Developing Cognitive Control and Metacognition to Reduce the Functional Impact of Restricted and Repetitive Behaviors in Autism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 95
- 主要终点
- Flanker N2 ERP mean amplitude (primary measure of target engagement)
研究概览
简要总结
95 autistic children (ages 8-11yrs) will be randomly assigned to a novel computer-based Cognitive Control Training combined with Metacognition Coaching or to a comparison group that receives the intervention after a delay. Before and after intervention, electroencephalography (EEG) will be used to examine engagement of the target neural responses.
详细描述
Effective interventions to reduce the functional impact of core features of autism spectrum disorder (ASD) in school-aged children are critically needed. This study will test whether in-person computer training delivered individually by a coach engages an electroencephalographic (EEG) biomarker of cognitive control (N2 event-related potential [ERP] amplitude). Developing more effective cognitive control, metacognition, and working memory is predicted to enhance neural responses to conflicting information (i.e., a neural marker of effective cognitive control). The study will randomly assign 95 autistic children (ages 8-11yrs) to a novel computer-based Cognitive Control Training combined with Metacognition Coaching or to a waitlist control group. Before and after intervention, EEG will be used to examine engagement of the target neural responses. We expect the group assigned to Cognitive Control Training + Metacognition Coaching to exhibit significantly larger changes in N2 ERP amplitude in incongruent relative to congruent trials than the waitlist group. Before and after intervention, we will collect neural responses and behavioral measures of cognitive control and working memory.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
biostatistician; eeg analyst
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children should be 8 to 11 years of age
- •Children should have an existing diagnosis of an autism spectrum disorder, which will be confirmed using research measures and criteria
- •Children must have general cognitive ability in the average range or above (above 80 using the Wechsler Abbreviated Scale of Intelligence-2 Full Scale IQ)
- •Caregivers and children must be fluent in English or Spanish
排除标准
- •Children must not have a known genetic condition related to autism (e.g., Fragile X)
- •Children must not have medical conditions/injuries, exposure to substances, or significant deprivation with implications for the central nervous system or that require regular psychoactive medications that alter EEG responses (anticonvulsants, barbiturates) *
- •Children must not have seizures or a seizure disorder (other than history of febrile seizures)
- •Children must not have significant sensory or motor impairment or major physical abnormalities that would limit the ability to participate in table top or EEG testing, or make responding during computer activities difficult
- •Children must not have a failed screening for colorblindness
研究组 & 干预措施
Cognitive Control Training + Metacognition Coaching
Intervention will be delivered individually in person. Cognitive Control (CC) Computer Training consists of four games that require multiple aspects of CC (flexible thinking, inhibitory control) and working memory. Each game has approximately 20 levels of increasing difficulty. Parameters that contribute to the difficulty and passing criteria are fixed, but children progress from level to level at their own pace. Metacognition Coaching employs manualized strategies that: meaningfully engage children with the training tasks; simplify tasks to make them more manageable; support sustained effort; emphasize key CC skills needed for tasks; provide coping strategies to reduce frustration associated with challenging aspects of the games; and use guided conversations to aid children with mastering each game. To support the needs of children with ASD, key concepts are described using consistent language and visual supports throughout training sessions.
干预措施: Cognitive Control Training + Metacognition Coaching (Behavioral)
Waitlist
The waitlist group will continue with any ongoing interventions (treatment as usual) and will not initially receive the training program. At the end of the study, the waitlist group will be offered training.
结局指标
主要结局
Flanker N2 ERP mean amplitude (primary measure of target engagement)
时间窗: Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)
The flanker portion of the Child Attention Network Task (ANT) measures neural response to CC monitoring and inhibition. It includes 12 practice and 108 test trials. Each trial begins with a 150ms beep paired with a 450ms fixation cross at the center of the screen. Then, a target and flankers are presented for 2000ms. Congruent trials (50%) include a central target animal flanked by two animals on each side with the same orientation and size as the target. Incongruent trials (50%) are identical except that the target and flankers face opposite directions. Children use two buttons to show the direction each target is facing (50% left, 50% right) and receive feedback.
次要结局
- The Change Task - Stop Signal Reaction Time(Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase))
- Dimensional Change Card Sort t-score(Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase))
- List Sorting Working Memory Test t-score(Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase))
研究者
Susan Faja
Associate Professor, Scientist
Boston Children's Hospital