Back to resultsEffect of Turner Syndrome on Number Sense
Primary Purpose
Turner Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ANS training
Sponsored by
About this trial
This is an interventional treatment trial for Turner Syndrome focused on measuring numeracy, number sense
Eligibility Criteria
Inclusion Criteria:
- Children, adolescents, and adult women with Turner syndrome.
- Healthy controls.
- Normal or corrected to normal vision.
Exclusion Criteria:
- Major psychiatric or developmental disorder (e.g., bipolar disorder, major depression, psychotic disorders, intellectual disability, autism spectrum disorder).
- Chemical dependency
- Currently taking the following medications: antidepressant, antipsychotic, and anti-seizures drugs.
Sites / Locations
- Center for Interdisciplinary Brain Sciences Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ANS training
Arm Description
Outcomes
Primary Outcome Measures
Single and multiple-operand addition and subtraction accuracy
Task accuracy calculated as the percentage of trials answered correctly.
Single and multiple-operand addition and subtraction response time
Average amount of time, in seconds, required to answer each question on the task.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03459651
Brief Title
Effect of Turner Syndrome on Number Sense
Official Title
Investigation of the Role of Turner Syndrome on Approximate Number Sense
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator elected to end the study.
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 2, 2022 (Actual)
Study Completion Date
April 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates approximate number sense (ANS) in children, adolescents, and adult women with Turner syndrome compared to age-matched healthy peers. One primary aim of this project is to assess the effectiveness of an online ANS training tool in enhancing complex mathematics ability. Participants will undergo weekly training sessions in their own home. Half of the participants will complete 2 training sessions a week for 8 weeks, and the second half will complete 1 training session for 8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Turner Syndrome
Keywords
numeracy, number sense
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ANS training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
ANS training
Intervention Description
In-home computer-based ANS training
Primary Outcome Measure Information:
Title
Single and multiple-operand addition and subtraction accuracy
Description
Task accuracy calculated as the percentage of trials answered correctly.
Time Frame
8 weeks
Title
Single and multiple-operand addition and subtraction response time
Description
Average amount of time, in seconds, required to answer each question on the task.
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children, adolescents, and adult women with Turner syndrome.
Healthy controls.
Normal or corrected to normal vision.
Exclusion Criteria:
Major psychiatric or developmental disorder (e.g., bipolar disorder, major depression, psychotic disorders, intellectual disability, autism spectrum disorder).
Chemical dependency
Currently taking the following medications: antidepressant, antipsychotic, and anti-seizures drugs.
Facility Information:
Facility Name
Center for Interdisciplinary Brain Sciences Research
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified individual participant data for the primary outcome measures may be made available upon reasonable request.
Learn more about this trial
Effect of Turner Syndrome on Number Sense
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