NCT06832280 · University of North Carolina, Chapel Hill
Improving Parental Support in Hypospadias Care
What this study is about
The proposed study will enroll parent-child pairs and is designed to obtain new knowledge and improve hypospadias care. Parent-child pairs will be randomly assigned into different groups over 36 months and participate for at least 6 months.
View original scientific description
The proposed study will enroll parent-child pairs and is designed to obtain new knowledge and improve hypospadias care. Parent-child pairs will be randomized into different groups over 36 months and participate for at least 6 months.
Interventions
OTHER
Educational Website Developed by Study Team
This website was developed by the study team in previous research studies.
OTHER
Basic Educational Website
This website is a basic education website about hypospadias.
Primary outcome measures
Mean primary outcome measure 1 score (to be disclosed after final subject completes T3 data collection)*
Time frame: Post-clinic visit, 1-30 days after the final clinic visit (T3)
Measures primary outcome 1 construct. The total possible range of scores is from 1 to 6, where higher scores indicate more of the primary outcome 1 construct. \*To preserve scientific integrity certain details of the record are not included in the registration and will be added to the record after all primary outcome data have been gathered.
Mean primary outcome measure 2 score among 50% of participants (to be disclosed after final subject completes T3 data collection)**
Time frame: Clinic visit(s), 3-60 days after enrollment (T2a) and up to 12 months after the first clinic visit (T2b). Note some patients will only have T2a.
Clinic visits will be audio recorded and coded using primary outcome measure 2 to measure primary outcome 2 construct. The total possible range of scores is from 0 to 4, where higher scores indicate more of the primary outcome 2 construct. \*\*To preserve scientific integrity certain details of the record are not included in the registration and will be added to the record after all primary outcome data have been gathered.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- A parent must meet all of the following criteria to be included:
- Age ≥ 18 years old
- Fluent and literate in English or Spanish
- Parent or legal guardian
- Ability to consent
- One eligible parent per child
- Plan to attend urology consultation
- Has access to a smart phone, tablet, or computer with reliable internet access
- Has the ability and agrees to receive unencrypted communications by text or email A child must meet all of the following criteria to be included:
- 0-5 years old at the time of urology consultation
- Have an upcoming urology consult with an enrolled pediatric urologist regarding hypospadias
Exclusion criteria
- If a parent meets any of the following criteria they will be excluded:
- Previous participant in hypospadias study
- Parent has another child with hypospadias or father of the child has a known history of hypospadias
- Parent is unaware of any penile abnormality with child
- A final hypospadias treatment decision has been made in discussion with a pediatric urologist
- Investigator discretion If a child meets any of the following criteria they will be excluded:
- Prior hypospadias surgery
- Upcoming hypospadias urology consult is less than five days away from when the patient was identified
Where
- Indianapolis, Indiana
- Chapel Hill, North Carolina
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Indiana University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations