Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT03423160
Eligibility Criteria:
General Inclusion Criteria:
Age 8 years, 0 months to 12 years, 11 months, 30 days
Informed consent is provided by a parent or guardian and assent is provided by the child
Wechsler Intelligence Scale for Children-IV (WISC-IV) Full Scale Intelligence Quotient (IQ) \> than 80, unless there is a 12 point or greater index discrepancy, in which case either the Verbal Comprehension Index or Perceptual Reasoning Index must be \> 80 and the lower of the two must be \> 65
Right-handedness, based on the Physical and Neurological Examination for Subtle Signs (PANESS) and Edinburgh Handedness Inventory.
General Exclusion Criteria:
Presence or history of a definitive neurologic disorder including seizures (except for uncomplicated brief febrile seizures), tumor, severe head injury, stroke, lesion, history of skull surgery or disease (because it affects electroencephalogram \[EEG\] analysis) or history of significant EEG abnormality
Presence of a severe chronic medical disorder
Presence of a significant visual impairment (corrected vision at distance worse than 20/40)
History of alcohol/substance abuse or dependency
Excessive tactile sensitivity of the scalp
Contact sensitivity to skin care products or cosmetics (due to possibility for irritation from the EEG electrodes/paste)
Hair styles that would interfere with contact between the EEG cap and the scalp and cannot be removed
Chronic tics or other significant movement disorders
Pregnancy (because of potential and unknown effects on brain function with respect to the measures of this study).
Children will be excluded if they are in foster care. Parents may be the biological or adoptive parent as long as they are the child's legal guardian.
Parents of children in the study may not have a diagnosis of autism.
Additional eligibility criteria for each group are contained in the following sections:
Specific Inclusion/Exclusion Criteria for ASD Group:
Diagnosis of autism spectrum disorder (ASD) will be made conservatively using either the Autism Diagnostic Interview-Revised (ADI-R), or the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2). If circumstances dictate that an ADOS-2 cannot be administered, the Brief Observation of Symptoms of Autism (BOSA) will be administered in its place. The ADOS-2 or BOSA will be performed by a psychology associate trained in its administration and scoring. Children must meet diagnostic thresholds on these instruments, and the diagnosis will be confirmed using Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), by a neurologist.
Children may not have a history of known etiology for autism (e.g., fragile X syndrome, Tuberous Sclerosis, phenylketonuria, congenital rubella) or history of documented prenatal/perinatal insult, and they will show no evidence of meeting criteria for additional psychiatric diagnoses including major depression, bipolar disorder, conduct disorder, or adjustment disorder, based on maternal and child responses from the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS). Subjects with comorbid anxiety disorders, including generalized anxiety disorder, separation anxiety disorder, simple and social phobias, and obsessive-compulsive disorder (OCD), will be allowed to participate since anxiety is common in ASD, and similar repetitive repertoires resembling "obsessive-compulsive behavior" are components of the diagnostic criteria for ASD.
Children with a comorbid diagnosis of attention-deficit/hyperactivity disorder (ADHD) will also be included due to the frequent rates of comorbidity with ASD. Children on stimulant medication will have the medication held on the day of testing.
Specific Inclusion/Exclusion Criteria for Typically Developing (TD) Controls
Children will be included in the typically developing (TD) control group if they: (1) Do not meet published cutoff criteria for ASD on the Social Responsiveness Scale, second edition (SRS-2), (2) do not have a history of a developmental disorder or a psychiatric disorder based on maternal and child responses from the K-SADS (excluding simple or social phobia); and (3) are free of immediate family members (sibling, parent) with autism or other pervasive developmental disorder.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
12 Years
Study:
NCT03423160
Study Brief:
Protocol Section:
NCT03423160