Comparison of the effect of family-based sensory diet program with and without tele occupational therapy on sensory processing pattern, social competency and occupational performance of children with autism spectrum disorder
Comparison of the effect of family-based sensory diet program with and without tele occupational therapy on sensory processing pattern, social competency and occupational performance of children with autism spectrum disorder
Design
A clinical trial with a control group, with parallel groups, single-blind, simple randomization using drawing method, control group: 16 autistic children, intervention group: 16 autistic children
Settings and conduct
The sensory diet intervention protocol is written for 4 sensory processing patterns. The samples in Tehran autism rehabilitation centers 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.The initial and final tests will be done by another occupational therapist who is proficient in the tests.
Participants/Inclusion and exclusion criteria
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)؛ age range: 4-10 years؛ not having neurological disorders such as epilepsy and other psychiatric disorders
Intervention groups
Intervention group: receiving a sensory regimen through tele occupational therapy/Control group: receiving a sensory regimen through face-to-face occupational therapy
Main outcome variables
sensory processing, social competency, occupational performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221128056651N2
Registration date:2022-12-21, 1401/09/30
Registration timing:registered_while_recruiting
Last update:2022-12-21, 1401/09/30
Update count:0
Registration date
2022-12-21, 1401/09/30
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
Comparison of the effect of family-based sensory diet program with and without tele occupational therapy on sensory processing pattern, social competency and occupational performance of children with autism spectrum disorder
Public title
Comparison of the effect of family-based sensory diet program with and without tele occupational therapy on sensory processing pattern, social competency and occupational performance of children with autism spectrum disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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)
age range: 4-10 years
Exclusion criteria:
neurological disorders such as epilepsy and other psychiatric disorders
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
The occupational therapist provides a pack of envelopes for the caregivers to choose a card from them. The arrangement of the cards will be random. 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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Next to Taleghani Hospital, Yaman Street
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-11-22, 1401/09/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.500
Health conditions studied
1
Description of health condition studied
autism spectrum disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
sensory processing pattern
Timepoint
immediately before and after the intervention and one month after the intervention
Method of measurement
sensory profile 2 test
2
Description
social competency
Timepoint
Before and after the intervention and one month after the intervention
Method of measurement
Social Responsiveness Scale 2
3
Description
occupational performance
Timepoint
Before and after the intervention and one month after the intervention
Method of measurement
Canadian occupational Performance Measure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving sensory diet through tele occupational therapy/ In the first phase, the sensory diet intervention protocol is written for 4 sensory processing patterns. The samples in Tehran autism rehabilitation centers are divided into two groups: in-person and tele occupational therapy. In the second phase, The intervetions 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. Families are taught the necessary things: awareness of their child's sensory pattern, its effect on behaviors, familiarization with how to perform activities and necessary environmental adaptations by the therapist, or watch videos with the therapist's explanation.
Category
Rehabilitation
2
Description
Control group: receiving sensory diet through face-to-face occupational therapy/ In the first phase, the sensory diet intervention protocol is written for 4 sensory processing patterns by expert panel. The samples in Tehran autism rehabilitation centers are divided into two groups: in-person and tele occupational therapy. In the second phase, The intervetions are done during 8 weeks. (12 sessions/ each session: 30 minutes) the sessions of in-person group are done in Tehran autism rehabilitation centers . A special sensory diet is given to each child during the sessions. Families are taught the necessary things: awareness of their child's sensory pattern, its effect on behaviors, familiarization with how to perform activities and necessary environmental adaptations by the therapist, or watch videos with the therapist's explanation.
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
Dr Mehdi Alizadeh
Street address
Arman Shayan Superspecialized Rehabilitation Center, Behnam Street, Ariashahr
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
Vice President of Research and Technology
Street address
SBMU, Next to Taleghani Hospital, Yaman Street
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