Study of the effectiveness of Auditory integration therapy in the treatment of auditory hypersensitivity in autism spectrum disorders

ISRCTN	ISRCTN32927930
DOI	https://doi.org/10.1186/ISRCTN32927930
Secondary identifying numbers	N/A

Submission date: 24/12/2009
Registration date: 31/08/2010
Last edited: 31/08/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Laila AL-Ayadhi
Scientific

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

Study information

Study design	Single centre randomised controlled interventional study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet (in Arabic)
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
Study acronym	AIT Autism
Study objectives	Auditory integration therapy is effective in reducing the auditory hypersensitivity in autistic children
Ethics approval(s)	The College of Medicine and King Khalid University Ethics Committee approved on the 27th of December 2009. (ref: E-09-065)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2010
Completion date	01/01/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	100
Key inclusion criteria	Autism spectrum disorders with auditory sensory hypersensitivity
Key exclusion criteria	1. Epilepsy 2. Cerebral palsy 3. Tuberous sclerosis
Date of first enrolment	01/01/2010
Date of final enrolment	01/01/2012

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

Auditory Integration Therapy Project (AIT)

Riyadh
11461
Saudi Arabia

Sponsor information

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

Riyadh
PO Box 6068
Riyadh
11442
Saudi Arabia

Phone	+966 (0)14883555
Email	npst7@ksu.edu.sa
Website	http://www.kacst.edu.sa
"ROR"	https://ror.org/05tdz6m39

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan