N/A
N=70
Gaming for Autism to Mold Executive Skills Project
Autism Spectrum Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02361762 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Change Task - Stop Signal Reaction Time — 233.8; 238.3; 213.6; 234.7 miliseconds — p=0.36
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Computerized executive control training (Behavioral)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change Task - Stop Signal Reaction Time |
233.8; 238.3; 213.6; 234.7 | 0.36 |
| PRIMARY Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials) |
3.8; 6.0; 2.9; 3.8 | 0.79 |
| PRIMARY Event-related Potentials Assessed During Child Attention Network Flanker Task |
-.20; -2.5; .83; -3.8; -1.0; -3.7 | 0.009 sig |
| PRIMARY BRIEF Parent Survey (Global Executive Composite) |
66.55; 68.40; 65.85; 67.77 | .79 |
| SECONDARY Backward Digit Span (Scaled Score) |
10.42; 9.83; 10.15; 9.55 | 0.61 |
| SECONDARY Social Attribution Task (SAT) - Problem Solving Scale |
34.6; 33.8; 32.9; 31.0 | 0.68 |
| SECONDARY Theory of Mind Composite: Perception Knowledge, Location Change False Belief, Unexpected-contents False Belief |
75; 71; 90; 84 | 0.54 |
| SECONDARY TOM Test (Theory of Mind Test) |
66; 63; 71; 65 | 0.08 |
| SECONDARY Social Skills Improvement System-Parent (SSIS) - Social Standard Score |
81.63; 80.47; 81.69; 79.33 | 0.37 |
| SECONDARY Narrative Language Task |
— | — |
| SECONDARY Performance on Hungry Donkey Task Assessed as Ratio of Safe to Risky Selections |
1.39; 0.16; 0.33; 1.74 | 0.62 |
| SECONDARY Event-related Potentials Assessed During Cued Go/Nogo Task |
-2.4; -2.9; -1.6; -3.0; -1.1; -2.3 | 0.10 |
Summary
The goal of the project is to better understand executive control-how children manage complex or conflicting information in the service of a goal. This skill has been linked to social and academic functioning in typically developing children. Executive control is often reduced in children with autism spectrum disorder (ASD), but it has not been a focus of treatment. This project will have the goal of determining whether computer-training tasks developed to enhance the executive control skills of preschoolers and school-aged children without autism are appropriate for children with ASD. The investigators do not yet know if this training is beneficial for children with ASD. In addition, because executive control has been found to relate to social knowledge and problem solving, the investigators will collect information with this type of task to measure possible effects of training.
Eligibility Criteria
Inclusion Criteria
- Children should be 7 to 11 years of age
- Children must have a parent/guardian who is available and willing to provide informed consent and to respond to screening phone calls
- 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
Exclusion Criteria
- Children must not have a seizure disorder or be taking medication that alters EEG processes (e.g. anti-seizure medications)
- Children must not have medical disorders or injuries affecting the brain or spinal cord
- Children may not have experienced significant prenatal exposure to substances such as tobacco, alcohol or street drugs
- Children may not have significant sensory or motor impairment that would limit the ability to participate in table top or EEG testing, or make responding during computer activities difficult
Data sourced from ClinicalTrials.gov (NCT02361762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.