Condition category
Mental and Behavioural Disorders
Date applied
24/12/2009
Date assigned
31/08/2010
Last edited
31/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Laila AL-Ayadhi

ORCID ID

Contact details

Auditory Integration Therapy Project (AIT)
Professor of Neurophysiology
Consultant Diagnostic Neurophysiology
Autism Research and Treatment Centre (ART Centre) (99)
Department of physiology (29)
Faculty of Medicine
King Saud University
P O Box 2925
Riyadh
11461
Saudi Arabia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effectiveness of Auditory integration therapy in the treatment of auditory hypersensitivity in autism spectrum disorders: A single blind randomised controlled trial study

Acronym

AIT Autism

Study hypothesis

Auditory integration therapy is effective in reducing the auditory hypersensitivity in autistic children

Ethics approval

The College of Medicine and King Khalid University Ethics Committee approved on the 27th of December 2009. (ref: E-09-065)

Study design

Single centre randomised controlled interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (in Arabic)

Condition

Autism spectrum disorders

Intervention

The children will be assessed as follows:
1. Physician (to confirm the diagnosis) using
1.1. The Developmental, Dimensional and Diagnostic interview (3DI)
1.2. Childhood Autism Rating Scale (CARS)
2. Parents and Psychologist will fill the following
2.1. Health questionnaire
2.2. ORCA Diagnostic check list
2.3. Autism Treatment Evaluation Checklist (ATEC)
3. ENT specialist
Children with a history of seizure disorder will be excluded.
Written informed consent will be obtained from the parents/guardian.
During the study period, children were not allowed to begin any new therapies or stop any current therapies, including medications and supplements.

Auditory integration training will be conducted according to the following protocol:
The listener receives 18 to 20 listening sessions lasting for 30 minutes, over a 10- to 20-day period. In most cases, with a 1- or 2-day break after 5 days of listening. During the listening sessions, the child listens to processed music. That is, the AIT sound amplifier attenuates low and high frequencies at random from the compact discs, and then sends this modified music through headphones to the listener. This random selection of frequencies is termed 'modulation.' The intensity level (volume) during the AIT listening sessions should not exceed 85 decibels (dBA).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Reflection in sensory hypersensitivity, assessed at baseline. 3, 6 and 9 months.

Secondary outcome measures

1. Increased attention
2. Better hearing
3. Increased concentration
Outcomes assessed at baseline, 3, 6 and 9 months, using the following tools:
1. Parent Questionnaire
2. Health Q!uestionnaire
3. ORCA diagnositic checklist
4. CARS
5. ATEC

Overall trial start date

01/01/2010

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Autism spectrum disorders with auditory sensory hypersensitivity

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Epilepsy
2. Cerebral palsy
3. Tuberous sclerosis

Recruitment start date

01/01/2010

Recruitment end date

01/01/2012

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

Auditory Integration Therapy Project (AIT)
Riyadh
11461
Saudi Arabia

Sponsor information

Organisation

King Abdul Aziz City for Science and Technology (KACST) (Saudi Arabia)

Sponsor details

Riyadh
PO Box 6068
Riyadh
11442
Saudi Arabia
+966 (0)14883555
npst7@ksu.edu.sa

Sponsor type

Research organisation

Website

http://www.kacst.edu.sa

Funders

Funder type

Research organisation

Funder name

King Abdul Aziz 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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes