Actively Recruiting
Improving Parental Support in Hypospadias Care
Led by University of North Carolina, Chapel Hill · Updated on 2025-12-17
324
Participants Needed
2
Research Sites
70 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating ways to improve support for parents of children with hypospadias, a condition affecting the penis. This study will enroll parent-child pairs and aims to better understand and enhance the care experience for families managing hypospadias. The study will last 36 months, with each participant pair involved for at least 6 months. Parents will be randomly assigned to access one of two educational websites about hypospadias: one developed by the study team with enhanced content, and one basic educational site. Before their child's first pediatric urologist consultation, parents will complete surveys about their knowledge and comfort with healthcare information. After reviewing the assigned website, they will complete a pre-consultation survey. The child may have one or two urology visits, which may be audio recorded with permission. If the child is found not to have hypospadias, the family may complete one final phone call and exit the study. Throughout the study, parents will complete post-consultation surveys about knowledge, care management, and treatment decisions. Further follow-up will include phone interviews about website use and a final survey about 6 months after the treatment decision. Researchers will measure outcomes like knowledge scores, decisional conflict, and decisional regret. The study includes monitoring clinic visit durations and will maintain participant confidentiality throughout the follow-up period.
CONDITIONS
Brief Title
Improving Parental Support in Hypospadias Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent is 18 years old or older
- Parent is fluent and literate in English or Spanish
- Parent or legal guardian of the child
- Ability to provide consent
- Only one eligible parent per child
- Plan to attend a urology consultation
- Access to a smartphone, tablet, or computer with reliable internet
- Ability and agreement to receive unencrypted communications by text or email
- Child is 0 to 5 years old at time of urology consultation
- Child has an upcoming urology consult with an enrolled pediatric urologist regarding hypospadias
You will not qualify if you...
- Parent previously participated in a hypospadias study
- Parent has another child with hypospadias or the father has known hypospadias history
- Parent is unaware of any penile abnormality in the child
- A final hypospadias treatment decision has already been made with a pediatric urologist
- Investigator discretion excludes the parent
- Child had prior hypospadias surgery
- Child has a urology consult scheduled less than one week from identification
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to assess eligibility and obtain consent
Duration - Up to 7 days before the first consultation
Parents receive access to one of two educational websites about hypospadias and complete surveys about their knowledge and comfort before the child's urology consultation.
1 to 2 visits or contacts to complete surveys and receive website access
Duration - Within 3 to 60 days after enrollment
The child attends 1 or 2 pediatric urology consultation visits where the condition is evaluated; visits may be audio recorded with permission.
1 to 2 in-person clinic visits
Duration - 1 to 30 days after the final clinic visit
After consultation, parents complete surveys about hypospadias knowledge, care options, and treatment decisions, and may participate in phone calls regarding website experience.
1 to 2 contacts (in-person or phone) for surveys and feedback
Duration - Around 6 months after treatment decision
Approximately 6 months after treatment decision, parents complete a final survey about treatment choices and experiences over time.
1 phone or remote contact
Trial Site Locations
Total: 2 locations
1
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
A
Ariel Lunsford, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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