lessons
      delivered in 7th grade (8 in class and 4 via computer) and 12 50-minute lessons delivered in
      8th grade (7 in class and 5 via computer). The intervention was provided to the same 7th and
      8th graders over a two-year period (i.e., the same students receive up to 24 lessons over two
      years). The curriculum is grounded in social cognitive theory, the theory of triadic
      influence, and social influence models. The lessons were delivered according to the schedule
      that worked best for schools (for example, twice a week, once a week, or daily) within a
      school semester. The lessons were delivered by trained teachers during regular classroom time
      and were taught during a variety of subject areas (for example, physical education/health,
      social studies, and science). Teachers implementing the lessons were required to attend
      training in order to teach the 7th- and 8th-grade lessons.

      Sample: This sample included students at 20 schools from selected school districts throughout
      the greater Houston, Texas, area that agreed to participate in the study and that served 7th
      and 8th grades. Student inclusion criteria required that students not face language barriers
      or require educational accommodations that would preclude them from participation in the
      survey data collection process. Data collection staff, blind to school study condition,
      recruited 7th-grade students attending eligible classes across the 20 middle schools
      participating in the randomized controlled trial. A mix of census and sampling was used when
      securing consent for participation. In schools with 250 or fewer 7th-grade students, consents
      were distributed to all students. For schools with 7th-grade enrollments of more than 250,
      classes were sampled randomly and consents were distributed to 180 students. The study
      included one cohort and followed students from 7th through 9th grades. The final enrolled
      sample size was 2,588 students for whom parental consent and student assent were obtained.

      Setting: The study sites included 20 urban middle schools, in Harris County, Texas. The
      program was implemented in 10 intervention schools by trained facilitators. Most facilitators
      in both 7th and 8th grades were physical education teachers.

      Data Collection: Data was collected at baseline (preintervention), 6 months post
      intervention, and 12 months post intervention.

      Data Analysis: Impact data were analyzed using multilevel regression due to the nested nature
      of the study design (students within schools).
    

Intervention name(s): It's Your Game...Keep it Real
Intervention type(s): Behavioral
Intervention description(s): It's Your Game...Keep it Real consists of 12 50-minute lessons delivered in 7th grade (8 in class and 4 via computer) and 12 50-minute lessons delivered in 8th grade (7 in class and 5 via computer). In each grade, the curriculum integrates group-based classroom activities with personalized journaling and individually tailored computer-based activities. A life-skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal rules regarding risk behaviors, detect signs or situations that might challenge these rules, and use refusal skills and other tactics to protect these rules. The curriculum is grounded in social cognitive theory, the theory of triadic influence, and social influence models.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention