Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
1 other identifier
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2015
Longer than P75 for phase_1
1 active site
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
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 25, 2015
CompletedFirst Posted
Study publicly available on registry
November 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedNovember 9, 2023
November 1, 2023
5.7 years
November 25, 2015
November 7, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of social gaze aversion recorded during the social challenge
3 days
Heart rate recorded during the social challenge
3 days
Total t-score on the Social Responsiveness Scale (SRS)
4 weeks
Secondary Outcomes (2)
Verbal responses and pauses in conversation observed during the social challenge
3 days
Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex
3 days
Study Arms (2)
Social gaze training
EXPERIMENTALAppropriate social gaze behavior will be reinforced using the principles of Applied Behavior Analysis.
No Training
NO INTERVENTIONAppropriate social gaze behavior will not be reinforced.
Interventions
Appropriate social gaze behavior will be shaped using the principles of Applied Behavior Analysis.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (1)
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.
PMID: 30153790DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 25, 2015
First Posted
November 30, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
November 9, 2023
Record last verified: 2023-11