NCT03423160Active, not recruiting
A Novel Framework for Impaired Imitation in ASD
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 201 (actual)
- First submitted
- 24 Jan 2018
- Start date
- 24 Apr 2018
- Primary completion date
- 1 Sept 2023
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Diseases
- Autism
- NCT number
- NCT03423160
What you commit to
- Study type: Observational
- Participants enrolled: 201
- From 24 Apr 2018 to the primary completion date, 1 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 8 years to 12 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kennedy Krieger Institute Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.