checking the effect of tele rehabilitation on the pattern of sensory processing, social competence and occupational performance of autism children
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, control group: 16 autistic children, intervention group: 16 autistic children
Settings and conduct
In the first phase, the sensory diet intervention protocol is written for 4 sensory processing patterns. In the second phase, the samples are divided into two groups: in-person and tele occupational therapy. The intervetions of both group are done during 8 weeks. (12 sessions/ each session: 30 minutes)
the sessions of tele occupational therapy are in the form of video/audio conference. A special sensory diet is given to each child during the sessions.
Participants/Inclusion and exclusion criteria
(1) diagnosis of autism spectrum disorder by a child psychiatrist and diagnosis of level one and two of autism spectrum disorder by an occupational therapist (Gilliam Autism Rating Scale, third edition) (2) age range: 4-10 years, (3) not having neurological disorders such as epilepsy and other psychiatric disorders
Intervention groups
Intervention group: receiving a sensory diet through tele occupational therapy/Control group: receiving a sensory diet through face-to-face occupational therapy
Main outcome variables
Tele occupational therapy, sensory processing, social competency, occupational performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221128056651N1
Registration date:2022-12-16, 1401/09/25
Registration timing:registered_while_recruiting
Last update:2022-12-16, 1401/09/25
Update count:0
Registration date
2022-12-16, 1401/09/25
Registrant information
Name
Simin Dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 9884
Email address
siminotdehghani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tele rehabilitation on the pattern of sensory processing, social competence and occupational performance of autism children
Public title
The effect of tele rehabilitation on the pattern of sensory processing, social competence and occupational performance of autism children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
(1) diagnosis of autism spectrum disorder by a child psychiatrist and diagnosis of level one and two of autism spectrum disorder by an occupational therapist (Gilliam Autism Rating Scale, third edition) (2) age range: 4-10 years, (3) not having neurological disorders such as epilepsy and other psychiatric disorders
Exclusion criteria:
Age
From 4 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Children with autism spectrum disorder (level 1 and 2) will be selected by available sampling from the autism rehabilitation centers in Tehran. Children who have the entry criteria will be selected. Then, a demographic information questionnaire will be completed and a written consent form will be received from all people who have the entry criteria. the occupational therapist provides an pocket for the caregivers to choose a card from. The arrangement of the cards will be random and card A represents the intervention group and card B represents the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The initial and final tests will be done by another occupational therapist who is proficient in the tests.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pajoohan. Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Yaman Street, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-12-13, 1401/09/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.570
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sensory processing pattern, social competency and occupational performance
Timepoint
Before and after the intervention and one month after the intervention
Method of measurement
Sensory Profile 2 Test, Social Responsiveness Scale 2, and Canadian occupational Performance Measure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving sensory diet through tele occupational therapy
Category
Rehabilitation
2
Description
Control group: receiving sensory diet through face-to-face occupational therapy
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran autism rehabilitation centers/Arman Shayan Occupational Therapy Clinic
Full name of responsible person
Doctor Mehdi Alizadeh
Street address
Arman Shayan Superspecialized Rehabilitation Center, Behnam Street, Ariashahr, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
2188639921
Phone
+98 21 4402 2820
Email
Mehdii.alizadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Administrator of Research and Technology
Street address
Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Yaman Street, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Navid Mirzakhani Araghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Shahid Beheshti Rehabilitation Faculty, infront of Bu Ali Hospital, Imam Hossein Square, Tehran, Iran