Characterizing Occupational Therapy Intervention for Children With Autism Spectrum Disorders

November 13, 2025 updated by: Jewel Crasta, Ohio State University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
      • Columbus, Ohio, United States, 43210
        • McCampbell Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental Group
Children with autism ages 6-13
Behavioral: Occupational Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG: Changes in Sensory Gating event-related potential (ERP) measures.
Time Frame: 8 weeks
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.
8 weeks
EEG: Changes in Sensory Gating neural oscillations
Time Frame: 8 weeks
Evoked and phase-locked Beta power (13-18 Hz) and Gamma power (30-50 Hz) following click onset will be examined.
8 weeks
EEG: Changes in Sensory Registration event-related potential (ERP)
Time Frame: 8 weeks
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.
8 weeks
Changes in behavioral measure of Social Responsiveness
Time Frame: 8 weeks
The Sensory Responsiveness scale - 2 (SRS-2) is a standardized parent-report measure and will be used to measure social responsiveness.
8 weeks
Changes in behavioral measure of Sensory Processing
Time Frame: 8 weeks
The Sensory Profile - 2 (SP2) is a standardized parent-report measure and will be used to measure sensory processing.
8 weeks
Changes in behavioral measure of Attention
Time Frame: 8 weeks
The Test of Everyday Attention for Children 2 (TEA-Ch2) will be used to measure attention. The TEACh2 is a standardized performance-based measure.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Behavioral measures of executive functioning
Time Frame: 8 weeks
The Behavior Rating Inventory of Executive Function-2 (BRIEF-2) is a standardized parent-report measure of executive functioning.
8 weeks
Changes in behavioral measure of Adaptive behavior
Time Frame: 8 weeks
The Vineland Adaptive Behavior Scales-3 (VABS-3) is a standardized parent-report measure of adaptive behavior and is widely used in autism research.
8 weeks
Changes in behavioral measures of Anxiety
Time Frame: 8 weeks
The Children's Anxiety Scale (SCAS) is a parent-report measure of anxiety.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

Nationwide Children's Hospital
American Occupational Therapy Foundation

Investigators

  • Principal Investigator: Jewel Crasta, PhD., OTR/L, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2022

Primary Completion (Actual)

November 4, 2024

Study Completion (Actual)

November 4, 2024

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

July 27, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021H0140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

IPD will be released at the end of the study and accessible upon request.

IPD Sharing Access Criteria

IPD will be accessible upon request to the study PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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