A Healthy Relationships Program for Vulnerable Youth

Sexually Transmitted Diseases Clinical Trial

Official title:

About Us: A Healthy Relationships Program for Vulnerable Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736876
• Other study ID #: 90 AP2682-01-00
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: May 12, 2021

Study information

• Verified date: March 2022
• Source: ETR Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: May 12, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy, Unplanned
• Sexually Transmitted Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	California School Based Health Alliance	Oakland	California
United States	San Diego State University	San Diego	California
United States	ETR	Scotts Valley	California

Sponsors (4)

Lead Sponsor	Collaborator
ETR Associates	California School-Based Health Alliance, Family and Youth Services Bureau, San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of vaginal or anal sex without condoms	Reported number of times having had vaginal or anal sex without using condoms or insertive condoms.	9 months post intervention
Secondary	Rates of abstinence of vaginal or anal sex	Reported number of times having had vaginal or anal intercourse. Response options range from 1 "Never" and 5 "4 or more times".	3 months post intervention
Secondary	Rates of abstinence of vaginal or anal sex	Reported number of times having had vaginal or anal intercourse. Response options range from 1 "Never" to 5 "4 or more times".	9 months post intervention
Secondary	Frequency of communicating without abuse	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".	3 months post intervention
Secondary	Frequency of communicating without abuse	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".	9 months post intervention
Secondary	Clinic utilization	Number of times receiving services or information from school-based health center on contraception, pregnancy, abortion, or sexually transmitted diseases	3 months post intervention
Secondary	Clinic utilization	Number of times receiving services or information from school-based health center on contraception, pregnancy, abortion, or sexually transmitted diseases.	9 months post intervention
Secondary	Behavioral intentions to engage in sexual activity	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.	3 months post intervention
Secondary	Behavioral intentions to engage in sexual activity	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 months post intervention
Secondary	Behavioral intentions to use condoms	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.	3 months post intervention
Secondary	Behavioral intentions to use condoms	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.	9 months post intervention