Clinical trial NCT06885684: Cognitive Control and Metacognition Training
Official title: Developing Cognitive Control and Metacognition to Reduce the Functional Impact of Restricted and Repetitive Behaviors in Autism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 95
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Flanker N2 ERP mean amplitude (primary measure of target engagement)
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)
Secondary outcomes:
measure: The Change Task - Stop Signal Reaction Time
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)
measure: Dimensional Change Card Sort t-score
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)
measure: List Sorting Working Memory Test t-score
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)
Other outcomes:
Locations:
Study officials:
affiliation: Boston Children's Hospital / Harvard Medical School
name: Susan Faja, PhD
role: PRINCIPAL_INVESTIGATOR
References: