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A Healthy Relationships Program for Vulnerable Youth

Primary Purpose

Pregnancy, Unplanned, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
About Us
Sponsored by
ETR Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy, Unplanned focused on measuring Youth, Adolescents, Teens, Healthy Relationships, Unintended Pregnancy, Teen Pregnancy, Sexually Transmitted Infections, Sexually Transmitted Diseases, Sexual Health Education, School-Based Health Center, Randomized Controlled Trial

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

  • California School Based Health Alliance
  • San Diego State University
  • ETR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

Delayed intervention (control group)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2018
Last Updated
March 22, 2022
Sponsor
ETR Associates
Collaborators
Family and Youth Services Bureau, San Diego State University, California School-Based Health Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT03736876
Brief Title
A Healthy Relationships Program for Vulnerable Youth
Official Title
About Us: A Healthy Relationships Program for Vulnerable Youth
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
May 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ETR Associates
Collaborators
Family and Youth Services Bureau, San Diego State University, California School-Based Health Alliance

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: 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: 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: 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; Among those receiving About Us, how do effect sizes for the primary and secondary behavioral outcomes vary by dosage?
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Unplanned, Sexually Transmitted Diseases
Keywords
Youth, Adolescents, Teens, Healthy Relationships, Unintended Pregnancy, Teen Pregnancy, Sexually Transmitted Infections, Sexually Transmitted Diseases, Sexual Health Education, School-Based Health Center, Randomized Controlled Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multi-site independent randomized group treatment trial (IGRT). 1,209 youth randomized to intervention or control conditions within schools. Sample accrues over 2.5 years (Years 2-4)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm 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.
Arm Title
Delayed intervention (control group)
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
About Us
Intervention Description
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 Outcome Measure Information:
Title
Rates of vaginal or anal sex without condoms
Description
Reported number of times having had vaginal or anal sex without using condoms or insertive condoms.
Time Frame
9 months post intervention
Secondary Outcome Measure Information:
Title
Rates of abstinence of vaginal or anal sex
Description
Reported number of times having had vaginal or anal intercourse. Response options range from 1 "Never" and 5 "4 or more times".
Time Frame
3 months post intervention
Title
Rates of abstinence of vaginal or anal sex
Description
Reported number of times having had vaginal or anal intercourse. Response options range from 1 "Never" to 5 "4 or more times".
Time Frame
9 months post intervention
Title
Frequency of communicating without abuse
Description
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".
Time Frame
3 months post intervention
Title
Frequency of communicating without abuse
Description
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".
Time Frame
9 months post intervention
Title
Clinic utilization
Description
Number of times receiving services or information from school-based health center on contraception, pregnancy, abortion, or sexually transmitted diseases
Time Frame
3 months post intervention
Title
Clinic utilization
Description
Number of times receiving services or information from school-based health center on contraception, pregnancy, abortion, or sexually transmitted diseases.
Time Frame
9 months post intervention
Title
Behavioral intentions to engage in sexual activity
Description
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.
Time Frame
3 months post intervention
Title
Behavioral intentions to engage in sexual activity
Description
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.
Time Frame
9 months post intervention
Title
Behavioral intentions to use condoms
Description
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.
Time Frame
3 months post intervention
Title
Behavioral intentions to use condoms
Description
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.
Time Frame
9 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin K Coyle, PhD
Organizational Affiliation
ETR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela M Anderson, PhD
Organizational Affiliation
ETR
Official's Role
Principal Investigator
Facility Information:
Facility Name
California School Based Health Alliance
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92182
Country
United States
Facility Name
ETR
City
Scotts Valley
State/Province
California
ZIP/Postal Code
95066
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
As part of our commitment to data security and confidentiality, IPD will not be shared outside the research team.
Citations:
PubMed Identifier
34468330
Citation
Anderson P, Coyle K, Guinosso S, Ferrand JL, Owora A, Houghton RF, Walsh-Buhi E. Promoting Adolescent Healthy Relationships (The About Us Program): Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2021 Sep 1;10(9):e30499. doi: 10.2196/30499.
Results Reference
derived

Learn more about this trial

A Healthy Relationships Program for Vulnerable Youth

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