Skip to main content
OpenTrials
Completed

NCT Number: NCT03736876

A Healthy Relationships Program for Vulnerable Youth

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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy, Unplanned Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California School Based Health Alliance, Oakland, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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.

Treatment and study plan

About Us

Behavioral

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.

Primary outcomes

  1. Rates of vaginal or anal sex without condoms

    Time frame: 9 months post intervention

    Reported number of times having had vaginal or anal sex without using condoms or insertive condoms.

Secondary outcomes

  1. Rates of abstinence of vaginal or anal sex

    Time frame: 3 months post intervention

    Reported number of times having had vaginal or anal intercourse. Response options range from 1 "Never" and 5 "4 or more times".

  2. Rates of abstinence of vaginal or anal sex

    Time frame: 9 months post intervention

    Reported number of times having had vaginal or anal intercourse. Response options range from 1 "Never" to 5 "4 or more times".

  3. Frequency of communicating without abuse

    Time frame: 3 months post intervention

    Reported number of times communicating with a partner without abuse. Response options range from 1 "Never - this has never happened in your relationship" to 4 "Often: this has happened 6 times or more in your relationship".

  4. Frequency of communicating without abuse

    Time frame: 9 months post intervention

    Reported number of times communicating with a partner without abuse. Response options range from 1 "Never - this has never happened in your relationship" to 4 "Often: this has happened 6 times or more in your relationship".

  5. Clinic utilization

    Time frame: 3 months post intervention

    Number of times receiving services or information from school-based health center on contraception, pregnancy, abortion, or sexually transmitted diseases

  6. Clinic utilization

    Time frame: 9 months post intervention

    Number of times receiving services or information from school-based health center on contraception, pregnancy, abortion, or sexually transmitted diseases.

  7. Behavioral intentions to engage in sexual activity

    Time frame: 3 months post intervention

    4 items from the Sexual Behavior Index (SBI) that assess one's willingness and intention to engage in sex in the next 3 months. Response options range from 1-7 with lower scores indicating lower willingness or intentions to engage in sexual activity.

  8. Behavioral intentions to engage in sexual activity

    Time frame: 9 months post intervention

    4 items from the Sexual Behavior Index (SBI) that assess one's willingness and intention to engage in sex in the next 9 months. Response options range from 1-7 with lower scores indicating lower willingness or intentions to engage in sexual activity.

  9. Behavioral intentions to use condoms

    Time frame: 3 months post intervention

    Assessed using 3 items from the COMPAS Program Behavioral Intentions Scale designed to measure one's intentions to acquire, discuss, and use condoms before sex. Items response options range from 1-4 with higher scores indicating higher intentions to perform the health behavior.

  10. Behavioral intentions to use condoms

    Time frame: 9 months post intervention

    Assessed using 3 items from the COMPAS Program Behavioral Intentions Scale designed to measure one's intentions to acquire, discuss, and use condoms before sex. Items response options range from 1-4 with higher scores indicating higher intentions to perform the health behavior.

Sponsors and collaborators

Lead sponsor

ETR Associates

Other

Collaborators

  • California School-Based Health Alliance
  • Family and Youth Services Bureau
  • San Diego State University

Registry information

Official study title

About Us: A Healthy Relationships Program for Vulnerable Youth

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2018
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.