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Autism Spectrum DisorderNCT05480605

Characterizing Occupational Therapy Intervention for Children With Autism Spectrum Disorders

An observational study of Autism Spectrum Disorder, run by Ohio State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot study aims to identify behavioral and neural measures of sensory processing and attention associated with routine occupational therapy intervention for children with autism spectrum disorders. Read more about this study

Who is it for?
Ages 6 to 13 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Occupational Therapy
How many people
2 participants
Where
2 sitesUnited States
Study dates
19 Apr 2022to 4 Nov 2024
Phase
Observational
Are there results?
None posted in the registry

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 6 to 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children ages 6-13 years diagnosed with Autism with an IQ > 65, and age-matched typically developing children.

Who may be able to join

  • For children with autism:
  • a medical diagnosis of Autism
  • between 8 - 13 years
  • must be verbal
  • have normal or corrected vision/hearing
  • enrollment in the 8-week OT treatment plan with a therapist enrolled in the study.
  • For typically developing children:
  • No history of neurological injuries, disabilities, and family history of mental health disorders on parent report

Who cannot join

  • history of a definitive neurologic disorder including seizures (except for uncomplicated brief febrile seizures), tumor, severe head injury, stroke, lesion, or disease
  • presence of a severe chronic medical disorder
  • presence of a major visual impairment
  • history of alcohol/substance abuse or dependency.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • McCampbell Hall

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Characterizing Occupational Therapy Intervention for Children With Autism Spectrum

This pilot study aims to identify behavioral and neural measures of sensory processing and attention associated with routine occupational therapy intervention for children with autism spectrum disorders. Specifically, the investigator will examine the impact of a child's level of engagement during therapy using standardized behavioral and electroencephalography (EEG) measures of sensory processing.

Read the detailed description

Occupational therapy is one of the most frequently requested and highly utilized interventions for children with autism spectrum disorders (autism) and therapists have consistently reported using the sensory integration framework as a dominant theory guiding practice. A key component of sensory integration theory is the child's active engagement during therapy, which is assumed to improve neural function, behavior, and participation. However, no studies have examined the neural mechanisms associated with occupational therapy interventions among children with autism.

This pilot feasibility study will examine behavioral and electroencephalography (EEG) measures of attention and sensory processing before and following 6-8 weeks of routine occupational therapy at community outpatient centers among 30 children with autism aged 6 - 13 years. The primary aim is to determine the feasibility, sensitivity, and validity of EEG measures of auditory processing as a response biomarker following routine occupational therapy intervention. Another aim is to examine the contribution of a child's engagement during therapy as a key predictor of change using behavioral and EEG outcome measures. The occupational therapy intervention consists of one-hour weekly sessions of usual care at Nationwide Children's Hospital outpatient centers.

Results from this grant will provide valuable proof-of-concept data establishing engagement during therapy as an active ingredient in occupational therapy intervention using neurophysiological and behavioral measures. These results will also establish the validity of EEG measures as sensitive to a child's level of engagement and neuroplastic changes following occupational therapy intervention.

Being tested
Occupational Therapy
Keywords
Occupational Therapy, Engagement, Autism Spectrum Disorders, EEG/ERP
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.

  • Occupational TherapyBehavioural

    Children with autism will receive 6 - 8 weeks of regularly scheduled occupational therapy at Nationwide Children's Hospital outpatient centers. The intervention consists of one-hour weekly sessions with a licensed occupational therapist.

Study groups in NCT05480605
Study groupRoleWhat they receive
Experimental GroupChildren with autism ages 6-13
Receives: Behavioral: Occupational Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EEG: Changes in Sensory Gating event-related potential (ERP) measures.

    Amplitudes and latencies of the P50 and N1 ERP components from the sensory gating paradigm. The P50 component presents as a positive deflection that occurs around 40-80 milliseconds (ms) after click onset and the N1 represents a negative deflection occurring around 100 ms. Gating will be assessed using difference scores wherein the amplitude of click 2 is subtracted from the amplitude of click 1.

    Measured: 8 weeks

  2. EEG: Changes in Sensory Gating neural oscillations

    Evoked and phase-locked Beta power (13-18 Hz) and Gamma power (30-50 Hz) following click onset will be examined.

    Measured: 8 weeks

  3. EEG: Changes in Sensory Registration event-related potential (ERP)

    The Sensory Registration paradigm consists of four tones of different frequencies and intensities. Amplitude and latency of the P1, N1, P2, N2, and P3 ERP measures following the four tones of the sensory registration paradigm will be examined.

    Measured: 8 weeks

  4. Changes in behavioral measure of Social Responsiveness

    The Sensory Responsiveness scale - 2 (SRS-2) is a standardized parent-report measure and will be used to measure social responsiveness.

    Measured: 8 weeks

  5. Changes in behavioral measure of Sensory Processing

    The Sensory Profile - 2 (SP2) is a standardized parent-report measure and will be used to measure sensory processing.

    Measured: 8 weeks

  6. Changes in behavioral measure of Attention

    The Test of Everyday Attention for Children 2 (TEA-Ch2) will be used to measure attention. The TEACh2 is a standardized performance-based measure.

    Measured: 8 weeks

Secondary outcomes (3)

  1. Changes in Behavioral measures of executive functioning

    The Behavior Rating Inventory of Executive Function-2 (BRIEF-2) is a standardized parent-report measure of executive functioning.

    Measured: 8 weeks

  2. Changes in behavioral measure of Adaptive behavior

    The Vineland Adaptive Behavior Scales-3 (VABS-3) is a standardized parent-report measure of adaptive behavior and is widely used in autism research.

    Measured: 8 weeks

  3. Changes in behavioral measures of Anxiety

    The Children's Anxiety Scale (SCAS) is a parent-report measure of anxiety.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2022
  2. Study start19 Apr 2022
  3. Primary completion4 Nov 2024
  4. Study completion4 Nov 2024

Resources

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
Cohort
Time perspective
Prospective
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05480605
Sponsor's protocol ID
2021H0140
Status last verified
Nov 2024
First submitted
18 Apr 2022
Last updated
14 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Case-Smith J, Weaver LL, Fristad MA. A systematic review of sensory processing interventions for children with autism spectrum disorders. Autism. 2015 Feb;19(2):133-48. doi: 10.1177/1362361313517762. Epub 2014 Jan 29.

    PubMed 24477447

  • Crasta, J. E. (2018). Behavioral and neural sensory processing in young adults with autism spectrum disorder. American Journal of Occupational Therapy, 72(4_Supplement_1), 7211505081p1. https://doi.org/10.5014/ajot.2018.72S1-PO1012

  • Dawson G, Jones EJ, Merkle K, Venema K, Lowy R, Faja S, Kamara D, Murias M, Greenson J, Winter J, Smith M, Rogers SJ, Webb SJ. Early behavioral intervention is associated with normalized brain activity in young children with autism. J Am Acad Child Adolesc Psychiatry. 2012 Nov;51(11):1150-9. doi: 10.1016/j.jaac.2012.08.018.

    PubMed 23101741

  • LaGasse AB, Manning RCB, Crasta JE, Gavin WJ, Davies PL. Assessing the Impact of Music Therapy on Sensory Gating and Attention in Children With Autism: A Pilot and Feasibility Study. J Music Ther. 2019 Aug 13;56(3):287-314. doi: 10.1093/jmt/thz008.

    PubMed 31225588

  • Miller LJ, Anzalone ME, Lane SJ, Cermak SA, Osten ET. Concept evolution in sensory integration: a proposed nosology for diagnosis. Am J Occup Ther. 2007 Mar-Apr;61(2):135-40. doi: 10.5014/ajot.61.2.135. No abstract available.

    PubMed 17436834

  • Crasta JE, Gavin WJ, Davies PL. Expanding our understanding of sensory gating in children with autism spectrum disorders. Clin Neurophysiol. 2021 Jan;132(1):180-190. doi: 10.1016/j.clinph.2020.09.020. Epub 2020 Oct 16.

    PubMed 33310588

Questions about this trial

What is this clinical trial studying?

An observational study of Autism Spectrum Disorder, run by Ohio State University at 2 sites 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?

The sponsor lists 8 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

EEG: Changes in Sensory Gating event-related potential (ERP) measures. (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05480605, which also lists 6 linked publications.

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 14 Nov 2025.

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