NCT03459651

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
4.1 years until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2022

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

1 day

First QC Date

February 27, 2018

Last Update Submit

May 3, 2022

Conditions

Keywords

numeracynumber sense

Outcome Measures

Primary Outcomes (2)

  • Single and multiple-operand addition and subtraction accuracy

    Task accuracy calculated as the percentage of trials answered correctly.

    8 weeks

  • Single and multiple-operand addition and subtraction response time

    Average amount of time, in seconds, required to answer each question on the task.

    8 weeks

Study Arms (1)

ANS training

EXPERIMENTAL
Behavioral: ANS training

Interventions

ANS trainingBEHAVIORAL

In-home computer-based ANS training

ANS training

Eligibility Criteria

Age6 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children, adolescents, and adult women with Turner syndrome.
  • Healthy controls.
  • Normal or corrected to normal vision.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Interdisciplinary Brain Sciences Research

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Turner Syndrome

Condition Hierarchy (Ancestors)

Gonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSex Chromosome DisordersChromosome DisordersGenetic Diseases, InbornGonadal DisordersEndocrine System Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 9, 2018

Study Start

April 1, 2022

Primary Completion

April 2, 2022

Study Completion

April 2, 2022

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations