Decision Support for Parents Receiving Information About Child's Rare Disease
This trial is active, not recruiting.
|Conditions||disorder of sex development, intersex conditions, congenital adrenal hyperplasia, hypospadias|
|Treatment||decision support tool|
|Sponsor||University of Michigan|
|Collaborator||Patient-Centered Outcomes Research Institute|
|Start date||June 2013|
|End date||May 2016|
|Trial size||45 participants|
|Trial identifier||NCT01875640, 13-PAF00134, 1360, HUM72007|
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 putting it into practice. At the end of this project, the investigators will have a fully formed and tested DST that will be available for parents to use with their child's health care team as they are first learning their child may have a DSD.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Los Angeles, CA||University of California Los Angeles||no longer recruiting|
|Ann Arbor, MI||University of Michigan||no longer recruiting|
|Philadelphia, PA||Temple University||no longer recruiting|
|Seattle, WA||Seattle Children's Hospital||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Primary purpose||health services research|
Qualitative Assessment of Focus Groups, Usual Care and DST Implementation
time frame: 2.5 years
Male or female participants up to 6 years old.
- Must be a parent/caregiver of a patient who is newborn through 5 years old (i.e., 5.9 yrs).
- Patient clinical diagnosis of ambiguous genitalia (eg, 46,XX,Prader 2+; proximal hypospadias with uni/bilateral undescended testes) or sex chromosomes discordant with genital phenotype.
- Condition must be newly ascertained. No surgical procedures (internal or external genitalia) have been performed or other decisions made (excluding those driven by medical urgency) regarding diagnostic testing or clinical management.
- Turner syndrome, Klinefelter syndrome, bladder or cloacal exstrophy.
|Official title||Decision Support for Parents Receiving Information About Child's Rare Disease|
|Principal investigator||David E Sandberg, PhD|
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