A Healthy Relationships Program for Vulnerable Youth

ETR Associates

Status: Completed

Conditions: Sexually Transmitted Diseases; Pregnancy, Unplanned

Treatments: Behavioral: About Us

Study type: Interventional

Funder types: Other

Identifiers

NCT03736876

90 AP2682-01-00

Details and patient eligibility

About

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?

Full 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.

Enrollment: 550 patients

Sex: All

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The target population includes 9th or 10th grade students from participating schools who meet at least one of the following inclusion criteria based on their responses to a school-wide health assessment:

  1. prior exposure to violence;
  2. prior or current experience with a romantic relationship.

Any student answering "yes" to either criteria would be eligible to take part in the study. Only those who have parent consent and assent would be enrolled.

Exclusion criteria

• Those students without parental consent;
• If siblings are eligible to participate, the sibling who returns the signed consent form first will be admitted into the study. Any other eligible siblings will be excluded.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

Treatment group

Experimental group

Description:

These students will receive About Us, an innovative, healthy relationship intervention. The program includes 10 lessons that blend group-based activities with online activities implemented in school-based health centers.

Treatment:

Behavioral: About Us

Delayed intervention (control group)

No Intervention group

Description:

These students will receive the business-as--usual condition (e.g., the standard health education that is provided by the school during the study period), and will receive the intervention once the study period has concluded.