Cognitive Control and Metacognition Training

Not Applicable

Not yet recruiting

• Conditions: Autism; Autism Spectrum Disorder

• Registration Number: NCT06885684
• Lead Sponsor: Boston Children's Hospital

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Study Start: 2025-06-30
• Primary Completion: 2027-02-28
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Flanker N2 ERP mean amplitude (primary measure of target engagement)	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.

Secondary Outcome Measures

Name	Time	Method
The Change Task - Stop Signal Reaction Time	Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)	It has four test blocks with Go (75%) and Change trials (25%). Change trials consist of a visual signal to stop the dominant task (i.e., left/right button press) and change response (i.e., space bar). Individual differences in reaction time (RT) are controlled using the mean correct RT from the previous block; stop signals occur equally at 50, 200, 350, and 500ms before each child's RT. Stop signal reaction time (SSRT) is computed via the mean method and estimates the latency to inhibit a dominant response.
Dimensional Change Card Sort t-score	Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)	The National Institute of Health (NIH) Toolbox Dimensional Change Card Sort (DCCS) measures cognitive control set-shifting. Four blocks (practice, pre-switch, post-switch, and mixed) are presented on a tablet. In a pre-switch block of 5 trials, children sort by one dimension (e.g., color). If 80% of trials are correct, they sort by a different dimension (e.g., shape) for 5 post-switch trials. If children pass the post-switch block, they switch back and forth between dimensions for 50 mixed trials (80% 'dominant') presented in a pseudorandom order (with 2-5 dominant trials preceding each non-dominant trial). The dominant dimension is always the sorting dimension used in the post-switch block. Scoring is based on the number of trials administered and integrates both accuracy and RT in a single score.
List Sorting Working Memory Test t-score	Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)	The NIH Toolbox List Sorting Working Memory Test requires children to sort pictures of animals and food. Stimuli appear for 2s while the name of the stimulus is read by a recorded voice. Children must remember each stimulus in a series, mentally reorder them from smallest to largest, and say the names in the new order. The '1-list' section presents only one type of stimulus. In the '2-list' section, children must first sort by category (animal or food) and then size. Scoring combines total items correct across the 1- and 2-list sections.