Clinical trial NCT05480605: Characterizing Occupational Therapy Intervention for Children With Autism Spectrum Disorders
Official title: Characterizing Occupational Therapy Intervention for Children With Autism Spectrum
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism Spectrum Disorder
Keywords: Occupational Therapy
Engagement
Autism Spectrum Disorders
EEG/ERP
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: American Occupational Therapy Foundation
name: Nationwide Children's Hospital
First posted: 2022-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: EEG: Changes in Sensory Gating event-related potential (ERP) measures.
timeFrame: 8 weeks
measure: EEG: Changes in Sensory Gating neural oscillations
timeFrame: 8 weeks
measure: EEG: Changes in Sensory Registration event-related potential (ERP)
timeFrame: 8 weeks
measure: Changes in behavioral measure of Social Responsiveness
timeFrame: 8 weeks
measure: Changes in behavioral measure of Sensory Processing
timeFrame: 8 weeks
measure: Changes in behavioral measure of Attention
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in Behavioral measures of executive functioning
timeFrame: 8 weeks
measure: Changes in behavioral measure of Adaptive behavior
timeFrame: 8 weeks
measure: Changes in behavioral measures of Anxiety
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: McCampbell Hall
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jewel Crasta, PhD., OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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
citation: 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.
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.
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.
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.