Decisional Capacity and Informed Consent in Fragile X Syndrome

Completed · Not applicable

Conditions studied: Fragile X Syndrome (FXS)

In brief

The Decisional Capacity and Informed Consent in Fragile X Syndrome (FXS) project is for the Eunice Kennedy Shriver National Institute of Child Health \& Human Development, 1R01HD071987-01A1, and will provide the first comprehensive description of decisional capacity of individuals with FXS; identify individual, family, and experiential factors associated with variability in decisional capacity; determine the validity of caregiver and expert ratings; and develop evidence-based guidelines for categorizing decisional capacity of individuals with FXS. The researchers will develop a methodologically rigorous and conceptually grounded decision aid using digital technology to enhance participation of individuals with FXS in the consent process.

Key facts

Study ID

NCT02465931

Run by

RTI International

People needed

152

Starts

2016-03-14

Expected to finish

2017-03-21

Last updated by the study team

2019-03-07

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Places in the first 3 categories of the MacCAT flip chart
• Can provide informed consent using a standard practice

You may not qualify if…

• Not in the first 3 categories of the MacCAT flipchart
• Not able to provide informed consent without significant modifications to consent procedures

Where it is running

• RTI International — Research Triangle Park, North Carolina, United States

Full record on ClinicalTrials.gov

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