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NCT01875640 · ClinicalTrials.gov registry record
Decision Support for Parents Receiving Information About Child's Rare Disease
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 63
- Enrollment target
NCT01875640: Completed study, sponsored by University of Michigan.
NCT01875640 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 63 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01875640 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 63 participants
- Enrollment target
Study Summary
The birth of a child with a disorder of sex development (DSD) is stressful for parents and members of the healthcare team. The "right" decisions about gender assignment (is it a boy? a girl?) and the best course of action (e.g., should there be surgery? what kind? when?) are not obvious. While there have been large advances in diagnostic assessments like genetic and endocrine testing, the tests do not always show what caused the DSD. And, even when the tests do reveal an explanation for the DSD, knowing what happened genetically or hormonally does not usually lead to a single "correct" treatment plan. Instead, it is likely that there are different acceptable treatment options - and parents will need to make decisions based, in part, on their personal preferences, values, and cultural background. Adding more stress to the situation is knowledge that many of the decisions that need to be made by parents early in a child's life are irreversible and exert life-long consequences for the child and the family. To support parents becoming actively involved in making such decisions, and to reduce the likelihood of future worry and regret about decisions that have been made, the investigators will create a decision support tool (DST). The DST will help educate families about typical and atypical sex development of the body, the process by which DSD are diagnosed (especially how to interpret genetic test results), and possible relationships between diagnostic/genetic testing, decisions about care, and known consequences of those decisions on their child and entire family. The DST will be used by parents of young children together with their child's health care provider. The investigators will bring together a network of researchers, health care providers, representatives of patient support and advocacy organizations, and parents of children with DSD to share their experiences. Participants of this network will be involved at each stage of creating the DST, revising it, and p
Primary Outcome
To assess characteristics of communications between parents/caregivers of young children with DSD and the children's healthcare providers by audio-recording standard-of-care appointments at DSD clinic.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-06 |
| Est. Completion | 2017-12 |
What the finished NCT01875640 record still lists
NCT01875640 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 63 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01875640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01875640 about?
NCT01875640 is a clinical study titled "Decision Support for Parents Receiving Information About Child's Rare Disease". The birth of a child with a disorder of sex development (DSD) is stressful for parents and members of the healthcare team. The "right" decisions about gender assignment (is it a boy? a girl?) and the best course of action (e.g., should there be surgery? what kind? when?) are not obvious. While there...
What is the current status of trial NCT01875640?
This trial is currently completed. The enrollment target is 63 participants. The study started on 2013-06. Estimated completion is 2017-12.
Who is sponsoring clinical trial NCT01875640?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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