Educational Game vs Genetic Counseling for Prenatal Screening Education
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Erin Rothwell
Disqualifiers: Previous prenatal screening, Genetic counseling, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Educational Game vs Genetic Counseling for Prenatal Screening Education?
Research shows that genetic counseling, whether through traditional methods or using educational tools like videotapes, can significantly increase knowledge about genetic conditions. This suggests that using educational games as part of prenatal screening education could also be effective in helping people understand important genetic information.12345
Is genetic counseling safe for prenatal screening education?
How does the treatment 'Educational Game vs Genetic Counseling for Prenatal Screening Education' differ from other treatments for prenatal screening education?
Eligibility Criteria
This trial is for English-speaking adults less than 15 weeks pregnant, attending their first or second OB clinic visit, including those in rural areas. Partners of the pregnant individuals can also join if they're adults and speak English. It's not for those who've had prenatal screening before or have a high-risk pregnancy with prior genetic counseling.Inclusion Criteria
Able to complete study tasks on a computer or smartphone from home
I am an adult who speaks English and my partner is pregnant.
I am less than 15 weeks pregnant.
See 1 more
Exclusion Criteria
I have a family history of genetic issues and have seen a genetic counselor.
Already had prenatal screening from this or previous pregnancies
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants are randomized to either game education, enhanced usual care, or one-on-one genetic counseling
6-14 weeks gestation
1-2 visits (in-person or tele-health)
Follow-up
Participants complete surveys to measure knowledge, satisfaction, and decisional conflict
20 weeks gestation
1 survey (remote)
Long-term Follow-up
Interviews with participants and clinicians to assess shared decision-making and information needs
Treatment Details
Interventions
- Genetic Counseling (Behavioural Intervention)
- Meaning of Screening (Behavioural Intervention)
- Usual Care (Behavioural Intervention)
Trial OverviewThe study compares a new educational game designed to teach about prenatal genetic screening against the usual one-on-one genetic counseling approach. The goal is to see if the game can effectively fill knowledge gaps where access to counselors is limited.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Game InterventionExperimental Treatment1 Intervention
The game intervention group will consist of pregnant women who will interact with the educational intervention also delivered on an electronic platform (n= 375 total, 125 per site). Participants will also receive whatever information is routinely provided in the clinic about prenatal screening such as the brochure and oral information by clinicians.
Group II: Usual CareActive Control1 Intervention
The usual care group will consist of pregnant women who receive no experimental intervention but 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, plus any additional clinic materials or oral information provided in conversation with clinicians (n= 375 total, 125 per site). We are transferring ACOG's prenatal screening education onto the electronic platform to control for any differences in attention that may be due to technology platform and to track time interacting with the material via the web portal.
Group III: Genetic CounselingActive Control1 Intervention
The one-on-one genetic counseling group will receive standard of care for genetic counseling delivered by a board-certified genetic counselor for pre-test education. The counselor will be conducting pre-test education and as with the other study groups, the decision about prenatal screening will be made at the clinical visit with the provider. This group receives also the same clinical materials and oral information by clinicians as the other two groups. Both in-person and tele-health genetic counseling options are available at all sites.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of North CarolinaChapel Hill, NC
University of AlabamaBirmingham, AL
University of UtahSalt Lake City, UT
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Who Is Running the Clinical Trial?
Erin RothwellLead Sponsor
National Human Genome Research Institute (NHGRI)Collaborator
References
Implementing prenatal screening for cystic fibrosis in routine obstetric practice. [2006]The purpose of this study was to assess the outcome of the type of prescreening counseling on choices for prenatal cystic fibrosis screening.
Discovering and addressing the client's lay construct of genetic disease: an important aspect of genetic healthcare? [2019]Genetic health care includes provision of information about (a) the cause of the condition, (b) recurrence risks, and (c) options for avoiding or treating the disease. This specialized aspect of health care may be offered by appropriately trained nurses, doctors or genetic counselors, but for brevity in this article the term "genetic counselor" will be used to describe any health professional providing such care. The accepted definitions of genetic counseling emphasize the transfer of information from the counselor to the client, to facilitate the client in making informed decisions (Ad Hoc Committee on Genetic Counseling, American Society of Human Genetics, 1975; Harper, 1998). However, it is important to recognize that both clients and counselors bring to the process of genetic counseling their own knowledge, values, and beliefs (Hallowell & Richards, 1997). The information provided during the genetic counseling process may not be novel to the client, and will be received against a background of the client's previous knowledge about the condition.
A follow-up study of genetic counseling in Down syndrome. [2015]To ascertain the effects of genetic counseling on the education of counselees, a questionnaire study on the acceptance of genetic knowledge was carried out among 126 parents of children with Down syndrome. Those parents from the "Down Syndrome Association" had best scores for knowledge, followed by those who had received counseling according to a designed format (programmed counseling) in this Hospital. Parental perceptions of the information needed in genetic counseling were also studied and it was found that most parents thought that the topics of education and medical care were more important than genetic information. Realization of such difference in primary concern between counselors and counselees may improve the effectiveness of genetic counseling.
Genetic counseling for beta-thalassemia trait following health screening in a health maintenance organization: comparison of programmed and conventional counseling. [2020]Providing adequate counseling of patients identified in genetic screening programs is a major responsibility and expense. Adults in a health maintenance organization, unselected for interest, were screened for beta-thalassemia trait as part of preventive health care. Counseling was provided by either a trained physician (conventional counseling) or by a videotape containing the same information followed by an opportunity to question a trained physician (programmed counseling). Immediately before and after counseling, knowledge of thalassemia, knowledge of genetics, and mood change were assessed by questionnaire. Comparable mood changes and similar learning about thalassemia and genetics occurred with both counseling methods. Thus, as judged by immediate effects on knowledge and mood, videotaped instruction can greatly reduce professional time required for genetic counseling and facilitate the incorporation of genetic screening into primary health care.
Prenatal screening for hemoglobinopathies. II. Evaluation of counseling. [2020]Learning during genetic counseling is often below expectations, especially in the context of genetic screening. In this report we describe learning as a result of genetic counseling of 298 pregnant women identified as hemoglobinopathy carriers, 234 with sickle cell trait and 64 with beta-thalassemia trait. Counseling was designed to provide the information needed in a simple, clear, and nondirective manner. A special videotape produced for this purpose provided dramatization and a role model illustrating an appropriate response. After viewing the videotape the counselee had an opportunity to question the counselor and to have any misconceptions corrected. Questionnaires revealed significantly increased knowledge as a result of counseling in each of the three hemoglobinopathy subject areas tested-namely, clinical manifestations, genetics, and prenatal diagnosis. Five factors correlated with higher knowledge scores after counseling-namely, a younger patient age, more years of education, knowledge of having trait before this identification, knowledge of the baby's father having trait before counseling, and having no prior children.
Communicating risk in prenatal genetic testing. [2009]Prenatal testing for Down syndrome and neural tube defects has become routine, and testing for other genetic conditions is becoming commonplace. Counseling about these tests involves a discussion of risk information, so pregnant women and their partners can use the information effectively when they make choices about testing. Discussing risk can be challenging, as many individuals, particularly those of lower literacy, have a poor understanding of the numerical concept of risk. Furthermore, whether risk is comprehended accurately or not, it is interpreted by patients in light of their existing knowledge and past experiences. Strategies available to optimize understanding of risk include communication of risk figures as frequencies rather than as probabilities or percentages and explicit discussion of a woman's preconceptions about her risk and about the condition being tested for.
Prenatal screening and genetics. [2019]Although the term 'genetic screening' has been used for decades, this paper discusses how, in its most precise meaning, genetic screening has not yet been widely introduced. 'Prenatal screening' is often confused with 'genetic screening'. As we show, these terms have different meanings, and we examine definitions of the relevant concepts in order to illustrate this point. The concepts are i) prenatal, ii) genetic screening, iii) screening, scanning and testing, iv) maternal and foetal tests, v) test techniques and vi) genetic conditions. So far, prenatal screening has little connection with precisely defined genetics. There are benefits but also disadvantages in overstating current links between them in the term genetic screening. Policy making and professional and public understandings about screening could be clarified if the distinct meanings of prenatal screening and genetic screening were more precisely observed.
Recent advances in prenatal genetic screening and testing. [2022]The introduction of new technologies has dramatically changed the current practice of prenatal screening and testing for genetic abnormalities in the fetus. Expanded carrier screening panels and non-invasive cell-free fetal DNA-based screening for aneuploidy and single-gene disorders, and more recently for subchromosomal abnormalities, have been introduced into prenatal care. More recently introduced technologies such as chromosomal microarray analysis and whole-exome sequencing can diagnose more genetic conditions on samples obtained through amniocentesis or chorionic villus sampling, including many disorders that cannot be screened for non-invasively. All of these options have benefits and limitations, and genetic counseling has become increasingly complex for providers who are responsible for guiding patients in their decisions about screening and testing before and during pregnancy.
What are the required components of pre- and post-test counseling? [2019]Prenatal care providers are faced with a myriad of decisions about how to offer genetic screening and testing in ways that are appropriate to their patient population and their workflow. Among the critical issues brought to the forefront of rapidly advancing genetic and genomic technologies is the importance of pre- and post-test counseling. This document is a synthesis of proceedings of a workshop sponsored by the American College of Obstetricians and Gynecologists, the American College of Medical Genetics and Genomics, and the Society for Maternal-Fetal Medicine, on January 24-25, 2017, during which invited experts discussed required components of pre- and post-test counseling and associated concerns in the provision of prenatal care.
Understanding the experiences and perspectives of prenatal screening among a diverse cohort. [2023]Rapid advances in prenatal genetic screening technology make it difficult for providers to deliver adequate prenatal counseling. The aim of this study was to understand how prenatal screening educational approaches can meet the needs of patients.
Implementing Group Prenatal Counseling for Expanded Noninvasive Screening Options. [2019]Recently, practices have begun integrating cell-free DNA-based noninvasive prenatal screening as a screening option for a variety of genetic conditions. According to the National Society of Genetic Counselors, the integration of cfDNA screening into clinical prenatal practice may "significantly shift the paradigm of prenatal testing and screening for all women." The purpose of this study was to determine whether group information sessions can feasibly serve as an alternative to extended one-on-one genetic counseling for the increasing number of women making decisions about prenatal testing and screening. This study assessed the effect of group genetic information sessions coupled with abbreviated counseling on pregnant women's knowledge about and attitudes toward prenatal testing and screening.