Clinical trial NCT03625999: A Novel Intervention for Training Auditory Attention in Adolescents With Autism Spectrum Disorder
Official title: A Novel Intervention for Training Auditory Attention in Adolescents With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Keywords: Auditory attention
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Carnegie Mellon University
First posted: 2018-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Child Behavioral Assessment: ADOS
timeFrame: 4-6 weeks
measure: Child Behavioral Assessment: Leiter-3
timeFrame: 4-6 weeks
measure: Child Behavioral Assessment: PPVT-5
timeFrame: 4-6 weeks
measure: Child Behavioral Assessment: EVT-3
timeFrame: 4-6 weeks
measure: Parent Questionnaire: SCQ
timeFrame: 4-6 weeks
measure: Parent Questionnaire: VABS-3
timeFrame: 4-6 weeks
measure: Parent Questionnaire: RBS-R
timeFrame: 4-6 weeks
measure: Parent Questionnaire: SSP
timeFrame: 4-6 weeks
measure: Parent Questionnaire: CASI-5
timeFrame: 4-6 weeks
measure: Post-test EEG
timeFrame: 4-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Autism Research Excellence
state: Massachusetts
Study officials:
affiliation: Prinicipal Investigator
name: Helen Tager-Flusberg, PhD
role: STUDY_CHAIR
References: