Your session is about to expire
← Back to Search
Behavioral Intervention
DNA Sequencing Results Delivery for Newborn Genetic Screening
N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from collection of specimen through 3 months
Awards & highlights
Study Summary
This trial will test whether providing parents of infants with genetic disorder results from whole genome sequencing (WGS) through a web portal by non-genetics providers is as effective as providing results from genetic counselors.
Who is the study for?
This trial is for parents or guardians of newborns in NICU with signs of a genetic disorder, particularly from African-American and rural backgrounds. Participants must be willing to engage with surveys but cannot require language interpreter services.Check my eligibility
What is being tested?
The study tests how well technology-assisted delivery of whole genome sequencing (WGS) results by regular healthcare providers compares to traditional delivery by genetic counselors, using web-based materials tailored for cultural relevance.See study design
What are the potential side effects?
There are no direct medical side effects as this trial involves information delivery rather than medication. However, receiving genetic information can have emotional or psychological impacts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from collection of specimen through 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from collection of specimen through 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate parental empowerment using the Genetic Counseling Outcome Scale (GCOS)
Secondary outcome measures
Evaluate parental uncertainties using the Parental Perceptions of Uncertainties in Genomic Sequencing (PUGS)
Evaluate personal utility using the Parental Personal Utility Scale (PrU)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Trained Healthcare ProviderExperimental Treatment1 Intervention
Healthcare providers (e.g., neonatologists and neonatology nurse practitioners) will receive training to competently deliver Whole Genome Sequencing results to parents/caregivers of neonates enrolled in SouthSeq
Group II: Genetic CounselorPlacebo Group1 Intervention
Standard of Care. Parents/caregivers of neonates enrolled in SouthSeq will receive counseling on their child's Whole Genome Sequencing (WGS) results from Genetic Counselors
Find a Location
Who is running the clinical trial?
HudsonAlpha Institute for BiotechnologyUNKNOWN
2 Previous Clinical Trials
527 Total Patients Enrolled
Children's Hospital of New OrleansUNKNOWN
Norton's Children's HospitalUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My whole genome sequencing shows secondary findings.
Research Study Groups:
This trial has the following groups:- Group 1: Genetic Counselor
- Group 2: Trained Healthcare Provider
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals currently being enrolled in this scientific experiment?
"The entry on clinicaltrials.gov reveals that this study is currently recruiting patients, and was first posted in April 15th 2019 with the last update occuring November 21st 2022."
Answered by AI
What is the current capacity of this experiment?
"The clinical trial requires 800 patients who meet the designated criteria to take part. These individuals will have access to sites like University of Mississippi Medical Center in Jackson and Woman's Hospital in Baton Rouge, Louisiana."
Answered by AI
Share this study with friends
Copy Link
Messenger