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

Stanford University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Fragile X Syndrome; Intellectual Disability

Treatments: Behavioral: Social gaze training

Study type: Interventional

Funder types: Other

Identifiers

NCT02616796

31648 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: Male

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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71 participants in 2 patient groups

Social gaze training

Experimental group

Description:

Appropriate social gaze behavior will be reinforced using the principles of Applied Behavior Analysis.

Treatment:

Behavioral: Social gaze training

No Training

No Intervention group

Description:

Appropriate social gaze behavior will not be reinforced.