Autism Spectrum DisorderNCT03423160
A Novel Framework for Impaired Imitation in ASD
An observational study of Autism Spectrum Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- None--observational
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2018to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: See above
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21205
About this study
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.
Read the detailed description
Visuo-motor imitation (VMI) impairments are central to the pathogenesis and affect the treatment of autism spectrum disorders (ASD). Therapies most commonly used to enhance social, communicative, academic, adaptive and occupational function in individuals with ASD rely on imitation, and impairments in VMI represent a bottleneck to the efficiency and efficacy of these therapies. Furthermore, an influential psychological account suggests that imitation impairments lead to the development of the ASD phenotype. By studying precisely how VMI is impaired in ASD, it is possible both to enhance widespread therapies and possibly to alter the course of the disorder itself. Unfortunately, researchers currently know little about the precise nature of imitation impairments in ASD. Our laboratory has recently identified a promising specific 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. This finding has been subsequently validated in a published study and again replicated in preliminary data. Coordination of simultaneous movements is a hallmark of skills performed in the real world (shoe tying, eating with knife-and-fork, driving, communicating with simultaneous verbal and gestural language). In order to optimize common adaptive and social-communicative skill therapies, the next step is to tease apart where, in the chain from perception to action, the capacity limitation in simultaneous processing lies. To do this, the investigators propose a rigorous research plan that encompasses three complementary experimental approaches: systematic psychophysics, neuropsychological testing and EEG. The goal is to specifically dissect the contribution to the simultaneity bottleneck in perceptual vs. motor processes using psychophysical control experiments. Under the hypothesis that some children with ASD may have more perceptual limitations and others may have more motor limitations, the investigators will assess heterogeneity explicitly. It is then possible to relate perceptual and motor aspects of simultaneous gesture VMI to validated neuropsychological tests of known clinical attentional and perceptual deficits in ASD. Finally, in Aim 3, the investigators will directly interrogate visual and motor networks. EEG measures of task-related activation are sensitive to task load and can be differentially assessed in visual and motor networks. By assessing deficient event-related modulation of EEG activity in visual or motor networks to simultaneous (high-load) vs. serial (low-load) conditions, the investigators can pinpoint the bottleneck. In addition to providing an approach that is complementary to the behavioral measures of Aims 1 and 2, the results of the EEG study can pave the way for future biomarkers and neurostimulation therapies.
- Conditions
- Autism Spectrum Disorder
- Being tested
- None--observational
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None--observationalOther
Observational study of behavior and electrical brain activity
| Study group | Role | What they receive |
|---|---|---|
| Autism | Right-handed children, ages 8.0-12.9, diagnosed with high-functioning ASD (and no co-morbid conditions, excluding anxiety disorders) Receives: Other: None--observational | |
| Control | Right-handed children, ages 8.0-12.9, with no neurological or psychiatric diagnoses, currently or by history Receives: Other: None--observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychophysical measures of imitation
2-3 purpose-designed psychophysical measures of gesture imitation ability and its sub-components
Measured: Day 1 or 2
Secondary outcomes (1)
EEG measures of brain activity during gesture imitation
Event-related spectral perturbation associated with imitation task (and control tasks), at sites reflecting the activity of visuo-motor networks
Measured: Day 1 or 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start24 Apr 2018
- Primary completion1 Sep 2023
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ericka Wodka, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Joshua Ewen, MD, Principal investigator, Hugo Moser Research Institute at Kennedy Krieger
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423160
- Sponsor's protocol ID
- IRB00146732
- Status last verified
- Apr 2026
- First submitted
- 24 Jan 2018
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Submission of de-identified EEG data to the National Institutes of Mental Health Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Framework for Impaired Imitation in ASD
- ClinicalTrials.gov ID
- NCT03423160
- Acronym / sponsor ID
- IRB00146732
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Visuo-motor imitation (VMI) impairments are central to the pathogenesis and affect the treatment of autism spectrum disorders (ASD). Therapies most commonly used to enhance social, communicative, academic, adaptive and occupational function in individuals with ASD rely on imitation, and impairments in VMI represent a bottleneck to the efficiency and efficacy of these therapies. Furthermore, an influential psychological account suggests that imitation impairments lead to the development of the ASD phenotype. By studying precisely how VMI is impaired in ASD, it is possible both to enhance widespread therapies and possibly to alter the course of the disorder itself. Unfortunately, researchers currently know little about the precise nature of imitation impairments in ASD. Our laboratory has recently identified a promising specific 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. This finding has been subsequently validated in a published study and again replicated in preliminary data. Coordination of simultaneous movements is a hallmark of skills performed in the real world (shoe tying, eating with knife-and-fork, driving, communicating with simultaneous verbal and gestural language). In order to optimize common adaptive and social-communicative skill therapies, the next step is to tease apart where, in the chain from perception to action, the capacity limitation in simultaneous processing lies. To do this, the investigators propose a rigorous research plan that encompasses three complementary experimental approaches: systematic psychophysics, neuropsychological testing and EEG. The goal is to specifically dissect the contribution to the simultaneity bottleneck in perceptual vs. motor processes using psychophysical control experiments. Under the hypothesis that some children with ASD may have more perceptual limitations and others may have more motor limitations, the investigators will assess heterogeneity explicitly. It is then possible to relate perceptual and motor aspects of simultaneous gesture VMI to validated neuropsychological tests of known clinical attentional and perceptual deficits in ASD. Finally, in Aim 3, the investigators will directly interrogate visual and motor networks. EEG measures of task-related activation are sensitive to task load and can be differentially assessed in visual and motor networks. By assessing deficient event-related modulation of EEG activity in visual or motor networks to simultaneous (high-load) vs. serial (low-load) conditions, the investigators can pinpoint the bottleneck. In addition to providing an approach that is complementary to the behavioral measures of Aims 1 and 2, the results of the EEG study can pave the way for future biomarkers and neurostimulation therapies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism | – | Other: None--observationalRight-handed children, ages 8.0-12.9, diagnosed with high-functioning ASD (and no co-morbid conditions, excluding anxiety disorders) |
| Control | – | Other: None--observationalRight-handed children, ages 8.0-12.9, with no neurological or psychiatric diagnoses, currently or by history |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- See above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None--observationalObservational study of behavior and electrical brain activity | Other | Autism, Control |
Primary outcome
Psychophysical measures of imitation
Time frame: Day 1 or 2
2-3 purpose-designed psychophysical measures of gesture imitation ability and its sub-components
1 secondary outcome
EEG measures of brain activity during gesture imitation
Time frame: Day 1 or 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes. Submission of de-identified EEG data to the National Institutes of Mental Health Data Archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Ewen, MD principal investigator
Hugo Moser Research Institute at Kennedy Krieger
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychophysical measures of imitation (time frame: Day 1 or 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.