A Healthy Relationships Program for Vulnerable Youth
Condition: Pregnancy, Unplanned; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      Developed from a piloted intervention and based on scientific evidence, About Us is an
      innovative healthy relationships intervention that promotes positive adolescent romantic
      relationships and use of condoms and highly effective contraceptives if having sex. The
      program includes 10 lessons (2 that are between 30-45 minutes long 8 that are 50 minutes
      long) that blend group-based activities with online activities implemented in a small group
      format with students in grades 9 or 10 who have parental consent and provide assent to take
      part. The program will be implemented in school-based health centers (SBHCs).

      Primary research question:

        1. Nine months following the end of the program, what is the impact of About Us relative to
           the standard of care on:

           1.1. Rates of vaginal or anal sex without condoms in the past three months?

           Secondary research questions:

        2. Three and nine months following the end of the program, what is the impact of About Us
           relative to the standard of care on:

           2.1. Rates of abstinence from vaginal or anal sex in the past three months? 2.2.
           Frequency of communicating without abuse? 2.3. Utilization of school-based health center
           services? 2.4. Rates of behavioral willingness and attitudes toward birth control?

           Exploratory research questions:

        3. Three and nine months following the end of the program, what is the impact of About Us
           relative to the standard of care on:

           3.1. The psychosocial variables stemming from the theoretical framework (e.g., attitudes
           toward condom and contraceptive use, normative beliefs, perceived self-efficacy to use
           condoms or have difficult conversations) and enumerated in the logic model.

           3.2. Outcomes listed above within key sub-groups including those defined by sex
           (male/female), race/ethnicity, and exposure to violence;

        4. Among those receiving About Us, how do effect sizes for the primary and secondary
           behavioral outcomes vary by dosage?
    

Detailed description: 
      Students will be screened for eligibility through each school-based health center (SBHC) by
      SBHC staff, and those participants meeting the screening eligibility requirements (previous
      exposure to violence and/or previous or current involvement in a romantic relationship) will
      be offered a parental consent form and informational packet. Consent forms will be available
      in English and Spanish. Pending parental consent and youth assent, students will be
      randomized into either the intervention or control group.
    

Intervention name(s): About Us
Intervention type(s): Behavioral
Intervention description(s): Each program session includes an initial soap opera-like story to build interest and illustrate key concepts, 2-3 group-based activities with reflection, individual app-based work on tablets to allow for personalization of the content, and a group-based debrief to reflect on the day and reinforce key messages. The group-based content is delivered by trained facilitators from the participating school-based health centers. The app-based content is housed on a secure website and accessed through tablets with unique log-ins for each participant. Activities are completed individually during the session (e.g., completing a poll; watching and responding to a brief video). Several lessons include homework activities that encourage communication between students and a caring adult.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-site independent randomized group treatment trial (IGRT). 1,209 youth randomized to intervention or control conditions within schools. Sample accrues over 2.5 years (Years 2-4)
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Youth; Adolescents; Teens; Healthy Relationships; Unintended Pregnancy; Teen Pregnancy; Sexually Transmitted Infections; Sexually Transmitted Diseases; Sexual Health Education; School-Based Health Center; Randomized Controlled Trial