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Gaming for Autism to Mold Executive Skills Project (GAMES)

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ClinicalTrials.gov Identifier: NCT02361762
Recruitment Status : Completed
First Posted : February 12, 2015
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Susan Faja, Boston Children’s Hospital

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 disorders, 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Behavioral: Computerized executive control training Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electrophysiological Response to Executive Control Training
Study Start Date : February 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Training
Computerized executive control training
Behavioral: Computerized executive control training

Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.

Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.

A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks.


No Intervention: Waitlist
The waitlist group will not initially receive the training program. At the end of the study, the waitlist group will be offered training if it is efficacious.



Primary Outcome Measures :
  1. Change Task [ Time Frame: Baseline & Post-Training/Wait-listed phase (approximately 6-8 weeks from randomization) ]
    Conflict Processing-Behavior (change scores: Post-testing minus Baseline)

  2. Stroop Task [ Time Frame: Baseline & Post-Training/Wait-listed phase (approximately 6-8 weeks from randomization) ]
    Conflict Processing-Behavior (change scores: Post-testing minus Baseline)

  3. Child Attention Network Task (Child ANT) [ Time Frame: Baseline & Post-Training/Wait-listed phase (approximately 6-8 weeks from randomization) ]
    Conflict Processing-ERP Brain Response (change scores: Post-testing minus Baseline)

  4. BRIEF Parent and Teacher Surveys [ Time Frame: Baseline & Post-Training/Wait-listed phase (approximately 6-8 weeks from randomization) ]
    Executive Control at home/school-Generalization (change scores: Post-testing minus Baseline)


Secondary Outcome Measures :
  1. Backward Digit Span [ Time Frame: Baseline & Post-Training/Wait-listed phase (approximately 6-8 weeks from randomization) ]
    Working Memory Behavior (change scores: Post-testing minus Baseline)

  2. Social Attribution Task (SAT) [ Time Frame: Baseline & Post-Training/Wait-listed phase (approximately 6-8 weeks from randomization) ]
    Theory of Mind Behavior (change scores: Post-testing minus Baseline)

  3. TOM Composite: Perception Knowledge, Location Change False Belief, Unexpected-contents False Belief [ Time Frame: Baseline & Post-Training/Wait-listed phase (approximately 6-8 weeks from randomization) ]
    Theory of Mind Behavior (change scores: Post-testing minus Baseline)

  4. TOM Test [ Time Frame: Baseline & Post-Training/Wait-listed phase (approximately 6-8 weeks from randomization) ]
    Theory of Mind Behavior (change scores: Post-testing minus Baseline)

  5. Social Skills Improvement System-Parent / Teacher (SSIS) [ Time Frame: Baseline & Post-Training/Wait-listed phase (approximately 6-8 weeks from randomization) ]
    Social function home/school (change scores: Post-testing minus Baseline)

  6. Narrative Language Task [ Time Frame: Baseline & Post-Training/Wait-listed phase (approximately 6-8 weeks from randomization) ]
    Social Communication Ability Behavior (change scores: Post-testing minus Baseline)

  7. Hungry Donkey Task [ Time Frame: Baseline & Post-Training/Wait-listed phase (approximately 6-8 weeks from randomization) ]
    Conflict Processing (Reward) Behavior (change scores: Post-testing minus Baseline)

  8. Cued Go/Nogo [ Time Frame: Baseline & Post-Training/Wait-listed phase (approximately 6-8 weeks from randomization) ]
    Conflict Processing-ERP Brain Response (change scores: Post-testing minus Baseline)



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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361762


Locations
United States, Massachusetts
Boston Children's Hospital: Labs of Cognitive Neuroscience- Faja Lab
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Susan Faja, Ph.D. Boston Children’s Hospital

Additional Information:
Responsible Party: Susan Faja, Research Associate, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02361762     History of Changes
Other Study ID Numbers: P00014188
R00HD071966 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

Keywords provided by Susan Faja, Boston Children’s Hospital:
Executive Function
Theory of Mind
Individual Differences
Social Skills
Executive Control

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders