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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Fragile X Syndrome (FXS)
Interventions Other: Paper and Pencil Informed Consent
Other: Digital Informed Consent Tool
Enrollment 152
Recruitment Details Participants were recruited through research registries and convenience samples
Pre-assignment Details 41 participants were excluded because they did not meet eligibility criteria
Arm/Group Title Intervention Condition Comparison Condition
Hide Arm/Group Description Digital informed consent tool Paper and pencil informed consent
Period Title: Overall Study
Started 55 56
Completed 44 45
Not Completed 11 11
Reason Not Completed
Lost to Follow-up             9             11
Protocol Violation             1             0
Withdrawal by Subject             1             0
Arm/Group Title Intervention Condition Comparison Condition Total
Hide Arm/Group Description Digital informed consent tool Paper and pencil informed consent Total of all reporting groups
Overall Number of Baseline Participants 44 45 89
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 45 participants 89 participants
<=18 years
17
  38.6%
18
  40.0%
35
  39.3%
Between 18 and 65 years
27
  61.4%
27
  60.0%
54
  60.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 45 participants 89 participants
21.16  (7.11) 21.27  (7.50) 21.21  (7.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 45 participants 89 participants
Female
27
  61.4%
25
  55.6%
52
  58.4%
Male
17
  38.6%
20
  44.4%
37
  41.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 45 participants 89 participants
Hispanic or Latino
1
   2.3%
1
   2.2%
2
   2.2%
Not Hispanic or Latino
43
  97.7%
44
  97.8%
87
  97.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 45 participants 89 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   2.2%
1
   1.1%
Black or African American
1
   2.3%
2
   4.4%
3
   3.4%
White
38
  86.4%
40
  88.9%
78
  87.6%
More than one race
2
   4.5%
0
   0.0%
2
   2.2%
Unknown or Not Reported
3
   6.8%
2
   4.4%
5
   5.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants 45 participants 89 participants
44 45 89
Stanford Binet 5 verbal IQ (intelligence quotient) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 44 participants 45 participants 89 participants
65.67  (17.26) 69.48  (16.37) 68.2  (17.8)
[1]
Measure Description: The verbal IQ score of the Stanford Binet 5 provides a composite of all the cognitive skills required to solve the items in the five verbal subtests: fluid reasoning, knowledge, quantitative reasoning, visual-spatial processing, and working memory. The verbal IQ subtests are summed but because individuals with intellectual and developmental disabilities have floor effects on many standardized tests, a z-transformation was used (see Sansone et al. 2014). Unit of measure is the z-transformed verbal IQ score. The range was 40.49 to 110.64 in this sample. A higher score indicates higher verbal IQ.
1.Primary Outcome
Title Decisional Capacity - Understanding Score
Hide Description 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.
Time Frame Day 1, immediately following presentation of the material in the intervention or comparison condition
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Condition Comparison Condition
Hide Arm/Group Description:
Digital informed consent tool
Paper and pencil informed consent
Overall Number of Participants Analyzed 44 45
Mean (Standard Deviation)
Unit of Measure: percentage of understanding
74.4  (27.3) 75.1  (25.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Condition, Comparison Condition
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Time Frame Day 1, immediately following the presentation of the material in the intervention or comparison condition.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Condition Comparison Condition
Hide Arm/Group Description Digital informed consent tool Paper and pencil informed consent
All-Cause Mortality
Intervention Condition Comparison Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/45 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Condition Comparison Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Condition Comparison Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/45 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Don Bailey
Organization: RTI International
Phone: (919) 541-6488
Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT02465931     History of Changes
Other Study ID Numbers: FXS
1R01HD071987-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 22, 2015
First Posted: June 9, 2015
Results First Submitted: November 12, 2018
Results First Posted: December 6, 2018
Last Update Posted: March 7, 2019