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

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ClinicalTrials.gov Identifier: NCT03625999
Recruitment Status : Not yet recruiting
First Posted : August 10, 2018
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Carnegie Mellon University
Information provided by (Responsible Party):
Helen B. Tager-Flusberg, Boston University Charles River Campus

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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Autism Behavioral: video game training exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Novel Intervention for Training Auditory Attention in Adolescents With Autism Spectrum Disorder
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Training Group
Parents and children selected for the Training group will be lent an iPad if they do not have one and wish to use one, but they can use a smart phone instead if they prefer. They will be assisted in downloading and installing 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 tablet or smart phone) 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.
Behavioral: 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.
Other Name: game

No Intervention: 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 their own tablet or smart phone), walked through the game's operation and controls, and encouraged to use it as often as they or their child like.



Primary Outcome Measures :
  1. Child Behavioral Assessment: ADOS [ Time Frame: 4-6 weeks ]
    All participants will come back to the center after 4 weeks to complete post-test behavioral assessments, including ADOS (Autism Diagnostic Observation Scale). The ADOS measures autism signs and symptoms. The minimum and maximums range depending on the specific module used (ADOS is available in many modules, the appropriate module to use is selected by the expressive language ability of the participant), but in general, higher scores on the ADOS indicate more severe or widespread symptoms.

  2. Child Behavioral Assessment: Leiter-3 [ Time Frame: 4-6 weeks ]
    All participants will come back to the center after 4 weeks to complete post-test behavioral assessments, including Leiter-3. The Leiter-3 is a nonverbal intelligence assessment, and measures attention, activity level, mood regulation, organizational skills, anxiety, sociability, impulse control, energy & feelings, and sensory reactivity. The range of composite scores is 30-170, and higher numbers indicate higher intelligence scores. The ranges encompass 'severe delay' to 'extremely high/gifted' so it can be used with persons of any ability.

  3. Child Behavioral Assessment: PPVT-4 [ Time Frame: 4-6 weeks ]
    All participants will come back to the center after 4 weeks to complete post-test behavioral assessments, including PPVT-4. The PPVT-4 (Peabody Picture Vocabulary Test) is a booklet containing pictures of commonly known items or objects, used to test receptive vocabulary, for example with verbal prompts such as "Which one is window?", or "Show me phone." The item is scored in terms of % correct responses, with a higher % correct indicating a bigger receptive vocabulary.

  4. Child Behavioral Assessment: EVT-2 [ Time Frame: 4-6 weeks ]
    All participants will come back to the center after 4 weeks to complete post-test behavioral assessments, including EVT-2. EVT-2 is a measure of expressive vocabulary and word retrieval. It can be used to quickly assess expressive vocabulary without requiring reading or writing. Standard scores range from 20 to 160, encompassing 'extremely low' to 'extremely high' so it can be used with persons of any english language ability. Higher scores indicate higher expressive language ability.

  5. Parent Questionnaire: SCQ [ Time Frame: 4-6 weeks ]
    All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the SCQ (Social Communication Questionnaire). The SCQ was designed to evaluate communication skills and social functioning in children who may have ASD, and consists of yes-or-no questions so that it can be completed quickly. Higher scores indicate more severe or widespread symptoms.

  6. Parent Questionnaire: VABS-3 [ Time Frame: 4-6 weeks ]
    All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the VABS-3 (Vineland Adaptive Behavior Scales). The Vineland provides scores for adaptive behavior domains (Communication, Daily Living Skills, Socialization, Motor Skills and Maladaptive Skills), and is designed to assess ability for self-sufficiency based on its ability to measure personal skills needed for everyday life. For each subdomain, scores range from 1 to 24, and for total scores, the range is 20 to 140. In both cases, higher scores indicate a positive ability to use or employ an adaptive behavior in place of a personal weakness or difficulty, so a better ability to work around one's limitations.

  7. Parent Questionnaire: RBS-R [ Time Frame: 4-6 weeks ]
    All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the RBS-R (Repetitive Behavior Scales, revised). The RBS-R provides a quantitative, continuous measure of the full spectrum of repetitive behaviors, consisting of six subscales (Stereotyped behavior, Self-Injurious behavior, Compulsive behavior, Routine behavior, Sameness behavior, and Restricted behavior). Each behavior listed within each subscale is scored on a scale of 0 to 3, where 0 means a behavior does not occur and 3 means a behavior is a severe problem. As such, for the total score, a higher score means more extreme repetitive behaviors.

  8. Parent Questionnaire: SSP [ Time Frame: 4-6 weeks ]
    All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the SSP (Short Sensory Profile). The sensory profile is a measure of responses to sensory events in daily life. There are several sections, encompassing a range of sensory experiences (tactile, taste/smell, movement, seeks sensation, auditory filtering, low energy/weak, and visual/auditory sensitivity), and the total score ranges between 38 and 190, with 38 and other low numbers reflecting an extreme difference from typically developing peers, and 190 and other high numbers reflecting a similarity to typically developing peers.

  9. Parent Questionnaire: CASI-5 [ Time Frame: 4-6 weeks ]
    All participants will come back to the center after 4 weeks to have parents or caregivers complete post-test behavioral questionnaires, including the CASI-5 (Child and Adolescent Symptom Inventory). The CASI-5 is a behavior rating scale that assesses symptoms of a range of 15 different developmental, emotional, and behavioral disorders that can be used to assess any comorbidities a subject may display symptoms for. The scores (total range 0-100) are calculated depending on several factors, but in general, higher numbers indicate the presence of more symptoms (of any disorder) and lower numbers indicate fewer symptoms or less impairment.

  10. Post-test EEG [ Time Frame: 4-6 weeks ]
    All participants will come back to the center after 4 weeks to complete post-test EEG testing. Participants will wear an EEG net connected with elastic threads while listening to sound series designed to assess attention to distinctive sounds. During the task, investigators will assess waveforms alpha, beta, theta, gamma and delta to look for differences in auditory processing between first visit and post-test visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03625999


Contacts
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Contact: Chloe Adams Agarwal 617-358-5910 care@bu.edu

Locations
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United States, Massachusetts
Center for Autism Research Excellence Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Chloe Adams Agarwal    617-358-5910    care@bu.edu   
Principal Investigator: Helen Tager-Flusberg, PhD         
Sponsors and Collaborators
Boston University Charles River Campus
Carnegie Mellon University
Investigators
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Study Chair: Helen Tager-Flusberg, PhD Prinicipal Investigator

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Responsible Party: Helen B. Tager-Flusberg, Principal Investigator, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT03625999     History of Changes
Other Study ID Numbers: 4875E
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helen B. Tager-Flusberg, Boston University Charles River Campus:
Auditory attention

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders