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Characterizing Occupational Therapy Intervention for Children With Autism Spectrum Disorders

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The Ohio State University

Status

Enrolling

Conditions

Autism Spectrum Disorder

Treatments

Behavioral: Occupational Therapy

Study type

Observational

Funder types

Other

Identifiers

NCT05480605
2021H0140

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

6 to 13 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

Experimental Group
Description:
Children with autism ages 6-13
Treatment:
Behavioral: Occupational Therapy
Control Group
Description:
Typically developing children ages 6-13

Trial contacts and locations

2

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Central trial contact

Jewel Crasta, PhD., OTR/L

Data sourced from clinicaltrials.gov

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