Characterizing Occupational Therapy Intervention for Children With Autism Spectrum Disorders

Recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: Occupational Therapy

• Registration Number: NCT05480605
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study First Submitted: 2022-04-18
• Study Start: 2022-04-19
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Group	Occupational Therapy	Children with autism ages 6-13

Primary Outcome Measures

Name	Time	Method
EEG: Changes in Sensory Gating neural oscillations	8 weeks	Evoked and phase-locked Beta power (13-18 Hz) and Gamma power (30-50 Hz) following click onset will be examined.
Changes in behavioral measure of Social Responsiveness	8 weeks	The 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 Processing	8 weeks	The Sensory Profile - 2 (SP2) is a standardized parent-report measure and will be used to measure sensory processing.
Changes in behavioral measure of Attention	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.
EEG: Changes in Sensory Registration event-related potential (ERP)	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.
EEG: Changes in Sensory Gating event-related potential (ERP) measures.	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.

Secondary Outcome Measures

Name	Time	Method
Changes in behavioral measures of Anxiety	8 weeks	The Children's Anxiety Scale (SCAS) is a parent-report measure of anxiety.
Changes in behavioral measure of Adaptive behavior	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.
Changes in Behavioral measures of executive functioning	8 weeks	The Behavior Rating Inventory of Executive Function-2 (BRIEF-2) is a standardized parent-report measure of executive functioning.

Trial Locations

Locations (2)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

McCampbell Hall; 🇺🇸 Columbus, Ohio, United States