Characterizing Occupational Therapy Intervention for Children With Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

Official title:

Characterizing Occupational Therapy Intervention for Children With Autism Spectrum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480605
• Other study ID #: 2021H0140
• Status: Recruiting
• Start date: April 19, 2022
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: Jewel Crasta, PhD., OTR/L
• Phone: 6146850819
• Email: neurolab[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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.

Locations

Country	Name	City	State
United States	McCampbell Hall	Columbus	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	American Occupational Therapy Foundation, Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	8 weeks
Secondary	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.	8 weeks
Secondary	Changes in behavioral measures of Anxiety	The Children's Anxiety Scale (SCAS) is a parent-report measure of anxiety.	8 weeks