- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02465931
Decisional Capacity and Informed Consent in Fragile X Syndrome
February 25, 2019 updated by: RTI International
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
FXS is the most common inherited form of intellectual disability (ID).
The typical male has an IQ (intelligence quotient) of 50 to 55, but involvement ranges from mild to severe.
Females are generally less affected and have a broader range in function.
Some have severe ID and adaptive impairments, but most have a normal or borderline intellectual ability.
This wide range in cognitive skills leads to variable ability to make choices and live independently.
Most research on individuals with FXS has been noninvasive, limited to parent surveys and psychological assessments.
Studies such as these evoke few if any major ethical concerns, so the consent process typically involves a straightforward parental consent.
Some studies have drawn blood, collected saliva, measured heart rate, or used neuroimaging, but until recently there has been a paucity of treatment research.
This scenario has changed dramatically in the past several years.
Advances in understanding the molecular basis of FXS have led to a new generation of treatments, and clinical trials are under way using a variety of compounds.
The possibility of side effects and the potential for significant changes in behavior and ability elevate to a new level the importance of obtaining meaningful consent, not only from parents, but also from individuals with FXS.
Researchers and Institutional Review Board (IRB) members need data to guide decisions about involving individuals with FXS in the consent process.
Unfortunately, little is known about the extent to which individuals with FXS can be or are involved in decisions about research participation.
This project will assess the range of decisional capacity in FXS, identify factors associated with individual differences in decisional capacity, validate a rating scale for categorizing decisional capacity, and develop a novel tablet-based decision aid technology to assist researchers and clinicians in maximizing decisional capacity and consent.
This study will work toward achieving two overarching aims: 1) Characterize and explain individual differences in decisional capacity in FXS, 2) Design and evaluate the effect of a tablet-based decision aid on participation in the consent process for a hypothetical clinical trial.
Ultimately, this study will provide important information about the nature of decisional capacity in FXS and validate a novel intervention to maximize successful participation in the consent process.
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Research Triangle Park, North Carolina, United States, 27709
- RTI International
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 38 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Comparison Condition
Paper and pencil informed consent
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Paper-based informed consent form will be sent to participant and family before data collection visit.
They will be able to review as many times as they wish before visit.
During visits, simplified overview of informed consent form will be provided in person just once.
For MacArthur Competence Assessment Tool (MacCAT) Questions, All questions will be asked after the disclosure information has been presented.
Questions will have the same wording as experimental condition.
Procedures will mimic MacCAT/flipchart (incorrect or partial credit will be given opportunity to answer question again after disclosure information is repeated).
There will be multiple choice options rather than open-ended.
Finally, data collection will be done through paper and pencil.
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Experimental: Intervention condition
Digital informed consent tool
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Paper informed consent form will be sent to participant and family before data collection visit.
They will be able to review as many times as they wish before visit.
During visits, the participant can go through the tablet-based tool up to 3 times.
All questions will be embedded within the vignettes/presentation of disclosure information.
Question will use simplified wording, similar to flipchart.
Procedures will mimic MacArthur Competence Assessment Tool (MacCAT) /flipchart (incorrect or partial credit will be given opportunity to answer question again after disclosure information is repeated).
Multiple choice options will be utilized rather than open-ended.
Finally, response data stored within tool and exported to dataset for analysis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decisional Capacity - Understanding Score
Time Frame: Day 1, immediately following presentation of the material in the intervention or comparison condition
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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.
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Day 1, immediately following presentation of the material in the intervention or comparison condition
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Robert Furberg, PhD, RTI International
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Furberg RD, Raspa M, Wheeler AC, McCormack LA, Bailey DB. A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Nov 19;7(11):e10360. doi: 10.2196/10360.
- Furberg RD, Ortiz AM, Moultrie RR, Raspa M, Wheeler AC, McCormack LA, Bailey DB Jr. A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development. JMIR Res Protoc. 2018 Jun 6;7(6):e10525. doi: 10.2196/10525.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2016
Primary Completion (Actual)
March 21, 2017
Study Completion (Actual)
March 21, 2017
Study Registration Dates
First Submitted
May 22, 2015
First Submitted That Met QC Criteria
June 4, 2015
First Posted (Estimate)
June 9, 2015
Study Record Updates
Last Update Posted (Actual)
March 7, 2019
Last Update Submitted That Met QC Criteria
February 25, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Mental Retardation, X-Linked
- Intellectual Disability
- Heredodegenerative Disorders, Nervous System
- Chromosome Disorders
- Sex Chromosome Disorders
- Syndrome
- Fragile X Syndrome
Other Study ID Numbers
- FXS
- 1R01HD071987-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fragile X Syndrome (FXS)
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Ovid Therapeutics Inc.CompletedFragile X Syndrome (FXS)United States
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Guido A. Davidzon, MD, SMWithdrawn
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University of California, DavisUniversity of Alberta; St. Justine's HospitalRecruitingNeurobehavioral Manifestations | Genetic Diseases, X-Linked | Intellectual Disability | Fragile X Syndrome | Sex Chromosome Disorders | Fragile X Mental Retardation Syndrome | Trinucleotide Repeat Expansion | Fra(X) Syndrome | FXS | Mental Retardation, X LinkedUnited States, Canada
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University of AlbertaSt. Justine's HospitalRecruitingNeurobehavioral Manifestations | Genetic Diseases, X-Linked | Mental Retardation, X-Linked | Intellectual Disability | Fragile X Syndrome | Sex Chromosome Disorders | Fragile X Mental Retardation Syndrome | Trinucleotide Repeat Expansion | Fra(X) Syndrome | FXSCanada
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Tetra Discovery PartnersCompletedFragile X Syndrome | Fra(X) Syndrome | FXSUnited States
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Stanford UniversityTerminatedFragile X Syndrome (FXS) | Idiopathic Intellectual Developmental Disorder (IDD)United States
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University Hospital, ToursCompletedHealthy Volunteers | Autism | Fragile-X Syndrome (FXS)France
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