Cognitive Control and Metacognition Training

Sponsor
Boston Children's Hospital
Study ID
NCT06885684
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 11 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Mar 20, 2025
Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Feb 28, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
95 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

Flanker N2 ERP mean amplitude (primary measure of target engagement) [ Time Frame: Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase) ]

Central Contacts

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