Fragile X Syndrome (FXS) Clinical Trial
Official title:
Decisional Capacity and Informed Consent in Fragile X Syndrome
Verified date | February 2019 |
Source | RTI International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 152 |
Est. completion date | March 21, 2017 |
Est. primary completion date | March 21, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Places in the first 3 categories of the MacCAT flip chart - Can provide informed consent using a standard practice Exclusion Criteria: - Not in the first 3 categories of the MacCAT flipchart - Not able to provide informed consent without significant modifications to consent procedures |
Country | Name | City | State |
---|---|---|---|
United States | RTI International | Research Triangle Park | North Carolina |
Lead Sponsor | Collaborator |
---|---|
RTI International | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decisional Capacity - Understanding Score | MacArthur Decisional Capacity - understanding score, range 0 (no understanding) to 26 (perfect understanding) A summary score was calculated, ranging from 0-26. Scores were then translated into a percentage based on the number of questions answered. A score of 100% indicates that the participant answered each understanding question correctly on the first attempt. | Day 1, immediately following presentation of the material in the intervention or comparison condition |
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