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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02616796
Enrollment
71
Registered
2015-11-30
Start date
2015-04-30
Completion date
2020-12-31
Last updated
2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fragile X Syndrome, Intellectual Disability

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.

Interventions

BEHAVIORALSocial gaze training

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

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
MALE
Age
8 Years to 18 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Percentage of social gaze aversion recorded during the social challenge3 days
Heart rate recorded during the social challenge3 days
Total t-score on the Social Responsiveness Scale (SRS)4 weeks

Secondary

MeasureTime frame
Verbal responses and pauses in conversation observed during the social challenge3 days
Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex3 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026