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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 weeks
Treatment ~ Varies
Follow Up ~from collection of specimen through 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from collection of specimen through 3 months for reporting.

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

Genetic Counselor (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03842995 — N/A
Whole Genome Sequencing Research Study Groups: Genetic Counselor, Trained Healthcare Provider
Whole Genome Sequencing Clinical Trial 2023: Genetic Counselor Highlights & Side Effects. Trial Name: NCT03842995 — N/A
Genetic Counselor (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03842995 — N/A

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
~135 spots leftby Mar 2025