NCT06885684

Cognitive Control and Metacognition Training

Developing Cognitive Control and Metacognition to Reduce the Functional Impact of Restricted and Repetitive Behaviors in Autism

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Autism
• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Control Training + Metacognition Coaching	Computer training is delivered in person by a coach. Training consists of four games; each requires multiple aspects of cognitive control. Training levels progress in difficulty by increasing the number of items or simultaneous dimensions, decreasing the available response time, requiring greater accuracy, or adjusting the proportion of distractors or their complexity. Parameters that influence the difficulty of each level and passing criteria are fixed, but children progress from level to level at their own pace. Training is accompanied by manualized metacognition coaching to provide strategies to meaningfully engage with the tasks, simplify the tasks, support sustained effort, emphasize key cognitive control skills needed, provide coping strategies to reduce frustration associated with challenging aspects of the games, and use guided conversations to highlight metacognition.

Timeline

• Start date: 2025-06-30
• Primary completion: 2027-02-28
• Completion: 2027-06-30
• First posted: 2025-03-20
• Last updated: 2025-03-20