Characterizing Occupational Therapy Intervention for Children With Autism Spectrum Disorders

NCT05480605 | Completed

• 1 other identifier: 2021H0140
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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.

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

Secondary Outcomes (3)

• Changes in Behavioral measures of executive functioning

  8 weeks

• Changes in behavioral measure of Adaptive behavior

  8 weeks

• Changes in behavioral measures of Anxiety

  8 weeks

Study Arms (1)

Experimental Group

Children with autism ages 6-13

Behavioral: Occupational Therapy

Interventions

Occupational Therapy BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• American Occupational Therapy Foundation: collaborator
• Nationwide Children's Hospital: collaborator

Study Sites (2)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

McCampbell Hall

Columbus, Ohio, 43210, United States

Location

Related Publications (6)

• 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.

  PMID: 24477447 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23101741 BACKGROUND

• 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.

  PMID: 31225588 BACKGROUND

• 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.

  PMID: 17436834 BACKGROUND

• 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.

  PMID: 33310588 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Jewel Crasta, PhD., OTR/L

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: July 29, 2022
• Study Start: April 19, 2022
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: November 14, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be released at the end of the study and accessible upon request.
• Access Criteria: IPD will be accessible upon request to the study PI.

Locations

US (2)