Clinical Trial: Decision Support for Parents Receiving Information About Child's Rare Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Decision Support for Parents Receiving Information About Child's Rare Disease

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 (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 organizatio

Detailed Summary:
Sponsor: University of Michigan

Current Primary Outcome: Qualitative Assessment of Focus Groups, Usual Care and DST Implementation [ Time Frame: 2.5 years ]

To assess characteristics of communications during focus groups and between health care providers and parents before and during the implementation of the DST audiofiles will be coded and analyzed using SCCAP (Siminoff Communication Content & Affect Program). SCCAP© is a new computerized coding scheme used to facilitate, organize, and code health communication data. It is designed so that coders can code directly from audio recordings, allowing the coder to take advantage of the vocalic cues inherent in speech intonations. Transcriptions can also be uploaded and coded so specific text can be viewed and tagged for future use.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Michigan

Dates:
Date Received: May 30, 2013
Date Started: June 2013
Date Completion: December 2017
Last Updated: June 29, 2016
Last Verified: June 2016