Cognitive Control and Metacognition Training

NCT ID: NCT06885684

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Control Training + Metacognition Coaching

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Faja, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital / Harvard Medical School

Central Contacts

Susan Faja, PhD

Role: CONTACT

susan.faja@childrens.harvard.edu

6179194486

Doo-yun Her

Role: CONTACT

617-919-4108

Other Identifiers

FP01034542

Identifier Type: -

Identifier Source: org_study_id