Gaming for Autism to Mold Executive Skills Project

NCT ID: NCT02361762

Last Updated: 2021-07-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Training

Computerized executive control training

Group Type EXPERIMENTAL

Computerized executive control training

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Susan Faja

Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Faja, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital: Labs of Cognitive Neuroscience- Faja Lab

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35481725 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R00HD071966

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P00014188

Identifier Type: -

Identifier Source: org_study_id

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