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CompletedNCT01204151Updated May 9, 2019

Teaching Math Skills to Individuals With Fragile X Syndrome

An interventional study of discrete-trial training in Developmental Disabilities and Fragile X Syndrome, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 10 Years to 23 Years. Per ClinicalTrials.gov, last updated 2019-05-09.

Sponsored by Stanford University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
10 Years to 23 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Developmental Disabilities
  • Fragile X Syndrome
03

In context

Fragile X Syndrome

110 studies on the registry are indexed under Fragile X Syndrome; 23 are open to participants now.

This study's enrollment of 60 is close to the median of 58 across 88 interventional studies indexed under Fragile X Syndrome.

Browse Fragile X Syndrome studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 23 Years
Sexes eligible
All
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).
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Math intervention

    Behavioral: discrete-trial training

Interventions

  • Behavioraldiscrete-trial training
06

What researchers measure

Primary outcomes

  1. Percent correct

    Time frame: 2 days

07

Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01204151
Lead sponsor
Stanford University
Responsible party
Scott Hall (Principal Investigator, Stanford University) — Principal investigator
First posted
Sep 17, 2010
Start date
Sep 2008
Primary completion
Jul 2013
Completion
Jul 2013
Last update
May 9, 2019

Study contacts

Scott Hall
principal investigator · Stanford University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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