Investigating the Mirror Neuron System in Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Change in EEG Frequency Data- Observing actions
研究概览
简要总结
The aim of the study is to determine whether a targeted behavioral intervention can lead to both changes in early communication skills and in neural responses in toddlers and preschoolers with autism.
详细描述
The mirror neuron system (MNS) broadly refers to a network of brain regions that responds both when a person performs an action and when that person observes someone else performing the same action. This system emerges in infancy and develops over time to support more complex social abilities. It has been hypothesized that autism involves fundamental impairments to the MNS, which can explain the deficits in joint attention, imitation, communication and social cognition.
This study investigates the MNS in 100 toddlers and preschoolers recently diagnosed with autism or with a suspected diagnosis of autism. First, children with (suspected) autism complete a battery of behavioral measures and MNS activity will be assessed using electrophysiology (EEG; event-related potentials) while the child participates in specific tasks. Then, the children with (suspected) autism will be randomly assigned to one of two behavioral intervention programs (i.e., targeted joint attention intervention or parent education intervention) that will be carried out by interventionists and parents for 10-12 weeks. At the end of the intervention, these children will be re-evaluated on behavioral tasks and EEG to investigate changes as a result of the intervention.
The investigators hypothesize that the joint attention intervention will lead to significant changes on both the neural and behavioral measures of MNS functioning.
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
- 18 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between the ages of 18 and 59 months with a confirmed or suspected DSM5 diagnosis of autism spectrum disorder
- •The included parents or guardians are required to be the primary caregivers of these children
- •Families must speak English in the home at least 75% of the time.
排除标准
- •Seizure disorder (may influence EEG data)
- •Gestational age <32 weeks
- •History of serious head trauma
- •Genetic syndrome (e.g., fragile X syndrome)
研究组 & 干预措施
Jasper
JASPER (Joint Attention Symbolic Play Engagement Regulation) is a targeted intervention that focusses on early communication skills.
干预措施: Jasper (Behavioral)
Parent Education
Parent education intervention focusses on parenting a child with autism.
干预措施: Parent Education (Behavioral)
结局指标
主要结局
Change in EEG Frequency Data- Observing actions
时间窗: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
EEG frequency data as measured while child observes objects grasped and pointed to by others.
Change in imitation measured with the Elicited Imitation Battery (adapted from Rogers et al., 2003)
时间窗: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
The child is presented with 3 manual actions (e.g., holding palm up), 3 actions on objects. The child's movements will be coded on a 5-point scale from 0 (no movement) to 5 (imitating all the different experimenter actions).
Change in language measured with the Elicitation of Language Sample Assessment-Toddler version (ELSA-T)
时间窗: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
This 15-minute assessment is developed at the Center for Autism Research Excellence at Boston University. It evaluates expressive language abilities of participants.
Change in predictive gaze measured with eye-tracking
时间窗: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
During the EEG task, eye movements are recorded to assess the child's ability to predict action outcomes.
Change in EEG Frequency Data- Resting State
时间窗: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
EEG frequency data as measured during resting state
Change in EEG Frequency Data- Grasping Objects
时间窗: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
EEG frequency data as measured while subjects grasps an object
Change in parent-child interactions
时间窗: Assessment occurs at week 1, week 6, and week 12, with an intervention in weeks 2-11
A 10-minute play-based parent-child interaction, using a standard set of age-appropriate toys will be recorded and used as part of the child's expressive language sample.
Change in joint attention measured with the Early Social and Communication scales (ESCS)
时间窗: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
This behavioral assessment follows standardized guidelines to capture the full range of joint attention and behavior request skills (initiate and response). A child has a higher score on the ESCS when they demonstrate behavior requests (e.g. pointing to, or asking for, desired objects), or respond to behavior requests (e.g. giving objects to other people) and joint attention (e.g. three-point gaze). In the ESCS, a higher score would indicate higher social and communication abilities.
Change in play level measured with the Structured Play Assessment (SPA)
时间窗: Assessment occurs at week 1 and week 12, with an intervention in weeks 2-11
Developed by Ungerer \& Sigman (1981), this assessment evaluates the child's number and variety of functional and symbolic play acts when introduced sequentially to 5 toy sets.
次要结局
未报告次要终点
研究者
Helen B. Tager-Flusberg
Professor, Psychological & Brain Sciences
Boston University Charles River Campus