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Decisional Capacity and Informed Consent in Fragile X Syndrome

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ClinicalTrials.gov Identifier: NCT02465931
Recruitment Status : Completed
First Posted : June 9, 2015
Results First Posted : December 6, 2018
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
RTI International

Tracking Information
First Submitted Date  ICMJE May 22, 2015
First Posted Date  ICMJE June 9, 2015
Results First Submitted Date  ICMJE November 12, 2018
Results First Posted Date  ICMJE December 6, 2018
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE March 14, 2016
Actual Primary Completion Date March 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
Decisional Capacity - Understanding Score [ Time Frame: Day 1, immediately following presentation of the material in the intervention or comparison condition ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
Decisional capacity assessment [ Time Frame: Up to 12 months ]
This will only include individuals who took part in the Aim 1 assessments. The sample size will be approximately 75 or more; however, eligibility and travel will play a role in how many we can feasibly conduct. Siblings will be eligible to participate so long as testing is done separately. The Aim 1 team members will provide an estimate of decisional capacity based on an individual's performance on the MacCAT flip chart and in consideration of the other assessments. Those in the first 3 categories will be eligible for the randomized control trial but those in the fourth category will not.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decisional Capacity and Informed Consent in Fragile X Syndrome
Official Title  ICMJE Decisional Capacity and Informed Consent in Fragile X Syndrome
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Fragile X Syndrome (FXS)
Intervention  ICMJE
  • Other: Paper and Pencil Informed Consent
    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.
  • Other: Digital Informed Consent Tool
    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.
Study Arms  ICMJE
  • Comparison Condition
    Paper and pencil informed consent
    Intervention: Other: Paper and Pencil Informed Consent
  • Experimental: Intervention condition
    Digital informed consent tool
    Intervention: Other: Digital Informed Consent Tool
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2019)
152
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2015)
200
Actual Study Completion Date  ICMJE March 21, 2017
Actual Primary Completion Date March 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02465931
Other Study ID Numbers  ICMJE FXS
1R01HD071987-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party RTI International
Original Responsible Party Same as current
Current Study Sponsor  ICMJE RTI International
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Study Director: Robert Furberg, PhD RTI International
PRS Account RTI International
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP