A Healthy Relationships Program for Vulnerable Youth
Completed · Not applicable
Conditions studied: Pregnancy, Unplanned, Sexually Transmitted Diseases
In brief
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?
Key facts
- Study ID
- NCT03736876
- Run by
- ETR Associates
- People needed
- 550
- Starts
- 2018-02-01
- Expected to finish
- 2021-05-12
- Last updated by the study team
- 2022-03-24
Who can join
Age: 14 and older, up to 18. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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:
- prior exposure to violence;
- 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.
You may not qualify if…
- 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.
Where it is running
- California School Based Health Alliance — Oakland, California, United States
- San Diego State University — San Diego, California, United States
- ETR — Scotts Valley, California, United States
Full record on ClinicalTrials.gov
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