Development of serious game-based system for training social interaction to children with mild autism
Design
A before and after study without a control group on 30 children with mild autism, without blinding. Without randomization and with available sampling method
Settings and conduct
A total of 30 children with mild autism who meet the conditions for entering the study will be selected and included in the study from among those referred to the Brain and Cognition Clinic of Iran University of Medical Sciences. During an orientation session, explanations will be provided to the children and their parents regarding the purpose of the study and the steps involved. During this session, the children's parents and therapists are asked to complete the social skills profile questionnaire for each child. The children must use the game for three months according to the doctor's prescription, and at the end, this questionnaire will be completed for them again.
Participants/Inclusion and exclusion criteria
Participants must be between 6 and 12 years old to enter the study.
A specialist doctor has diagnosed and confirmed that the child has mild autism.
Participants should be at least average in IQ.
Participants must be at least at an intermediate level in terms of verbal and behavioral ability.
Participants do not have disabilities in the upper limbs.
Participants do not have any other mental or cognitive problems.
The parents and guardians of the children have consented to participate in the study and completed the informed consent form.
Intervention groups
We ask the study participants to play the game as prescribed by the doctor after participating in the briefing session for 3 months, three days a week and at least 45 minutes each time at home. The control group will not be used in this study.
Main outcome variables
Autism social skills profile test scores
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230416057917N1
Registration date:2023-08-15, 1402/05/24
Registration timing:prospective
Last update:2023-08-15, 1402/05/24
Update count:0
Registration date
2023-08-15, 1402/05/24
Registrant information
Name
Tahere Talebi Azadboni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4222 7642
Email address
tahere_22may@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development of serious game-based system for training social interaction to children with mild autism
Public title
Investigating the impact of serious game of training social interactions on children with mild autism
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 6 to 12 years
Diagnosis of mild autism by a specialist doctor
At least average IQ
Verbal and behavioral ability at least at an intermediate level
Lack of disability in the upper limbs of the body
Not suffering from other mental or cognitive problems
Exclusion criteria:
Adults with autism
Children with mild and severe autism
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
shahid hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
14665354
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.IUMS.REC.1402.281
Health conditions studied
1
Description of health condition studied
mild autism
ICD-10 code
F84. 0
ICD-10 code description
utistic disorder
Primary outcomes
1
Description
Autism Social Skills Profile Test
Timepoint
At the beginning of the study and after three months
Method of measurement
The measurement of this variable is done using the standard autism social skills profile questionnaire. This 48-question questionnaire was created solely to plan treatment, determine the progress of treatment and to measure a wide range of social behaviors of children and adolescents with autism spectrum disorder in the age range of six to 17 years, and it is particularly sensitive to the changes caused by treatment. . The said questionnaire can be completed by the parent, teacher and any other adult who is familiar with the child's social behavior. It takes fifteen to twenty minutes to complete, and the questions are graded on a four-point Likert scale (never: one, rarely: two, often: three, and always: four). Higher scores indicate more positive social behaviors. This test has been translated and validated in Farsi. The test is performed by a neurologist and the parents of the sample children after the briefing session as the beginning of the study at the brain and cognition clinic affiliated to Iran University of Medical Sciences. At the end of the 3 months of the study, the participants will be tested again.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We ask the participants of the study to play parts of the game as prescribed by a specialist doctor after participating in the briefing session for 3 months, three days a week and at least 45 minutes each time at home. The results of each time the game is played, which is considered as points, will be recorded in the game along with the duration of the game. This game is a mobile game (based on Android) by the research team and after a systematic review of the existing games and the impact They will be designed in such a way that the proposed game includes a series of small games and each of these small games will be related to one aspect of social skills.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Brain and Cognition Clinic affiliated to Iran University of Medical Sciences
Full name of responsible person
tahere talebi
Street address
No. 33, Valiasr St., East Zaratasht
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8880 2063
Fax
Email
bcclinic95@gmail.com
Web page address
https://bcclinic.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farahnaz Sadoughi
Street address
No. 4, Faculty of Management and Medical Information, Rashid Yasmi St, Valiasr St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 8879 4301
Email
sadoughi.f@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farahnaz Sadoughi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
No. 4, Faculty of Management and Medical Information, Rashid Yasmi St, Valiasr St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 8879 4301
Email
sadoughi.f@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farahnaz Sadoughi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
No. 4, Faculty of Management and Medical Information, Rashid Yasmi St., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8879 4301
Email
sadoughi.f@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tahere Talebi Azadboni
Position
PhD. Student
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
No. 4, Faculty of Management and Medical Information, Rashid Yasmi St.,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8878 2919
Email
tahere_22may@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The IPD after the end of the study will be reported in a non-identifiable way in the report of the intervention result in the thesis and extracted articles.
The full report of the clinical study and its results will be reported in the form of the effect of serious play on the social interactions of children with mild autism at the end of the work.
When the data will become available and for how long
2024 , March
To whom data/document is available
Researchers interested in the subject of this study
Under which criteria data/document could be used
For use in selection or serious game design
From where data/document is obtainable
Professor Farahnaz Sadoughi
What processes are involved for a request to access data/document