Educational Game vs Genetic Counseling for Prenatal Screening Education

Recruiting at 2 trial locations

Overseen By Erin Johnson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Erin Rothwell

Disqualifiers: Previous prenatal screening, Genetic counseling, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

1125 Participants Needed

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. ^{1 2 3 4 5}

Is genetic counseling safe for prenatal screening education?

The research does not provide specific safety data for genetic counseling or educational games used in prenatal screening education, but these methods are generally considered safe as they involve providing information and guidance rather than medical procedures. ^{5 6 7 8 9}

How does the treatment 'Educational Game vs Genetic Counseling for Prenatal Screening Education' differ from other treatments for prenatal screening education?

This treatment is unique because it compares the use of an educational game to traditional genetic counseling for teaching about prenatal screening, offering a potentially more engaging and accessible way to understand complex genetic information. ^{3 5 7 10 11}

Research Team

Erin Rothwell, PhD

Principal Investigator

University of Utah

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.

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

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
• Meaning of Screening
• Usual Care

Trial Overview The 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

Group I: Game Intervention Experimental Treatment 1 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 Care Active Control 1 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 Counseling Active Control 1 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.

Who Is Running the Clinical Trial?

Erin Rothwell

Lead Sponsor

Trials

2

Recruited

7,100+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials

273

Recruited

299,000+

Findings from Research

Both group genetic counseling methods (presentation by a genetics professional and audiovisual presentation) effectively improved patients' knowledge about prenatal cystic fibrosis screening, with no significant difference in screening choices between the two methods.

Fifty-eight percent of patients opted for screening, leading to the identification of 15 mutation carriers, but partner testing was challenging, highlighting potential issues in mobile populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing prenatal screening for cystic fibrosis in routine obstetric practice. Fries, MH., Bashford, M., Nunes, M.[2006]

Genetic counseling provides essential information about the causes of genetic conditions, recurrence risks, and treatment options, helping clients make informed decisions about their health.

The effectiveness of genetic counseling is influenced by the existing knowledge, values, and beliefs of both the client and the counselor, highlighting the importance of personalized communication in the counseling process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovering and addressing the client's lay construct of genetic disease: an important aspect of genetic healthcare? Skirton, H., Eiser, C.[2019]

A study involving 126 parents of children with Down syndrome found that those who received genetic counseling had better knowledge about the condition, especially parents from the Down Syndrome Association.

Parents prioritized education and medical care topics over genetic information in counseling, suggesting that addressing these concerns could enhance the effectiveness of genetic counseling sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A follow-up study of genetic counseling in Down syndrome. Lin, SJ., Huang, MC., Chen, SH., et al.[2015]

Both conventional counseling by a physician and programmed counseling using a videotape resulted in similar improvements in knowledge about beta-thalassemia and genetics among adults screened for the trait, indicating that the method of delivery does not significantly affect learning outcomes.

Using videotaped counseling can significantly reduce the time healthcare professionals spend on genetic counseling while still effectively educating patients, making it a practical option for integrating genetic screening into primary health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic counseling for beta-thalassemia trait following health screening in a health maintenance organization: comparison of programmed and conventional counseling. Fisher, L., Rowley, PT., Lipkin, M.[2020]

A study involving 298 pregnant women who were carriers of hemoglobinopathies showed that genetic counseling significantly improved their knowledge about clinical manifestations, genetics, and prenatal diagnosis related to their conditions.

Factors such as younger age, higher education, prior knowledge of their carrier status, and having no previous children were associated with better knowledge scores after counseling, indicating that these elements may enhance the effectiveness of genetic counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal screening for hemoglobinopathies. II. Evaluation of counseling. Loader, S., Sutera, CJ., Walden, M., et al.[2020]

Prenatal testing for conditions like Down syndrome and neural tube defects is now routine, but effectively communicating the associated risks to expectant parents can be challenging, especially for those with lower literacy levels.

To improve understanding of risk, it is recommended to present risk information as frequencies instead of percentages and to engage in discussions about the individual's preconceptions regarding their risk and the conditions being tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating risk in prenatal genetic testing. Gates, EA.[2009]

The paper clarifies that 'genetic screening' and 'prenatal screening' are distinct concepts, with prenatal screening currently lacking a strong connection to precise genetic definitions.

By accurately defining these terms, the paper suggests that it could improve policy-making and public understanding regarding the benefits and limitations of screening practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal screening and genetics. Alderson, P., Aro, AR., Dragonas, T., et al.[2019]

New technologies in prenatal screening, such as expanded carrier screening and non-invasive cell-free fetal DNA tests, have improved the detection of genetic abnormalities in fetuses, allowing for earlier and more comprehensive assessments.

Advanced methods like chromosomal microarray analysis and whole-exome sequencing can diagnose a wider range of genetic conditions from invasive samples, but they also complicate genetic counseling for healthcare providers as they navigate the benefits and limitations of these options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in prenatal genetic screening and testing. Van den Veyver, IB.[2022]

Prenatal care providers must navigate complex decisions regarding genetic screening and testing, emphasizing the need for tailored approaches that fit their patient populations and workflows.

The workshop highlighted the critical role of pre- and post-test counseling in genetic testing, ensuring that patients receive appropriate information and support throughout the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the required components of pre- and post-test counseling? Rink, BD., Kuller, JA.[2019]

A study involving 22 racially and ethnically diverse women revealed that current prenatal screening educational methods do not adequately meet patients' needs for understanding, especially regarding high-risk results.

Participants suggested that a standardized decision aid could enhance knowledge and reduce confusion by providing clear information about testing options, conditions screened, timelines, costs, and using non-technical language.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the experiences and perspectives of prenatal screening among a diverse cohort. Riches, NO., Johnson, EP., Subramaniam, A., et al.[2023]

The study explored the feasibility of using group information sessions as an alternative to traditional one-on-one genetic counseling for prenatal testing, which is becoming increasingly important with the rise of cell-free DNA screening.

Results indicated that these group sessions, combined with shorter counseling, effectively improved pregnant women's knowledge and attitudes towards prenatal testing, suggesting a potential shift in how genetic counseling can be delivered to accommodate more women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Group Prenatal Counseling for Expanded Noninvasive Screening Options. Gammon, BL., Otto, L., Wick, M., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Implementing prenatal screening for cystic fibrosis in routine obstetric practice. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Discovering and addressing the client's lay construct of genetic disease: an important aspect of genetic healthcare? [2019]

3. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

A follow-up study of genetic counseling in Down syndrome. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Genetic counseling for beta-thalassemia trait following health screening in a health maintenance organization: comparison of programmed and conventional counseling. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Prenatal screening for hemoglobinopathies. II. Evaluation of counseling. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Communicating risk in prenatal genetic testing. [2009]

7. England pubmed.ncbi.nlm.nih.gov

Prenatal screening and genetics. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Recent advances in prenatal genetic screening and testing. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

What are the required components of pre- and post-test counseling? [2019]

10. England pubmed.ncbi.nlm.nih.gov

Understanding the experiences and perspectives of prenatal screening among a diverse cohort. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Implementing Group Prenatal Counseling for Expanded Noninvasive Screening Options. [2019]