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11 February 2012
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| [ Print-friendly version ] |
| Study of the effectiveness of Auditory integration therapy in the treatment of auditory hypersensitivity in autism spectrum disorders |
| ISRCTN | ISRCTN32927930 |
| ClinicalTrials.gov identifier | |
| Public title | Study of the effectiveness of Auditory integration therapy in the treatment of auditory hypersensitivity in autism spectrum disorders |
| 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 |
| Serial number at source | N/A |
| Study hypothesis | Auditory integration therapy is effective in reducing the auditory hypersensitivity in autistic children |
| Lay summary | |
| 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 |
| Countries of recruitment | Saudi Arabia |
| Disease/condition/study domain | Autism spectrum disorders |
| Participants - inclusion criteria | Autism spectrum disorders with auditory sensory hypersensitivity |
| Participants - exclusion criteria |
1. Epilepsy
2. Cerebral palsy 3. Tuberous sclerosis |
| Anticipated start date | 01/01/2010 |
| Anticipated end date | 01/01/2012 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet (in Arabic) |
| Target number of participants | 100 |
| Interventions |
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). |
| Primary outcome measure(s) | Reflection in sensory hypersensitivity, assessed at baseline. 3, 6 and 9 months. |
| Secondary outcome measure(s) |
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 |
| Sources of funding | King Abdul Aziz City for Science and Technology (KACST) (Saudi Arabia) |
| Trial website | |
| Publications | |
| Contact name | Prof Laila AL-Ayadhi |
| Address |
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 |
| City/town | Riyadh |
| Zip/Postcode | 11461 |
| Country | Saudi Arabia |
| Sponsor | King Abdul Aziz City for Science and Technology (KACST) (Saudi Arabia) |
| Address |
Riyadh
PO Box 6068 |
| City/town | Riyadh |
| Zip/Postcode | 11442 |
| Country | Saudi Arabia |
| Tel | +966 (0)14883555 |
| Fax | +966 (0)14813274 |
| npst7@ksu.edu.sa | |
| Sponsor website: | http://www.kacst.edu.sa |
| Date applied | 24/12/2009 |
| Last edited | 31/08/2010 |
| Date ISRCTN assigned | 31/08/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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