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Characterizing Occupational Therapy Intervention for Children With Autism Spectrum Disorders

Characterizing Occupational Therapy Intervention for Children With Autism Spectrum

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05480605
Enrollment
2
Registered
2022-07-29
Start date
2022-04-19
Completion date
2024-11-04
Last updated
2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Occupational Therapy, Engagement, Autism Spectrum Disorders, EEG/ERP

Brief 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. 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.

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.

Interventions

BEHAVIORALOccupational 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.

Sponsors

American Occupational Therapy Foundation
CollaboratorOTHER
Nationwide Children's Hospital
CollaboratorOTHER
Ohio State University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
EEG: Changes in Sensory Gating neural oscillations8 weeksEvoked and phase-locked Beta power (13-18 Hz) and Gamma power (30-50 Hz) following click onset will be examined.
EEG: Changes in Sensory Gating event-related potential (ERP) measures.8 weeksAmplitudes 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.
EEG: Changes in Sensory Registration event-related potential (ERP)8 weeksThe 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.
Changes in behavioral measure of Social Responsiveness8 weeksThe Sensory Responsiveness scale - 2 (SRS-2) is a standardized parent-report measure and will be used to measure social responsiveness.
Changes in behavioral measure of Sensory Processing8 weeksThe Sensory Profile - 2 (SP2) is a standardized parent-report measure and will be used to measure sensory processing.
Changes in behavioral measure of Attention8 weeksThe Test of Everyday Attention for Children 2 (TEA-Ch2) will be used to measure attention. The TEACh2 is a standardized performance-based measure.

Secondary

MeasureTime frameDescription
Changes in Behavioral measures of executive functioning8 weeksThe Behavior Rating Inventory of Executive Function-2 (BRIEF-2) is a standardized parent-report measure of executive functioning.
Changes in behavioral measure of Adaptive behavior8 weeksThe Vineland Adaptive Behavior Scales-3 (VABS-3) is a standardized parent-report measure of adaptive behavior and is widely used in autism research.
Changes in behavioral measures of Anxiety8 weeksThe Children's Anxiety Scale (SCAS) is a parent-report measure of anxiety.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026