NCT06246487已完成不适用
Assessing Heterogeneity of Treatment Response in Children With Autism Spectrum Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Neuroimaging
研究概览
简要总结
Greater than 80% of children with autism spectrum disorder (ASD) experience sensory differences that make it difficult for them to fully participate in meaningful everyday activities. In this research study, we will use MRI and behavioral methods to assess how sensory interventions might change sensory brain structures, allowing us to better predict which sensory interventions might work best for whom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male children 6 years, 0 months to 8 years, 6 months of age with a diagnosis of autism spectrum disorder (ASD) will qualify for inclusion. Our inclusion age ensures all study participants will complete intervention/control conditions and be retested before they turn 9 years of age. Additional inclusion criteria include:
- •The families of children will have access to transportation to attend intervention sessions 2 times per week for 16-weeks.
- •Children who qualify will be verbal, and will speak and understand English. The native language of caregivers can include Spanish.
- •Children who qualify will have sensorimotor delays as assessed by the study team using the standardized, norm-referenced assessments described in this research proposal (z-scores on 3 of 5 tests -1.0 or lower).
排除标准
- •Children younger than 6 years of age or older than 8 years, 6 months of age will be excluded. Additional exclusion criteria include:
- •Female children
- •Auditory hyperresponsivity as assessed during screening procedures.
- •Medical co-morbidities such as extreme prematurity (less than 28 weeks), blindness, deafness, cerebral palsy, Down Syndrome, tuberous sclerosis, or head-injury with loss of consciousness.
- •History of individual occupational therapy services in a clinical setting that includes sensory equipment.
- •Non-removable metal in the head or body (e.g. dental fillings & braces, metal pins, screws or plates).
- •Children unable to complete neurocognitive or sensorimotor testing.
- •Children unsuccessful in 3 mock scanning sessions during baseline testing.
结局指标
主要结局
Neuroimaging
时间窗: 16 weeks
Pre vs, post magnetic resonance imaging scans
次要结局
未报告次要终点
研究者
研究点 (2)
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