Pregnancy, UnplannedNCT03736876
A Healthy Relationships Program for Vulnerable Youth
A study testing About Us in people with Pregnancy, Unplanned and Sexually Transmitted Diseases, run by ETR Associates at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Unplanned, Sexually Transmitted Diseases
- What is being tested?
- About Us
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2018to 12 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
California School Based Health Alliance
Oakland, California, 94612
San Diego State University
San Diego, California, 92182
ETR
Scotts Valley, California, 95066
About this study
Official title: About Us: 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:
- 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?
Read the 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.
- Being tested
- About Us
- 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
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
About UsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 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. Receives: Behavioral: About Us |
| Delayed intervention (control group) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of vaginal or anal sex without condoms
Reported number of times having had vaginal or anal sex without using condoms or insertive condoms.
Measured: 9 months post intervention
Secondary outcomes (10)
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".
Measured: 3 months post intervention
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".
Measured: 9 months post intervention
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".
Measured: 3 months post intervention
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".
Measured: 9 months post intervention
Clinic utilization
Number of times receiving services or information from school-based health center on contraception, pregnancy, abortion, or sexually transmitted diseases
Measured: 3 months post intervention
Clinic utilization
Number of times receiving services or information from school-based health center on contraception, pregnancy, abortion, or sexually transmitted diseases.
Measured: 9 months post intervention
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.
Measured: 3 months post intervention
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.
Measured: 9 months post intervention
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.
Measured: 3 months post intervention
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.
Measured: 9 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Feb 2018
- Primary completion11 May 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, UnplannedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETR Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Family and Youth Services Bureau, San Diego State University, California School-Based Health Alliance
- Responsible party
- Sponsor
- Investigators
- Karin K Coyle, PhD, Principal investigator, ETRPamela M Anderson, PhD, Principal investigator, ETR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736876
- Sponsor's protocol ID
- 90 AP2682-01-00
- Status last verified
- Mar 2022
- First submitted
- 22 Aug 2018
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As part of our commitment to data security and confidentiality, IPD will not be shared outside the research team.
Publications
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.
PubMed 34468330
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- About Us: A Healthy Relationships Program for Vulnerable Youth
- ClinicalTrials.gov ID
- NCT03736876
- Acronym / sponsor ID
- 90 AP2682-01-00
- Keywords
- Youth, Adolescents, Teens, Healthy Relationships, Unintended Pregnancy, Teen Pregnancy, Sexually Transmitted Infections, Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- ETR AssociatesUniversity, hospital or other
- Collaborators
- Family and Youth Services Bureau, San Diego State University, California School-Based Health Alliance
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: About UsThese 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. |
| Delayed intervention (control group) | No intervention | –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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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:
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| About UsEach 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. | Behavioural | Treatment group |
Primary outcome
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.
10 secondary outcomes
Rates of abstinence of vaginal or anal sex
Time frame: 3 months post intervention
Rates of abstinence of vaginal or anal sex
Time frame: 9 months post intervention
Frequency of communicating without abuse
Time frame: 3 months post intervention
Frequency of communicating without abuse
Time frame: 9 months post intervention
Clinic utilization
Time frame: 3 months post intervention
Clinic utilization
Time frame: 9 months post intervention
Behavioral intentions to engage in sexual activity
Time frame: 3 months post intervention
Behavioral intentions to engage in sexual activity
Time frame: 9 months post intervention
Behavioral intentions to use condoms
Time frame: 3 months post intervention
Behavioral intentions to use condoms
Time frame: 9 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Derived from this study: PubMed 34468330Anderson 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.
- Individual participant dataSharing planned: No. As part of our commitment to data security and confidentiality, IPD will not be shared outside the research team.
Related trials for Pregnancy, Unplanned
Active, not recruiting
Group-based Life Skills and Health Empowerment for Married Women to Avoid Unintended Pregnancies in India
Pregnancy, Unplanned, Contraceptive Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin K Coyle, PhD principal investigator
ETR
Pamela M Anderson, PhD principal investigator
ETR
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing About Us in people with Pregnancy, Unplanned and Sexually Transmitted Diseases, run by ETR Associates at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of vaginal or anal sex without condoms (time frame: 9 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03736876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022; AzTrials last refreshed its copy on 29 Oct 2026.