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NCT02465931 · ClinicalTrials.gov registry record · NA
Decisional Capacity and Informed Consent in Fragile X Syndrome
A NA study, sponsored by RTI International.
- Completed
- Registry status
- NA
- Development phase
- 152
- Enrollment target
NCT02465931: Completed NA study, sponsored by RTI International.
NCT02465931 is a NA study that has completed, run by RTI International. The registered enrollment target is 152 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02465931, a NA study, has completed, sponsored by RTI International.
- COMPLETED
- Registry status
- NA
- Development phase
- 152 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- OTHER Paper and Pencil Informed Consent
- OTHER Digital Informed Consent Tool
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2016-03-14 |
| Est. Completion | 2017-03-21 |
| Phase | NA |
What the finished NCT02465931 record still lists
NCT02465931 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Paper and Pencil Informed Consent is the first listed.
NCT02465931 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02465931 about?
NCT02465931 is a clinical study titled "Decisional Capacity and Informed Consent in Fragile X Syndrome". 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...
What is the current status of trial NCT02465931?
This trial is currently completed. It is a NA study. The enrollment target is 152 participants. The study started on 2016-03-14. Estimated completion is 2017-03-21.
What interventions are being tested in trial NCT02465931?
The interventions under investigation include: Paper and Pencil Informed Consent (OTHER), Digital Informed Consent Tool (OTHER).
Who is sponsoring clinical trial NCT02465931?
This trial is sponsored by RTI International, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02465931's enrollment target sits among peer trials
152 658th of 2000 higher than 1,340 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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