Comparing Game Facilitated Interactivity to Genetic Counseling for Prenatal Screening Education

NCT05360095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2045

Last updated 2026-01-27

No results posted yet for this study

Summary

Advancements in prenatal genetic screening have significantly improved the identification of chromosomal abnormalities and heritable conditions during pregnancy, yet current standards for patient education in this domain are largely ineffective. The most effective approach to education about prenatal screening is one-on-one genetic counseling, but due to the limited number of counselors this is not feasible, especially in rural and frontier areas. The investigators will address this national problem using a novel education game that can more effectively address this gap in healthcare decision-making.

Conditions

  • Genetic Counseling
  • Shared Decision Making
  • Pregnancy
  • Genetic Testing
  • Prenatal Disorder

Interventions

BEHAVIORAL

Meaning of Screening

The Meaning of Screening game is a decision making tool that is accessible through the most common web platforms. Users have the ability to explore learn about prenatal screening through multiple approaches, including presentation of facts, personal stories, and values clarification. Users will access the game from their personal phone or computer prior to completing prenatal screening.

BEHAVIORAL

Genetic Counseling

This intervention consists of a 45-minute prenatal screening genetic counseling session (in person or online) completed after confirmation of pregnancy and before actual screening.

BEHAVIORAL

Usual Care

Participants in the Usual Care group will receive the brochure-based education about prenatal screening that is currently recommended by American College of Obstetrics and Gynecology (ACOG), delivered in an electronic format so they can read it before they complete prenatal screening.

Sponsors & Collaborators

  • National Human Genome Research Institute (NHGRI)

    collaborator NIH
  • Erin Rothwell

    lead OTHER

Principal Investigators

  • Erin Rothwell, PhD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2026-01-10
Completion
2026-01-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05360095 on ClinicalTrials.gov