Clinical trial NCT02361762: Gaming for Autism to Mold Executive Skills Project
Official title: Electrophysiological Response to Executive Control Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: Executive Function
Theory of Mind
Individual Differences
Social Skills
Executive Control
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-02-12
Enrollment: 70
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Participation will include two phone calls to determine if the study is a good fit and collect some preliminary information, five visits to Boston Children's Hospital (3 before training and 2 about 6-8 weeks later), caregiver questionnaires, and an optional teacher questionnaire packet. The visits will include activities designed to assess verbal and nonverbal thinking ability; social skills and general interests; and specific tasks related to cognitive and social problem solving. In addition, EEG measurement of brain function will be made. EEG is a non-invasive recording of brain activity. Children will be randomly assigned (i.e., like flipping a coin) to receive training or to a non-training group. The training group will complete tasks designed to improve executive control presented over the course of 5-10 1-hour sessions. All tasks are game-like and are presented on a computer with child friendly graphics. A staff member will work with each child as he/she completes the training activities. Children assigned to the non-training group will be invited to participate in training at the end of the study if it is shown to improve executive control.

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

Primary outcomes:
measure: Change Task - Stop Signal Reaction Time
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
measure: Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials)
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
measure: Event-related Potentials Assessed During Child Attention Network Flanker Task
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
measure: BRIEF Parent Survey (Global Executive Composite)
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Secondary outcomes:
measure: Backward Digit Span (Scaled Score)
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
measure: Social Attribution Task (SAT) - Problem Solving Scale
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
measure: Theory of Mind Composite: Perception Knowledge, Location Change False Belief, Unexpected-contents False Belief
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
measure: TOM Test (Theory of Mind Test)
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
measure: Social Skills Improvement System-Parent (SSIS) - Social Standard Score
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
measure: Narrative Language Task
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
measure: Performance on Hungry Donkey Task Assessed as Ratio of Safe to Risky Selections
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
measure: Event-related Potentials Assessed During Cued Go/Nogo Task
timeFrame: Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital: Labs of Cognitive Neuroscience- Faja Lab
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Susan Faja, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edmunds SR, MacNaughton GA, Rueda MR, Combita LM, Faja S. Beyond group differences: Exploring the preliminary signals of target engagement of an executive function training for autistic children. Autism Res. 2022 Jul;15(7):1261-1273. doi: 10.1002/aur.2735. Epub 2022 Apr 28.