A Novel Intervention for Training Auditory Attention in Adolescents With Autism Spectrum Disorder

NCT ID: NCT03625999

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2021-09-30

Brief Summary

Background: Previous research has shown that individuals with ASD often have difficulties coping with auditory stimuli in the environment. These difficulties can be extremely debilitating, lead to anxiety and disruptive behaviors, and interfere with the ability to process and understand speech.

Research Design: In previous research, the investigators have identified a brain marker associated with poor auditory attention that can provide a direct readout of auditory processing issues. The investigators will develop and test a cognitive/behavioral intervention (a tablet-based game app) that is highly engaging and accessible to a wide range of individuals with ASD. The intervention is designed to train adolescents with ASD to adapt and attend to auditory cues.

Objectives: To evaluate whether the intervention leads to improvement in auditory attention as assessed by behavior changes over the course of training; to investigate the impact of the intervention on behavioral assessment of problems hearing speech in noisy environments, neural processing of sounds, and changes in parent report on responses to sounds that impact that daily lives of the participants; and finally- to determine which adolescents with ASD benefit the most and least from interventions such as this one.

We hypothesize that we can elicit changes in the neural processing of sounds for adolescents with ASD via training in the form of the tablet-based game we are developing. If we are successful, this could lead to other interventions for persons with ASD in the hopes of improving the auditory difficulties they face.

Conditions

Autism Spectrum Disorder; Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Training Group

Parents and children selected for the Training group will be lent a laptop for the duration of the at-home training, and assisted in opening the video game training exercise. Parents and children will be shown the game's operation and controls, including a home visit to the family's house to help them establish the game as part of routine. Parents will be asked to engage their children in the video game training exercise (on the laptop) for a minimum of 20 minutes, 3 times a week, for 4 weeks. The app will log all responses as well as time spent playing.

Group Type: EXPERIMENTAL

video game training exercise

Intervention Type: BEHAVIORAL

The game, called "The Silent Service" and developed by our collaborators, is an online game with an underwater theme, and is comprised of 5 distinct mini-games, each of which demands auditory attention. The mission is to navigate an underwater scene, listening and responding to 'sonar' (e.g., an oddball in a stream of sounds). For example, participants may have to respond to an oddball sound stream to protect their submarine from a looming sea monster, while successfully ignoring a distractor sound stream (responses to the distractor sound stream allow the sea monster to damage the submarine). The five games share the same underlying framework of detecting oddballs while ignoring distractors but have unique artwork and 'backstories' to keep players interested. There is a hierarchical reward structure for 'leveling up' across the game that helps players to stay engaged and interested while playing.

Wait-List Control

The families assigned to the wait-list control group will not receive access to the game until after 4 weeks and completion of the secondary round of testing at the lab. After the second lab visit and completion of the testing, families will be given access to the video game training exercise (on a loaned laptop), walked through the game's operation and controls, and encouraged to use it as often as they or their child like. If the child plays the game for a minimum of 20 minutes, 3 times per week, for 4 weeks, the family will be invited back to CARE for post-testing.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

video game training exercise

The game, called "The Silent Service" and developed by our collaborators, is an online game with an underwater theme, and is comprised of 5 distinct mini-games, each of which demands auditory attention. The mission is to navigate an underwater scene, listening and responding to 'sonar' (e.g., an oddball in a stream of sounds). For example, participants may have to respond to an oddball sound stream to protect their submarine from a looming sea monster, while successfully ignoring a distractor sound stream (responses to the distractor sound stream allow the sea monster to damage the submarine). The five games share the same underlying framework of detecting oddballs while ignoring distractors but have unique artwork and 'backstories' to keep players interested. There is a hierarchical reward structure for 'leveling up' across the game that helps players to stay engaged and interested while playing.

Intervention Type: BEHAVIORAL

Other Intervention Names

game

Eligibility Criteria

Inclusion Criteria

• Adolescent children and young adults, both males and females;
• Between the ages of 13:0 and 20:11 years of age
• Speak or hear English at home at least 50% of the time
• Meet criteria for a confirmed diagnosis of Autism Spectrum Disorder.

Exclusion Criteria

• Nonverbal mental age below 18 months
• Insufficient manual dexterity that would prevent working with a tablet or phone-based app

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carnegie Mellon University

OTHER

Sponsor Role: collaborator

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Helen B. Tager-Flusberg

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen Tager-Flusberg, PhD

Role: STUDY_CHAIR

Prinicipal Investigator

Locations

Center for Autism Research Excellence

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

4875E

Identifier Type: -

Identifier Source: org_study_id