- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05995574
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
166
Phase
- 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
- Name: Jenny KR Francis, MD, MPH
- Phone Number: 214-456-6792
- Email: jenny.francis@utsouthwestern.edu
Study Contact Backup
- Name: Jenny KR Francis, MD, MPH
- Phone Number: 214-456-6792
- Email: jkrfrancis@gmail.com
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390-0966
- UT Southwestern Medical Center
-
Contact:
- Jenny KR Francis, MD, MPH
- Phone Number: 214-456-6792
- Email: jenny.francis@utsouthwestern.edu
-
Contact:
- Jenny KR Francis, MD, MPH
- Phone Number: 214-456-6792
- Email: jkrfrancis@gmail.com
-
Principal Investigator:
- Jenny KR Francis, MD, MPH
-
Dallas, Texas, United States, 75207
- Childrens Health Adolescent and Young Adult Medicine (AYA) Clinic
-
Contact:
- Jenny K Francis, MD
- Phone Number: 214-456-6792
- Email: jenny.francis@utsouthwestern.edu
-
Contact:
- May KR Lau, MD
- Phone Number: 214-456-9099
- Email: may.lau@utsouthwestern.edu
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
Avatar simulates a mother and a daughter for the pediatrician to practice communication about contraception.
|
What is the study measuring?
Primary Outcome Measures
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
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.
Investigators
- 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)
April 1, 2026
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
June 30, 2030
Study Registration Dates
First Submitted
May 16, 2023
First Submitted That Met QC Criteria
August 15, 2023
First Posted (Actual)
August 16, 2023
Study Record Updates
Last Update Posted (Estimated)
September 3, 2025
Last Update Submitted That Met QC Criteria
August 26, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
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