NCT03736876

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:

  1. 1.Nine months following the end of the program, what is the impact of About Us relative to the standard of care on:
  2. 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:
  3. 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:
  4. 4.Among those receiving About Us, how do effect sizes for the primary and secondary behavioral outcomes vary by dosage?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2021

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

3.3 years

First QC Date

August 22, 2018

Last Update Submit

March 22, 2022

Conditions

Pregnancy, UnplannedSexually Transmitted Diseases

Keywords

YouthAdolescentsTeensHealthy RelationshipsUnintended PregnancyTeen PregnancySexually Transmitted InfectionsSexually Transmitted DiseasesSexual Health EducationSchool-Based Health CenterRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Rates of abstinence of vaginal or anal sex

    3 months post intervention

  • Rates of abstinence of vaginal or anal sex

    9 months post intervention

  • Frequency of communicating without abuse

    3 months post intervention

  • Frequency of communicating without abuse

    9 months post intervention

  • Clinic utilization

    3 months post intervention

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

About UsBEHAVIORAL

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.

Treatment group

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

California School Based Health Alliance

Oakland, California, 94612, United States

Location

San Diego State University

San Diego, California, 92182, United States

Location

ETR

Scotts Valley, California, 95066, United States

Location

Related Publications (1)

  • 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.

    PMID: 34468330DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karin K Coyle, PhD

    ETR

    PRINCIPAL INVESTIGATOR

  • Pamela M Anderson, PhD

    ETR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2018

First Posted

November 9, 2018

Study Start

February 1, 2018

Primary Completion

May 11, 2021

Study Completion

May 12, 2021

Last Updated

March 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

As part of our commitment to data security and confidentiality, IPD will not be shared outside the research team.

Locations

US(3)