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Educational Game vs Genetic Counseling for Prenatal Screening Education

N/A

Recruiting

Led By Erin Rothwell, PhD

Research Sponsored by Erin Rothwell

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Less than 15 weeks pregnant

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after clinic visit (between 10 and 14 weeks gestation) and again at 20 weeks gestation

Awards & highlights

Study Summary

This trial will test a new game to help educate people about prenatal genetic screening and whether it is more effective than current methods.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves education methods rather than medical treatments, there are no direct physical side effects expected from participating in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am less than 15 weeks pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (between 6 and 12 weeks gestation), after clinic visit (between 10 and 14 weeks gestation) and at 20 weeks gestation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (between 6 and 12 weeks gestation), after clinic visit (between 10 and 14 weeks gestation) and at 20 weeks gestation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (between 6 and 12 weeks gestation), after clinic visit (between 10 and 14 weeks gestation) and at 20 weeks gestation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Prenatal Screening Knowledge

Secondary outcome measures

Change in Decisional Conflict

Shared Decision Making

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Meaning of Screening

2016

N/A

~80

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Erin RothwellLead Sponsor

1 Previous Clinical Trials

5,980 Total Patients Enrolled

National Human Genome Research Institute (NHGRI)NIH

263 Previous Clinical Trials

283,007 Total Patients Enrolled

Erin Rothwell, PhDPrincipal InvestigatorUniversity of Utah

2 Previous Clinical Trials

790 Total Patients Enrolled

Media Library

Genetic Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT05360095 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join the clinical trial at this stage?

"According to clinicaltrials.gov, this particular medical study is no longer enlisting participants. The trial was initially listed on January 1st 2023 and last amended on October 28th 2022. However, there are presently 102 other trials that are currently recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Game Facilitated Interactivity to Genetic Counseling for Prenatal Screening Education

Erin Rothwell 2023. "Comparing Game Facilitated Interactivity to Genetic Counseling for Prenatal Screening Education". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05360095.