Ignite Creation Date:
2024-05-06 @ 1:42 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01875640
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2013-05-30
Brief Title:
Decision Support for Parents Receiving Information About Childs Rare Disease
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Decision Support for Parents Receiving Information About Childs Rare Disease
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DSD DST
Brief 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 eg 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 childs 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 diagnosticgenetic 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 childs 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 putting it into practice At the end of this project the investigators will have a fully formed DST that will be available for parents to use with their childs healthcare team as they are first learning their child may have a DSD
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 diagnosticgenetic 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 childs 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 putting it into practice At the end of this project the investigators will have a fully formed DST that will be available for parents to use with their childs healthcare team as they are first learning their child may have a DSD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HUM72007 | OTHER | University of Michigan | None |
| 13-PAF00134 | OTHER | None | None |