Back to resultsTeaching Math Skills to Individuals With Fragile X Syndrome
Primary Purpose
Developmental Disabilities, Fragile X Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
discrete-trial training
Sponsored by
About this trial
This is an interventional supportive care trial for Developmental Disabilities
Eligibility Criteria
Inclusion Criteria:
- (a) 10 to 23 years of age (this age range was chosen to maximize the probability that subjects will cooperate with the imaging procedures as well as benefit from the interventions),
- (b) in good physical health,
- (c) able to participate in the imaging component of the project,
- (d) IQ between 50 and 80. We have found that individuals with IQ's less than 50 points are generally unable to comply with the scanning procedures.
- (e) diagnosis of FXS (for FXS group) and non-specific developmental disorder (for control group).
Exclusion Criteria:
Exclusion criteria include
- contraindications for MRI (e.g., pacemaker, braces),
- the presence of neurological or sensory problems not associated with the conditions of interest (e.g., head trauma, blindness), or inability to discontinue psychotropic medication for 4 weeks prior to the scan.
- Additional exclusion criteria for the control group include the presence of any known identifiable syndrome (e.g., fragile X syndrome, Down syndrome, Prader-Willi syndrome, Turner syndrome, PKU, fetal alcohol syndrome, Williams syndrome).
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Math intervention
Arm Description
Outcomes
Primary Outcome Measures
Percent correct
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01204151
Brief Title
Teaching Math Skills to Individuals With Fragile X Syndrome
Official Title
Evaluating a Brief Intensive Intervention for Individuals With Fragile X Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
Children with FXS are predisposed to manifesting a particular profile of intellectual strengths and weaknesses, including specific deficits in math, visual-spatial skills, executive functioning, and social skills. Until now, intensive behavioral interventions have not been targeted to syndrome-specific weaknesses. In the present study we will develop and evaluate behavioral strategies to aid skill acquisition in children with FXS.
Detailed Description
There are no experimental data of skill acquisition using matching-to-sample techniques (or any other specific cognitive intervention) conducted with individuals with FXS. Further, no studies have been conducted to examine the possible underlying or mediating brain processes involved during matching-to-sample skill acquisition in children with FXS or any other neurodevelopmental disorder.
Previous pilot data have indicated that the computerized match-to-sample procedure, even when conducted in time-limited sessions, may significantly help individuals with FXS learn new skills. We plan to utilize brain imaging methodology to compare functional connectivity networks for those who pass and those who fail the equivalence test. 30 subjects with FXS and 30 control subjects with idiopathic developmental disability will be enrolled in the study. All subjects will be enrolled at Stanford.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Disabilities, Fragile X Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Math intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
discrete-trial training
Primary Outcome Measure Information:
Title
Percent correct
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(a) 10 to 23 years of age (this age range was chosen to maximize the probability that subjects will cooperate with the imaging procedures as well as benefit from the interventions),
(b) in good physical health,
(c) able to participate in the imaging component of the project,
(d) IQ between 50 and 80. We have found that individuals with IQ's less than 50 points are generally unable to comply with the scanning procedures.
(e) diagnosis of FXS (for FXS group) and non-specific developmental disorder (for control group).
Exclusion Criteria:
Exclusion criteria include
contraindications for MRI (e.g., pacemaker, braces),
the presence of neurological or sensory problems not associated with the conditions of interest (e.g., head trauma, blindness), or inability to discontinue psychotropic medication for 4 weeks prior to the scan.
Additional exclusion criteria for the control group include the presence of any known identifiable syndrome (e.g., fragile X syndrome, Down syndrome, Prader-Willi syndrome, Turner syndrome, PKU, fetal alcohol syndrome, Williams syndrome).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Hall
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
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Teaching Math Skills to Individuals With Fragile X Syndrome
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