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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02616796
Other study ID # 31648
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date April 2015
Est. completion date December 2020

Study information

Verified date November 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving social gaze behavior in children with fragile X syndrome (FXS). The investigators will use the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills. Importantly, the investigators propose to examine the effects of this treatment probe on brain and behavior.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender Male
Age group 8 Years to 18 Years
Eligibility Inclusion Criteria: 1. Boys diagnosed with fragile X syndrome 2. Boys with intellectual disability who do not have FXS or other known genetic disorder associated with intellectual disability 3. Age 8 to 18 years inclusive 4. Ability to travel to Stanford 5. Vineland Adaptive Behavior Scales standard score between 50 and 75 points Exclusion Criteria: 1. Sensory impairments, or any other serious medical or neurological condition that affects growth or development (e.g., seizure disorder, diabetes, congenital heart disease). 2. Materials in body that would preclude an MRI scan (e.g., dental braces).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Social gaze training
Appropriate social gaze behavior will be shaped using the principles of Applied Behavior Analysis.

Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of social gaze aversion recorded during the social challenge 3 days
Primary Heart rate recorded during the social challenge 3 days
Primary Total t-score on the Social Responsiveness Scale (SRS) 4 weeks
Secondary Verbal responses and pauses in conversation observed during the social challenge 3 days
Secondary Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex 3 days
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