Cognitive Control and Metacognition Training
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-11
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Control Training + Metacognition Coaching
BehavioralComputer 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.
Treatment groups
95 Participants
are divided into 2 treatment groupsGroup A: Cognitive Control Training + Metacognition CoachingExperimental treatment 1 intervention
Group B: WaitlistNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)Secondary outcomes
1
The Change Task - Stop Signal Reaction Time
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.
Time frame
Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)2
Dimensional Change Card Sort t-score
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.
Time frame
Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)3
List Sorting Working Memory Test t-score
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.
Time frame
Baseline (Pre Training/Waitlist Phase) and at 15-17 Weeks (Post Training/Waitlist Phase)Locations
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Source ClinicalTrials.gov
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