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

Phase 1

Completed

• Conditions: Intellectual Disability; Fragile X Syndrome
• Interventions: Behavioral: Social gaze training

• Registration Number: NCT02616796
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-11-27
• Study First Posted: 2015-11-30
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 71

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Social gaze training	Social gaze training	Appropriate social gaze behavior will be reinforced using the principles of Applied Behavior Analysis.

Primary Outcome Measures

Name	Time	Method
Percentage of social gaze aversion recorded during the social challenge	3 days
Total t-score on the Social Responsiveness Scale (SRS)	4 weeks
Heart rate recorded during the social challenge	3 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States