NCT05995574

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
50mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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 Progress3%
Apr 2026Jun 2030

First Submitted

Initial submission to the registry

May 16, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
2.6 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

4.2 years

First QC Date

May 16, 2023

Last Update Submit

August 26, 2025

Conditions

Keywords

AdolescentContraceptionTraining

Outcome Measures

Primary Outcomes (1)

  • Questionnaire

    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 Outcomes (3)

  • Acceptability Questionnaire

    At end of study (T2) at 2-hours

  • Questionnaire

    Change from start (T1) at 20 minute to end of training (T2) at 2 hours

  • Questionnaire

    Change from start (T1) at 20 minute to end of training (T2) at 2 hours

Study Arms (1)

Avatar training

EXPERIMENTAL

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

Interventions

Avatar simulates a mother and a daughter for the pediatrician to practice communication about contraception.

Avatar training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable to speak or read in Spanish/English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Childrens Health Adolescent and Young Adult Medicine (AYA) Clinic

Dallas, Texas, 75207, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-0966, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jenny KR Francis, MD

    UTSouthwestern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny KR Francis, MD, MPH

CONTACT

Jenny KR Francis, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: single intervention arm with pre- and post- evaluation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 16, 2023

First Posted

August 16, 2023

Study Start

April 1, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
12mo after collection and available per Institutional Review Board standards
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.

Locations