Condition category
Mental and Behavioural Disorders
Date applied
18/05/2015
Date assigned
27/05/2015
Last edited
27/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

‚ÄčProfessor 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 measures

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

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

Sponsor information

Organisation

National Plan for Science and Technology (NPST)/King Abdulaziz City for Science and Technology (KACST)

Sponsor details

King Saud University
P.O Box 6086
Riyadh
11442
Saudi Arabia

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes