Plain English Summary
Background and study aims
Autism spectrum disorder (ASD) is a condition that usually starts to develop in childhood. ASD is characterised by symptoms such as problems with social interaction and communication, and restricted and repetitive interests or physical behaviours. There is no cure for ASD, but there are various educational and behavioural treatment programmes available that can benefit people with the condition. Once such treatment is auditory integration training (AIT), which is a form of sound therapy developed by Dr Guy Berard in 1963. AIT sessions are carried out in treatment centres across a 10-20 day period, and individuals listen to programme-designed music through modified headphones for 30 minutes, twice a day. AIT has been shown to help patients with ASD, attention deficit hyperactivity disorder (ADHD), learning disabilities, common developmental disorders, sound sensitivity and speech comprehension problems, among others. The aim of this study is to assess the effects of AIT on specific areas of brain (neurocognitive) function in children with ASD.
Who can participate?
Children diagnosed with ASD.
What does the study involve?
All participants are given AIT treatment according to the Berard method. This involves 10, twice-daily, 30 minute clinic-based AIT sessions, separated by at least 3 hours. Some participants may require an additional 10-day treatment under the same conditions. Before starting AIT, participants are trained to wear the headphones at the clinic by a Berard practitioner; parents are also given training to help their child with the headphones. Participants are asked to take part in various questionnaires and computer-based tests which are used to assess specific areas of brain function, such as memory, attention and decision making (neuropsychological tests). These tests are carried out before treatment starts, and are then repeated 1 day, 1 month and 3 months after treatment.
What are the possible benefits and risks of participating?
Possible benefits of participating in this study include improved speech, communication, social communication and social awareness. There are no risks anticipated.
Where is the study run from?
Autism Research and Treatment Center (ART), Al-Amoudi Chair for Autism (Saudi Arabia)
When is the study starting and how long is it expected to run for?
July 2015 to July 2017
Who is funding the study?
National Plan for Science and Technology (NPST)/King Abdulaziz City for Science and Technology (KACST) (Saudi Arabia)
Who is the main contact?
Prof L AL-Ayadhi
Trial website
Contact information
Type
Scientific
Primary contact
Professor Laila AL-Ayadhi
ORCID ID
http://orcid.org/0000-0003-3269-0416
Contact details
Professor and Consultant of Neurophysiology
Director of KSU-Autism Research and Treatment center (99)
Supervisor of Sheikh AL-Amoudi Autism Research Chair
King Saud University
Department of physiology (29)
Faculty of Medicine
P O Box 2925
Riyadh 11461
Saudi Arabia
Riyadh
11461
Saudi Arabia
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04
Study information
Scientific title
The effect of auditory integration therapy on neurocognitive function in autism
Acronym
Study hypothesis
Auditory integration therapy (AIT) can improve cognitive function in patients with autism.
Ethics approval
Ethics Committee of King Saud University College of Medicine and King Khalid University Hospital, 04/05/2015, ref: E-t5-t454.
Study design
Observational interventional single center study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Home
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Autism
Intervention
AIT, introduced by Berard Method: listening to 10 hours of modified music through headphones in 20 half-hours sessions twice daily with at least 3 hour interval between over a 10-20 day period.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Measured before intervention, then again one day, one month and 3 months following AIT:
1. Cambridge neuropsychological test automated battery (CANTAB)
2. Childhood autism rating scale (CARS)
3. Social responsiveness scale (SRS)
4. Sensory profile (SP)
5. IQ
Secondary outcome measures
1. Speech
2. Communication
3. Social interaction
4. Academic performance
Overall trial start date
01/07/2015
Overall trial end date
01/07/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children diagnosed with autism
2. Normal peripheral hearing and middle ear function assessed by audiological evaluation performed by an ear, nose and throat specialist (ENT)
3. Parental/child consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. History of seizure disorder
2. Abnormal peripheral hearing
3. Abnormal middle ear function
4. Associated neurological diseases (such as cerebral palsy and tuberous sclerosis)
5. Metabolic disorders (e.g. phenylketonuria)
Recruitment start date
01/09/2015
Recruitment end date
01/07/2016
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
Autism Research and Treatment Center (ART), Al-Amoudi Chair for Autism
P O Box 2959
Riyadh
11461
Saudi Arabia
Funders
Funder type
University/education
Funder name
National Plan for Science and Technology (NPST)/King Abdulaziz City for Science and Technology (KACST) (Saudi Arabia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The aim is to publish the results in international peer review scientific journals, and any related conferences.
Intention to publish date
01/01/2018
Participant level data
Available on request
Basic results (scientific)
Publication list