Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Intellectual Disability; Fragile X Syndrome
• Intervention / Treatment: Behavioral: Social gaze training

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Scott S Hall, PhD; Phone Number: 650-498-4799; Email: hallss@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social gaze training; Appropriate social gaze behavior will be reinforced using the principles of Applied Behavior Analysis.	Behavioral: Social gaze training; Appropriate social gaze behavior will be shaped using the principles of Applied Behavior Analysis.
No Intervention: No Training; Appropriate social gaze behavior will not be reinforced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: November 27, 2015
• First Posted (Estimated): November 30, 2015

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Mental Retardation, X-Linked; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Chromosome Disorders; Sex Chromosome Disorders; Syndrome; Fragile X Syndrome; Intellectual Disability
• Other Study ID Numbers: 31648 (WakeForest)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No