Avatar Contraception Communication Training

August 26, 2025 updated by: Jenny Francis, University of Texas Southwestern Medical Center

Improving Clinician Communication About Contraception Using Teen and Parent Avatars

In order to support the desire of most adolescents to delay pregnancy (parenting) until their own adulthood, pediatricians must be comfortable and skilled in having reproductive health conversations with adolescents and the mothers of adolescents. Advocates for Youth (AFY), a national, youth-facing, well-established, non-profit, is known for innovative sexual and reproductive health programs. AFY successfully implemented a virtual simulation for schoolteachers to practice sex education scenarios by interacting with culturally diverse student avatars. We will partner with AFY to adapt their novel simulation-based approach to train medical residents in using SDM with youth and parent avatars. Our long-term goal is to build clinician confidence in SDM and actual skills via simulation training with dyadic avatars. We will also explore how evaluation of clinician communication skills varies from youth-, parent-, and clinician-viewpoints.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Specific Aims seek to (1) iteratively adapt and refine the simulation training (1a) and measurement tools (1b) with three community advisory boards (CAB) of separate groups of teens, parents, and clinicians; and (2) conduct a proof-of-concept pre-post evaluation of clinician confidence in counseling dyads after one-time exposure to the simulation (n=100 medical residents). We will record residents' communications in the simulation and a subset of clinicians, parents, and adolescents from each CAB will evaluate residents' SDM skills via the Person-Centered Contraception Counseling (PCCC) scale. Hypothesis: Most medical residents (75%) will self-report improvement or stability in confidence with high acceptability of the simulation training. We will explore 1) overall concordance between self- and expert-reported evaluation outcomes (SDM skills, PCCC scale); 2) compare the distribution of each evaluation item by evaluator; and 3) explore correlations between scales by evaluator. Impact: This proof-of-concept study, co-developed and co-evaluated with community members and families, fills a gap in communication training to inform a future fully powered ORBIT stage 3 efficacy trial to test actual triadic communication in the real-world with comparator groups of medical residents across national training programs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390-0966
        • UT Southwestern Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jenny KR Francis, MD, MPH
      • Dallas, Texas, United States, 75207
        • Childrens Health Adolescent and Young Adult Medicine (AYA) Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jenny KR Francis, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria (providers):

  • Providers (medical residents, fellows, attendings)
  • Recruited from the Adolescent and Young Adult (AYA) Medicine Clinic at Children's Medical Center of Dallas.

Exclusion Criteria:

  • Unable to speak or read in Spanish/English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Avatar training
One hundred physician learners will train with the avatar communication training tool as a behavioral intervention. Before the training (T0), the learners will complete a pre-survey to assess their baseline confidence. At the start of training, after a brief introduction and orientation to the tool, the learners will complete a 10-min uninterrupted scenario with a teen-parent avatar dyad about a contraception scenario. After the initial scenario (T1), the learner will pause and complete an assessment to evaluate use of SDM (Shared decision making) skills and PCCC (person-centered contraceptive counseling). Then, the learner will train for an hour with the tool. At the end (T2), the learner will complete another uninterrupted scenario and evaluate their confidence, SDM, and PCCC skills.
Behavioral: avatar communication training
Avatar simulates a mother and a daughter for the pediatrician to practice communication about contraception.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Questionnaire
Time Frame: Change from baseline (T0) at 0 hours, and end of training (T2) at 2 hours
Multiple questions will be aggregated to arrive at one reported value to determine "improvement or stability in confidence" in shared decision-making communication.
Change from baseline (T0) at 0 hours, and end of training (T2) at 2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability Questionnaire
Time Frame: At end of study (T2) at 2-hours
Weiners implementation outcome measure Acceptability of Intervention Measure (AIM). Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean with the higher score meaning acceptability.
At end of study (T2) at 2-hours
Questionnaire
Time Frame: Change from start (T1) at 20 minute to end of training (T2) at 2 hours
Self-reported evaluation of a behavioral outcome (SDM (shared decision-making) skills and PCCC (person-centered contraception counseling) from start (T1) to end of training (T2)
Change from start (T1) at 20 minute to end of training (T2) at 2 hours
Questionnaire
Time Frame: Change from start (T1) at 20 minute to end of training (T2) at 2 hours
Expert evaluation of behavioral outcome (SDM (shared decision-making) skills and PCCC (person-centered contraception counseling) from start (T1) to end of training (T2)
Change from start (T1) at 20 minute to end of training (T2) at 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jenny KR Francis, MD, UTSouthwestern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pending funding

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will collect 100 pre-post-surveys from clinicians in training, and 300 survey evaluations of video recordings. The study protocol, data tracking forms, survey, code book, data dictionary and a glossary of domain-specific terms will be shared in a portable document format (PDF).

IPD Sharing Time Frame

12mo after collection and available per Institutional Review Board standards

IPD Sharing Access Criteria

All deidentified study data that are not designated as restricted use will be made available as public use data to the research community via DSDR.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings