N/A N=111 Randomized Screening

Decisional Capacity and Informed Consent in Fragile X Syndrome

Fragile X Syndrome (FXS)

Bottom Line

View on ClinicalTrials.gov: NCT02465931 ↗

Enrolled (actual)

111

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcome: Primary: Decisional Capacity - Understanding Score — 74.4; 75.1 percentage of understanding — p=0.89

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Paper and Pencil Informed Consent (Other); Digital Informed Consent Tool (Other)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: RTI International
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Decisional Capacity - Understanding Score	74.4; 75.1	0.89

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02465931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.