The effectiveness of the intervention on the sensory pattern and occupational performance of children with autism spectrum disorder
Design
A clinical trial ,a control group with randomized one way blinded identical groups.
Numbered envelopes for randomization.
Settings and conduct
Samples from Arman shayan Rehabilitation . Assessments are in the form of a questionnaire and an interview. During the intervention sessions, the researcher teaches parents how to play the selected games that are appropriate to the
assessments along with the necessary considerations appropriate to the child's sensory conditions and needs to play at home in the presence of the child. Parents are then asked to play games at home. The duration of the intervention is 3 days a week for 8 weeks. During the week, the researcher communicates with the family by virtual environment. It should be noted that this book has been translated into Persian. The intervention group will receive these games in addition to the usual rehabilitation programs supervised by the project manager, and the control group will receive only the usual rehabilitation services according to their schedule during these 8 weeks. At the end of the intervention period, the final evaluation is performed again to assess the effectiveness of the intervention.
Participants/Inclusion and exclusion criteria
Children with ASD at the age of 3 to 6 years
Existence of sensory processing disorder
No history of seizures or epilepsy
No accompanying physical problems
Gars score below 80
Parents of children with at least a diploma literacy level
Intervention groups
intervention group teaching sensory plays in addition to usual treatments
control group just usual treatment
Main outcome variables
Occupational performance , Sensory processing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211114053055N1
Registration date:2022-02-02, 1400/11/13
Registration timing:prospective
Last update:2022-02-02, 1400/11/13
Update count:0
Registration date
2022-02-02, 1400/11/13
Registrant information
Name
Negar Baharian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2290 7189
Email address
baharian.negar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of family centered play-based interventions on sensory pattern and occupational performance of children with autism spectrum disorder
Public title
Effectiveness of family centered play-based interventions on sensory pattern and occupational performance of children with autism spectrum disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with autism spectrum disorder at the age of 3 to 6 years
Existence of sensory processing disorder
No history of seizures or epilepsy
No accompanying physical problems
GARS score below 80 (Autism level 1 and 2)
Parents of children must have at least a diploma level of education.
Exclusion criteria:
Lack of parents or child cooperation at any stage of the study
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
We will have envelopes A and B for the number of people we have in the study (48). Each of the eligible participants will enter the intervention group by selecting envelope A and the control group by selecting envelope B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Eligible families are given the necessary explanations about the study and are assured that their information will be kept with the study team. Participants' families will be explained that assessments will be performed for their child, and they may then be taught games to play at home, reassuring them that there will be no harm or danger to any of them. The study process will not be relevant to their child
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Department of Occupational Therapy, Tehran University of Medical Sciences, Corner of Safi Alisha, Above Pich Shemiran, Enghelab St.
City
TEHRAN
Province
Tehran
Postal code
11489-65111
Approval date
2021-12-05, 1400/09/14
Ethics committee reference number
IR.TUMS.FNM.REC.1400.160
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
Occupational performance
Timepoint
After two months and after the end of the intervention
Method of measurement
Canadian Occupational Performance Measure
2
Description
sensory processing
Timepoint
After two months and after the end of the intervention
Method of measurement
Canadian Occupational Performance Measure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the researcher teaches the parents how to play the selected games that are in accordance with the evaluations performed and the reported sensory pattern of the child, along with the necessary considerations in accordance with the conditions and sensory needs of the child to play at home in the presence of the child. This training will be in person and with visual instructions and written explanations for home implementation. It should be emphasized that the presence of the child in weekly training sessions and troubleshooting is mandatory, and although in addition to meeting sensory needs, strengthening mutual attention and engaging children is one of the primary goals of all selected games, but corrections and adaptations to conditions and environment The game is tailored to the needs of each child in order to play the games more correctly and completely at home and the cooperation of as many children as possible is suggested to the parents by the researcher. Parents are then asked to play games at home. The duration of the intervention is 3 days a week for 8 weeks. During the week, the researcher communicates with the family by phone or video and follows the process of how the games are played at home and gives feedback to the family. The accuracy of the games will be measured by the parents through a checklist prepared by the researcher in consultation with the research team. The games will be selected from the book of early intervention games written by Ms. Barbara Sher.
Category
Rehabilitation
2
Description
Control group: During the intervention, the control group will receive their other rehabilitation programs (including speech therapy, etc.) according to the previous procedure. The primary and secondary evaluations of this study will be performed for them as well.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Arman Shayan Rehabilitation Clinic
Full name of responsible person
Negar Baharian
Street address
Arman Shayan Rehabilitation Complex, in front of Tarbiat Park, Ayatollah Kashani Highway, Behnam St.
City
Tehran
Province
Tehran
Postal code
1471715581
Phone
+98 21 4402 2820
Email
baharian.negar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Street address
Department of Occupational Therapy, Tehran University of Medical Sciences, Corner of Safi Alisha, Above Pich Shemiran, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 8798
Email
praji@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Department of Occupational Therapy, Tehran University of Medical Sciences, Corner of Safi Alisha, Above Pich Shemiran, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
009877538798
Email
praji@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Department of Occupational Therapy, Tehran University of Medical Sciences, Corner of Safi Alisha, Above Pich Shemiran, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
009877538798
Email
praji@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Negar Baharian
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Department of Occupational Therapy, Tehran University of Medical Sciences, Corner of Safi Alisha, Above Pich Shemiran, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
009877538798
Email
baharian.negar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available