A Novel Framework for Impaired Imitation in ASD

NCT03423160 | Active Not Recruiting

• 1 other identifier: IRB00146732
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

There is long-standing recognition that people with autism spectrum disorders (ASD) have difficulty imitating others' actions; some investigators have highlighted impaired imitation as being a core contributor to the development of autism. What is yet unknown is precisely how imitation in children with ASD differs from that of typically developing peers.The investigators have identified a task parameter that separates preserved from impaired gesture imitation in ASD: children with ASD have difficulty imitating when the task requires two separate movement elements be coordinated simultaneously. By contrast, imitation is relatively preserved when movement elements are performed serially. The coordination of simultaneous movements is a hallmark of actions performed in the real world. With an eye to optimizing common therapies that depend heavily on imitation, the next step is to tease apart where, in the chain from perception to action, the capacity limitation in simultaneous processing lies. This study will be conducted in about two days and will involve imitating gestures that are presented via video. In addition, an EEG will record the brain's electrical activity during certain tasks to assess how the brain responds when the imitation task is more or less difficult. Several other clinical and behavioral measures will also be used.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Psychophysical measures of imitation

  2-3 purpose-designed psychophysical measures of gesture imitation ability and its sub-components

  Day 1 or 2

Secondary Outcomes (1)

• EEG measures of brain activity during gesture imitation

  Day 1 or 2

Study Arms (2)

Autism

Right-handed children, ages 8.0-12.9, diagnosed with high-functioning ASD (and no co-morbid conditions, excluding anxiety disorders)

Other: None--observational

Control

Right-handed children, ages 8.0-12.9, with no neurological or psychiatric diagnoses, currently or by history

Other: None--observational

Interventions

None--observational OTHER

Observational study of behavior and electrical brain activity

Autism; Control

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

See above

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Joshua Ewen, MD

  Hugo Moser Research Institute at Kennedy Krieger

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 6, 2018
• Study Start: April 24, 2018
• Primary Completion: September 1, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: As required

Locations

US (1)