Genetic CounselingNCT05360095
Comparing Game Facilitated Interactivity to Genetic Counseling for Prenatal Screening Education
A study testing Meaning of Screening and Genetic Counseling in people with Genetic Counseling and Shared Decision Making, run by Erin Rothwell at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genetic Counseling, Shared Decision Making, Pregnancy
- What is being tested?
- Meaning of Screening and Genetic Counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,045 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Mar 2023to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult
- English-speaking people who are attending their first or second OB clinic visit including rural referral centers
- less than 15 weeks pregnant.
- Partner of the pregnant person who speaks English and is an adult
- Able to complete study tasks on a computer or smartphone from home
Who cannot join
- already had prenatal screening from this or previous pregnancies,
- have obstetric or family history of chromosomal abnormalities, or genetic high-risk pregnancy and have already met with a genetic counseling about prenatal screening
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama
Birmingham, Alabama, 35233
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Utah
Salt Lake City, Utah, 84112
About this study
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.
Read the detailed description
The American College of Obstetricians and Gynecologists recommends prenatal care providers offer all women prenatal genetic screening (henceforth prenatal screening) in the first trimester of pregnancy, regardless of age or risk status. This has moved the focus of prenatal screening from a subset of higher risk couples to all pregnant couples. Classically, information about prenatal screening has been provided to patients by written materials and discussions with providers during clinic visits. This approach has a number of weaknesses, including limited time, biases presented by provider perceptions of risk level, and limited clinician genetic knowledge. These factors may also contribute to disparities in screening uptake among under-represented populations during pregnancy. The most effective approach to education about prenatal screening is genetic counseling, but due to the limited number of counselors this is not feasible, especially in rural and frontier areas.
New innovative education games offer promise to more effectively address healthcare decision-making by educating patients before or outside of genetic counseling or clinic interaction. Providing engaging game-based education may result in a less labor-intensive method of genetic counseling and promote a more quality professional dialogue with clinicians. It is important to note that decision-making about prenatal screening is a complex medical issue; the term "game" refers to "serious game design" driven by theory. Game technology can display complex information in a culturally and linguistically appropriate format to individuals of diverse educational backgrounds that make them ideal for prenatal screening education especially among under-representative and rural populations. In fact, games have already been successfully applied to diabetes management, medication education and obesity.
The research team completed an R21 that developed and formally evaluated a novel prenatal screening education game, titled the "Meaning of Screening", in the clinical setting. Participants (n=73) were randomized to either the gaming intervention or usual care group. Outcomes demonstrated significant improvements in knowledge (p=.004) and high user satisfaction in the intervention group. The research team is now poised to evaluate this intervention among a wide range of health literacy levels in a national sample of pregnant couples from both rural and urban areas. The central hypothesis is that a game education tool for pre-test education will be equivalent to one-on-one genetic counseling and significantly better than enhanced usual care on knowledge, decisional conflict and shared decision-making.
Aim 1: To compare the effectiveness of a prenatal screening education game to improve knowledge and reduce decisional conflict among pregnant people with a diverse range of health literacy levels.
Methods: Working with three sites across the US, the research team will recruit 1125 pregnant people during their first trimester of pregnancy (40% from underrepresented groups and 40% from rural/frontier areas). Prior to the first or second obstetric appointment, participants will be randomized to a) game education only, b) enhanced usual care (an interactive pdf of the clinic's brochure) or c) one-on-one genetic counseling (in-person or tele-health). Immediately after their appointment and again at 20 weeks gestation they will complete surveys to measure knowledge, satisfaction, and decisional conflict. The research team will also test the impact on several exploratory measures (e.g. satisfaction, non-directiveness, clarity).
Aim 2: To assess the effectiveness of the prenatal screening education game to promote shared decision making with providers compared to enhanced usual care (an interactive pdf of the clinic's brochure) or one-on-one genetic counseling (in-person or tele-health).
Methods: Pregnant people will independently complete surveys about shared decision making with their provider. Interviews with pregnant people and clinicians will also be conducted to identify how the game impacted information needs, preferences and shared decision-making.
Aim 3: To compare the effectiveness of a prenatal screening education game to improve knowledge and reduce decisional conflict among partners of pregnant people.
Methods: Partners will be recruited and assigned to the same study group as their pregnant partner and will engage with the game, enhanced usual care or one-on-one genetic counseling (with their pregnant partner). Partners will independently complete surveys to measure knowledge, decisional conflict, and perceptions of shared decision making with the provider.
- Being tested
- Meaning of Screening, Genetic Counseling, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meaning of ScreeningBehavioural
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.
Genetic CounselingBehavioural
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.
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care |
| Game Intervention | Experimental | 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. Receives: Behavioral: Meaning of Screening |
| Genetic Counseling | Active comparator | 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. Receives: Behavioral: Genetic Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prenatal Screening Knowledge
Knowledge of Prenatal Screening survey determines how well a patient understands important aspects of prenatal genetic screening. It will be adapted from the multidimensional measure of informed choice (MMIC). The knowledge score will range from 0 to 12 with higher scores indicating greater knowledge.
Measured: Baseline (between 6 and 12 weeks gestation), after clinic visit (between 10 and 14 weeks gestation) and at 20 weeks gestation
Secondary outcomes (2)
Change in Decisional Conflict
The decisional conflict scale is a highly used scale for patients to evaluate a decision support tool regarding uncertainty in choosing options, factors related to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. The decisional conflict scale score ranges from 0 to 64 with lower scores indicating less decisional conflict.
Measured: After clinic visit (between 10 and 14 weeks gestation) and again at 20 weeks gestation
Shared Decision Making
We will ask a single question about partner involvement and questions from the SDM-Q-9 regarding how involved the provider was in the decision making process.
Measured: After clinic visit (between 10 and 14 weeks gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start7 Mar 2023
- Primary completion10 Jan 2026
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic CounselingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be recruited and randomized into three different groups, all running in parallel to each other.
- Masking
- None (open label)
- Enrolment
- 2,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erin Rothwell
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor-investigator, Erin Rothwell, University of Utah
- Investigators
- Erin Rothwell, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360095
- Sponsor's protocol ID
- 00101479
- Other IDs
- R01HG011921
- Status last verified
- Jan 2026
- First submitted
- 6 Apr 2022
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Game Facilitated Interactivity to Genetic Counseling for Prenatal Screening Education
- ClinicalTrials.gov ID
- NCT05360095
- Acronym / sponsor ID
- 00101479
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,045 participants (actual)
- Lead sponsor
- Erin RothwellUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The American College of Obstetricians and Gynecologists recommends prenatal care providers offer all women prenatal genetic screening (henceforth prenatal screening) in the first trimester of pregnancy, regardless of age or risk status. This has moved the focus of prenatal screening from a subset of higher risk couples to all pregnant couples. Classically, information about prenatal screening has been provided to patients by written materials and discussions with providers during clinic visits. This approach has a number of weaknesses, including limited time, biases presented by provider perceptions of risk level, and limited clinician genetic knowledge. These factors may also contribute to disparities in screening uptake among under-represented populations during pregnancy. The most effective approach to education about prenatal screening is genetic counseling, but due to the limited number of counselors this is not feasible, especially in rural and frontier areas.
New innovative education games offer promise to more effectively address healthcare decision-making by educating patients before or outside of genetic counseling or clinic interaction. Providing engaging game-based education may result in a less labor-intensive method of genetic counseling and promote a more quality professional dialogue with clinicians. It is important to note that decision-making about prenatal screening is a complex medical issue; the term "game" refers to "serious game design" driven by theory. Game technology can display complex information in a culturally and linguistically appropriate format to individuals of diverse educational backgrounds that make them ideal for prenatal screening education especially among under-representative and rural populations. In fact, games have already been successfully applied to diabetes management, medication education and obesity.
The research team completed an R21 that developed and formally evaluated a novel prenatal screening education game, titled the "Meaning of Screening", in the clinical setting. Participants (n=73) were randomized to either the gaming intervention or usual care group. Outcomes demonstrated significant improvements in knowledge (p=.004) and high user satisfaction in the intervention group. The research team is now poised to evaluate this intervention among a wide range of health literacy levels in a national sample of pregnant couples from both rural and urban areas. The central hypothesis is that a game education tool for pre-test education will be equivalent to one-on-one genetic counseling and significantly better than enhanced usual care on knowledge, decisional conflict and shared decision-making.
Aim 1: To compare the effectiveness of a prenatal screening education game to improve knowledge and reduce decisional conflict among pregnant people with a diverse range of health literacy levels.
Methods: Working with three sites across the US, the research team will recruit 1125 pregnant people during their first trimester of pregnancy (40% from underrepresented groups and 40% from rural/frontier areas). Prior to the first or second obstetric appointment, participants will be randomized to a) game education only, b) enhanced usual care (an interactive pdf of the clinic's brochure) or c) one-on-one genetic counseling (in-person or tele-health). Immediately after their appointment and again at 20 weeks gestation they will complete surveys to measure knowledge, satisfaction, and decisional conflict. The research team will also test the impact on several exploratory measures (e.g. satisfaction, non-directiveness, clarity).
Aim 2: To assess the effectiveness of the prenatal screening education game to promote shared decision making with providers compared to enhanced usual care (an interactive pdf of the clinic's brochure) or one-on-one genetic counseling (in-person or tele-health).
Methods: Pregnant people will independently complete surveys about shared decision making with their provider. Interviews with pregnant people and clinicians will also be conducted to identify how the game impacted information needs, preferences and shared decision-making.
Aim 3: To compare the effectiveness of a prenatal screening education game to improve knowledge and reduce decisional conflict among partners of pregnant people.
Methods: Partners will be recruited and assigned to the same study group as their pregnant partner and will engage with the game, enhanced usual care or one-on-one genetic counseling (with their pregnant partner). Partners will independently complete surveys to measure knowledge, decisional conflict, and perceptions of shared decision making with the provider.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be recruited and randomized into three different groups, all running in parallel to each other.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareThe 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. |
| Game Intervention | Experimental | Behavioral: Meaning of ScreeningThe 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. |
| Genetic Counseling | Active comparator | Behavioral: Genetic CounselingThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult
- English-speaking people who are attending their first or second OB clinic visit including rural referral centers
- less than 15 weeks pregnant.
- Partner of the pregnant person who speaks English and is an adult
- Able to complete study tasks on a computer or smartphone from home
Key exclusion criteria (2 listed)
- already had prenatal screening from this or previous pregnancies,
- have obstetric or family history of chromosomal abnormalities, or genetic high-risk pregnancy and have already met with a genetic counseling about prenatal screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meaning of ScreeningThe 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. | Behavioural | Game Intervention |
| Genetic CounselingThis intervention consists of a 45-minute prenatal screening genetic counseling session (in person or online) completed after confirmation of pregnancy and before actual screening. | Behavioural | Genetic Counseling |
| Usual CareParticipants 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. | Behavioural | Usual Care |
Primary outcome
Change in Prenatal Screening Knowledge
Time frame: Baseline (between 6 and 12 weeks gestation), after clinic visit (between 10 and 14 weeks gestation) and at 20 weeks gestation
Knowledge of Prenatal Screening survey determines how well a patient understands important aspects of prenatal genetic screening. It will be adapted from the multidimensional measure of informed choice (MMIC). The knowledge score will range from 0 to 12 with higher scores indicating greater knowledge.
2 secondary outcomes
Change in Decisional Conflict
Time frame: After clinic visit (between 10 and 14 weeks gestation) and again at 20 weeks gestation
Shared Decision Making
Time frame: After clinic visit (between 10 and 14 weeks gestation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Rothwell, PhD principal investigator
University of Utah
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meaning of Screening and Genetic Counseling in people with Genetic Counseling and Shared Decision Making, run by Erin Rothwell at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prenatal Screening Knowledge (time frame: Baseline (between 6 and 12 weeks gestation), after clinic visit (between 10 and 14 weeks gestation) and at 20 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.