Adolescent Contraception: Communication Training Intervention to Engage Pediatrician-Adolescent-Mother Triads

Communication Clinical Trial

Official title:

Adolescent Contraception: Communication Training Intervention to Engage Pediatrician-Adolescent-Mother Triads

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05995574
• Other study ID #: STU-2023-0462
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2025
• Est. completion date: March 31, 2029

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Stephanie M Reyes, MA
• Phone: 214-456-6792
• Email: stephanie.reyes[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Artificial intelligence, such as a chatbot, could be programmed to simulate the perspective of the mother or the daughter as a tool for pediatricians to practice communication before interacting with "real" families. Through human-centered design, an iterative problem-solving approach, our overall goal is to develop and test a communication training chatbot tool that is accurate, developmentally tailored for adolescents and mothers, culturally tailored, and aids pediatricians to manage resistance and conflict about contraception to ultimately close disparities in teen births. The investigator's primary hypothesis is that a communication focused intervention will improve pediatrician interactions with dyads about contraception. Through three stages, the study team will develop an artificial intelligence tool as a behavioral intervention. The study team will gather basic communication data to generate, refine, modify, adapt, and pilot test novel communication tools with real-world encounters while keeping humans at the center of attention

Description:

In Stage 1 (formative), the investigators will characterize communication content and styles of pediatricians (residents, fellows, attendings) and adolescent-mother dyads on contraception discussions with 50 real-life clinical encounters. Through separate post-encounter surveys of each pediatrician-adolescent-parent "triad" using validated scales, the investigators will describe the overall quality of the interactions (concordant contraception plans, satisfaction), communication (confidence, comfort, self-efficacy, confidentiality) and decision-making (perceived autonomy, ownership, and power) to determine "ideal, moderate and poor" communication interactions. Then, separate group interviews (n = 15, with adolescents, mothers and physicians) will review recorded vignettes to identify optimal culturally tailored communication strategies. In Stage 2 (development), the investigators will upload de-identified and anonymized vignettes to an AI communication training tool to develop and refine the tool through prompt engineering and performance evaluation with adolescent, parent and pediatrician advisory boards. Then, the investigators will iteratively test the acceptability and feasibility of the tool on 10 pediatrician learners. In Stage 3 (proof-of-concept), the investigators will test how an AI communication intervention tool can improve reproductive health encounters by comparing evaluation results of 50 pre-training and 50 post-training real encounters. This study will advance pediatrician communication training, empower adolescent sexual health, support mothers' priorities, and test how AI communication training chatbots can improve triadic interactions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 465
• Est. completion date: March 31, 2029
• Est. primary completion date: March 31, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria (pediatricians/providers):

• Pediatricians (residents, fellows, attendings)

• Recruited from the Adolescent and Young Adult (AYA) Medicine Clinic at Children's Medical Center of Dallas.

Inclusion Criteria (adolescents and young adults):

• Adolescents (14-17 years of age)

• Young adults (18-21 years of age)

• Recruited from the Adolescent and Young Adult (AYA) Medicine Clinic at Children's Medical Center of Dallas.

Inclusion Criteria (caregivers):

• Caregiver (1) of recruited patients who attend the encounter with the patients

• Recruited from the Adolescent and Young Adult (AYA) Medicine Clinic at Children's Medical Center of Dallas.

Exclusion Criteria:

• Adolescent/young adult is not an active patient

• Unable to speak or read in Spanish/English

Related Conditions & MeSH terms

• Communication

Intervention

Behavioral:
• chatbot communication training
Artificial intelligence chatbot that simulates a mother and a daughter for the pediatrician to practice communication about contraception.

Locations

Country	Name	City	State
United States	Children's Health Adolescent and Young Adult Medicine (AYA) Clinic	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire	Multiple questions will be aggregated to arrive at one reported value to determine "ideal, moderate and poor" communication interactions.	Pre-training, baseline.
Primary	Questionnaire	Multiple questions will be aggregated to arrive at one reported value to determine "ideal, moderate and poor" communication interactions after training.	Post-training, through study completion, an average of 1 year.
Secondary	Acceptability Questionnaire	Weiner's 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.	Through study completion, an average of 1 year.
Secondary	Feasibility Questionnaire	Weiner's implementation outcome measure Feasibility of Intervention Measure (FIM). Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean with the higher score meaning feasibility.	Through study completion, an average of 1 year.