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Gaming for Autism to Mold Executive Skills Project (GAMES)

Boston Children's Hospital logo

Boston Children's Hospital

Status

Completed

Conditions

Autism Spectrum Disorders

Treatments

Behavioral: Computerized executive control training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02361762
P00014188
R00HD071966 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

7 to 11 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Training
Experimental group
Description:
Computerized executive control training
Treatment:
Behavioral: Computerized executive control training
Waitlist
No Intervention group
Description:
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.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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