Phase
Condition
Williams Syndrome
Asperger's Disorder
Treatment
N/AClinical Study ID
Ages 3-5 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For All Subjects:
Children (regardless of biological sex) Age 3 - 5. Participants must be able tocomplete the study before turning 6.
Written parental permission will be obtained prior to any study procedures. Childverbal assent will be obtained.
IQ 60-150 (ASD) and 80-150 (TD) as assessed by the Differential Ability Scales - 2ndEdition or developmental level via Mullen Scales of Early Learning Composite (ELC).
Participant and parent/guardian must be English speaking.
For ASD Participants (only):
Diagnosis of ASD based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the BOSA or Autism Diagnostic Observation Schedule (ADOS-2) and short form (ADI-R) scored age appropriately. Diagnostic evaluations will be completed byresearch staff and supervised by a licensed psychologist.
If parents are biological, a minimum of the child and one parent will be required toconsent to the blood draw procedure. It is preferred that the child and bothbiological parents participate in the blood draw procedure. The inability to obtainblood samples will not be exclusionary.
Exclusion
Exclusion Criteria:
For All Subjects:
Known genetic or neurological syndrome with an established link to autism (inaddition to ASD for ASD participants)
This does not include events in which the link to ASD is less wellknown/established (e.g., 16p11.2 CNVs, CHD8 mutations, Trisomy 21, 22q deletionsyndrome, Dup 15q Syndrome).
Specific cases will be discussed with the clinical team who will make a finaldetermination, as needed.
History of epilepsy or seizure disorder a. This does not include history of simple febrile seizures or if the child isseizure free (regardless of the seizure type) for the past year.
Motor or sensory impairment that would interfere with the valid completion of studymeasures including significant hearing or vision impairment not correctable by ahearing aid or glasses/contact lenses. Children who wear bifocal or progressivelenses are not eligible.
Children who are taking neurological or psychiatric medications that are not stableon prescription or dose for 8 weeks prior to D1. a. Medication is not exclusionary. Children taking neurological or psychiatricmedications, including anti epileptics and psychopharmacological agents, must bestable on the medication and dose for 8 weeks prior to D1.
History of significant prenatal/perinatal/birth injury as defined by birth <36 weeksAND weight <2000 grams (approximately 4.5.lbs).
History of neonatal brain damage. (e.g., with diagnosed hypoxic or ischemic event).
Any other factor that the investigator feels would make assessment or measurementperformance invalid.
For ASD Participants (only):
- Any known environmental circumstances that is likely to account for the picture ofautism in the proband (severe nutritional or psychological deprivation etc.)
For TD Participants (only):
Known historical diagnosis of ASD or a sibling with ASD.
Criteria score in the ASD range on the BOSA/ADOS
Active psychiatric disorder (depression, anxiety, ADHD, etc.) and/or any currenttreatment (medication or other treatment) for a psychiatric condition.
Participants will be screened using the (ECI-5 or CSI-4). Due to theinstrument's high sensitivity and potential for false positives, any score inthe clinical range will be reviewed by research staff for determination ofeligibility.
Study Design
Study Description
Connect with a study center
Children's Hospital Los Angeles
Los Angeles, California 90027
United StatesActive - Recruiting
Yale Child Study Center
New Haven, Connecticut 06510
United StatesActive - Recruiting
Boston Children's Hospital
Boston, Massachusetts 02445
United StatesActive - Recruiting
Duke University
Durham, North Carolina 27708
United StatesActive - Recruiting
University of Washington
Seattle, Washington 98195
United StatesActive - Recruiting
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