Improving parental support for children with hypospadias

Improving Parental Support in Hypospadias Care

This study is testing whether giving parents different educational resources about hypospadias can help them feel more knowledgeable and comfortable when talking about their child's condition with a doctor.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sex: All
• Sponsor: University of North Carolina, Chapel Hill (other)
• Locations: 2 sites (Indianapolis, Indiana and 1 other locations)
• Trial ID: NCT06832280 on ClinicalTrials.gov

What this trial studies

This study enrolls parent-child pairs to enhance care for children diagnosed with hypospadias by providing them with educational resources. Parents will be randomized to receive one of two educational websites before their child's consultation with a pediatric urologist. The study aims to assess the impact of these resources on parental knowledge and comfort in discussing their child's condition. Data will be collected through surveys and optional audio recordings of consultations over a period of 36 months.

Who should consider this trial

Good fit: Ideal candidates include parents of children aged 0-5 who are referred for a potential diagnosis of hypospadias and can attend a urology consultation.

Not a fit: Patients who may not benefit include those whose parents are not fluent in English or Spanish, or those who have previously participated in a hypospadias study.

Why it matters

Potential benefit: If successful, this study could significantly improve parental understanding and management of hypospadias, leading to better outcomes for their children.

How similar studies have performed: While there is limited data on similar educational interventions specifically for hypospadias, educational approaches in pediatric care have shown promise in improving parental engagement and knowledge.

Eligibility criteria

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 scheduled less than a week away from when the patient was identified

Where this trial is running

Indianapolis, Indiana and 1 other locations

• Indiana University — Indianapolis, Indiana, United States (RECRUITING)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Samantha Schilling, MD, MSHP — UNC Chapel Hill
• Study coordinator: Ariel Lunsford, BA

Conditions: Hypospadias, Pediatric Urologists