Characterizing Occupational Therapy Intervention for Children With Autism Spectrum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- EEG: Changes in Sensory Gating neural oscillations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
EEG: Changes in Sensory Gating neural oscillations
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
时间窗: 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.
次要结局
- Changes in behavioral measures of Anxiety(8 weeks)
- Changes in behavioral measure of Adaptive behavior(8 weeks)
- Changes in Behavioral measures of executive functioning(8 weeks)
研究者
Jewel Crasta
Assistant Professor
Ohio State University