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

• Sponsor: Stanford University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02616796
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 68
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fragile X Syndrome; Intellectual Disability	Behavioral: Social gaze training	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• Official Title: Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
• Study Start Date: Apr 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Percentage of social gaze aversion recorded during the social challenge [3 days]

2. Heart rate recorded during the social challenge [3 days]

3. Total t-score on the Social Responsiveness Scale (SRS) [4 weeks]

Secondary Outcome Measures

1. Verbal responses and pauses in conversation observed during the social challenge [3 days]

2. Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex [3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 18 Years
• Sexes Eligible for Study: Male
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Social skills training for Fragile X

Publications

None provided.

• Responsible Party: Scott Hall, Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT02616796
• Other Study ID Numbers: 31648
• First Posted: Nov 30, 2015
• Last Update Posted: May 1, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intellectual Disability; Fragile X Syndrome; Syndrome

Study Results

No Results Posted as of May 1, 2019