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Game-Based Decision Aid to Educate Pregnant Women About Prenatal Screening

Improved Prenatal Genetic Screening Decision Making Through Interactive Technology

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03441672
Enrollment
79
Registered
2018-02-22
Start date
2016-11-01
Completion date
2017-03-30
Last updated
2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prenatal Disorder

Keywords

Prenatal Screening, Interactive educational technology

Brief summary

Significant barriers exist for effectively informing women about prenatal screening in the clinical setting. This project developed and evaluated the efficacy of a game decision aid among pregnant women about prenatal screening in a randomized controlled study.

Detailed description

Prenatal genetic screening has grown at a rapid rate and whole genome sequence of an unborn fetus is expected to be widely available in the next few years. However, significant barriers remain for effectively informing couples about their risks and options for identifying and managing chromosomal anomalies and heritable conditions during pregnancy. It is widely recognized that current standards for patient education in this domain are largely ineffective. Decisions about prenatal screening are based on pregnant couples' values and knowledge so clinicians are often challenged with being informative but non-directive. Prenatal screening has grown significantly in recent years because the American College of Obstetricians and Gynecologists recommends prenatal care providers now offer all women prenatal genetic screening in the first trimester of pregnancy, regardless of age, or genetic risk status. This has moved the focus of prenatal screening from a subset of higher risk pregnant couples to all pregnant couples and to an earlier time in pregnancy. To address these information needs, we are undertaking a novel approach to inform couples about screening. Gaming tools have demonstrated promising outcomes for improved health care decision-making and compliance with health recommendations. In contrast to other computer applications for the dissemination of information, game technology goes beyond information delivery and engages users in different life choice scenarios. Further, these tools can assess whether the attractiveness (or unattractiveness) of different simulated choices can offer insights about one's values. In this value-laden context, the game allows individuals to explore their personal values in a non-directive fashion and allows a comparison of the game choices and values with an individual's reproductive partner. The purpose of this application is to 1) develop a prenatal screening gaming application prototype (PS-GAP) and 2) conduct a preliminary assessment of the PS-GAP on knowledge, satisfaction, and decisional conflict about prenatal genetic screening for pregnant women and their partners.

Interventions

Interactive technology game providing education about prenatal screening and what the results may mean.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Utah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* English speaking * less than 15 weeks gestation * attending first obstetric visit * low risk pregnancy

Exclusion criteria

* Non-English speaking * High risk pregnancy * Past 15 weeks gestation

Design outcomes

Primary

MeasureTime frameDescription
Level of knowledge about prenatal screening and prenatal diagnostic testingImmediately after interventionprenatal screening knowledge is measured with a 23-item survey developed by an expert panel of genetic counselors, physicians, social scientists and data collection experts. All questions use a five point likert scale for response.

Secondary

MeasureTime frameDescription
Documentation of decision to undergo prenatal screeningUp to 4 weeks after interventionDocumentation of participant's decision to complete prenatal screening or not, as pulled from the medical record.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026