Cognitive Control and Metacognition Training

NCT06885684 | Not Yet Recruiting

• 1 other identifier: FP01034542
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Flanker N2 ERP mean amplitude (primary measure of target engagement)

  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.

  Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Cognitive Control Training + Metacognition Coaching

EXPERIMENTAL

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.

Behavioral: Cognitive Control Training + Metacognition Coaching

Waitlist

NO INTERVENTION

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.

Interventions

Cognitive Control Training + Metacognition Coaching 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.

Cognitive Control Training + Metacognition Coaching

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Susan Faja, PhD

  Boston Children's Hospital / Harvard Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Faja, PhD

CONTACT

6179194486; susan.faja@childrens.harvard.edu

Doo-yun Her

CONTACT

617-919-4108

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: biostatistician; eeg analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Scientist

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 20, 2025
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04