Back to resultsEffects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
Primary Purpose
Fragile X Syndrome, Intellectual Disability
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Social gaze training
Sponsored by
About this trial
This is an interventional treatment trial for Fragile X Syndrome
Eligibility Criteria
Inclusion Criteria:
- Boys diagnosed with fragile X syndrome
- Boys with intellectual disability who do not have FXS or other known genetic disorder associated with intellectual disability
- Age 8 to 18 years inclusive
- Ability to travel to Stanford
- Vineland Adaptive Behavior Scales standard score between 50 and 75 points
Exclusion Criteria:
- Sensory impairments, or any other serious medical or neurological condition that affects growth or development (e.g., seizure disorder, diabetes, congenital heart disease).
- Materials in body that would preclude an MRI scan (e.g., dental braces).
Sites / Locations
- Stanford University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Social gaze training
No Training
Arm Description
Appropriate social gaze behavior will be reinforced using the principles of Applied Behavior Analysis.
Appropriate social gaze behavior will not be reinforced.
Outcomes
Primary Outcome Measures
Percentage of social gaze aversion recorded during the social challenge
Heart rate recorded during the social challenge
Total t-score on the Social Responsiveness Scale (SRS)
Secondary Outcome Measures
Verbal responses and pauses in conversation observed during the social challenge
Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02616796
Brief Title
Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
Official Title
Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fragile X Syndrome, Intellectual Disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Social gaze training
Arm Type
Experimental
Arm Description
Appropriate social gaze behavior will be reinforced using the principles of Applied Behavior Analysis.
Arm Title
No Training
Arm Type
No Intervention
Arm Description
Appropriate social gaze behavior will not be reinforced.
Intervention Type
Behavioral
Intervention Name(s)
Social gaze training
Intervention Description
Appropriate social gaze behavior will be shaped using the principles of Applied Behavior Analysis.
Primary Outcome Measure Information:
Title
Percentage of social gaze aversion recorded during the social challenge
Time Frame
3 days
Title
Heart rate recorded during the social challenge
Time Frame
3 days
Title
Total t-score on the Social Responsiveness Scale (SRS)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Verbal responses and pauses in conversation observed during the social challenge
Time Frame
3 days
Title
Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex
Time Frame
3 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Boys diagnosed with fragile X syndrome
Boys with intellectual disability who do not have FXS or other known genetic disorder associated with intellectual disability
Age 8 to 18 years inclusive
Ability to travel to Stanford
Vineland Adaptive Behavior Scales standard score between 50 and 75 points
Exclusion Criteria:
Sensory impairments, or any other serious medical or neurological condition that affects growth or development (e.g., seizure disorder, diabetes, congenital heart disease).
Materials in body that would preclude an MRI scan (e.g., dental braces).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott S Hall, PhD
Phone
650-498-4799
Email
hallss@stanford.edu
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott S Hall, PhD
Phone
650-498-4799
Email
hallss@stanford.edu
First Name & Middle Initial & Last Name & Degree
Scott S Hall, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
30153790
Citation
Gannon CE, Britton TC, Wilkinson EH, Hall SS. Improving social gaze behavior in fragile X syndrome using a behavioral skills training approach: a proof of concept study. J Neurodev Disord. 2018 Aug 28;10(1):25. doi: 10.1186/s11689-018-9243-z.
Results Reference
derived
Learn more about this trial
Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
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