NCT01204151

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

4.8 years

First QC Date

September 15, 2010

Last Update Submit

May 7, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent correct

    2 days

Study Arms (1)

Math intervention

EXPERIMENTAL
Behavioral: discrete-trial training

Interventions

Math intervention

Eligibility Criteria

Age10 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • (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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Developmental DisabilitiesFragile X Syndrome

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersX-Linked Intellectual DisabilityIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSex Chromosome DisordersChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornGenetic Diseases, X-LinkedHeredodegenerative Disorders, Nervous System

Study Officials

  • Scott Hall

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 17, 2010

Study Start

September 1, 2008

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

May 9, 2019

Record last verified: 2019-05

Locations