A Healthy Relationships Program for Vulnerable Youth

NCT03736876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2022-03-24

No results posted yet for this study

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?

Conditions

  • Pregnancy, Unplanned
  • Sexually Transmitted Diseases

Interventions

BEHAVIORAL

About Us

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.

Sponsors & Collaborators

  • Family and Youth Services Bureau

    collaborator UNKNOWN
  • San Diego State University

    collaborator OTHER
  • California School-Based Health Alliance

    collaborator OTHER
  • ETR Associates

    lead OTHER

Principal Investigators

  • Karin K Coyle, PhD · ETR

  • Pamela M Anderson, PhD · ETR

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2021-05-11
Completion
2021-05-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03736876 on ClinicalTrials.gov