Investigating and comparing virtual reality and Risperidone and the behavioral and social problems of children with autism.
One of the problems of children with autism is social and behavioral disorders that parents are looking for. The aim of this study is to create a non-invasive solution to solve the social and behavioral problems of children with autism.
Design
Exprimental
In this study, individuals who were diagnosed with autism were randomly divided into two intervention groups and one control group. The size of each group is 10 people.
Settings and conduct
Children with autism who came to the Center for Andisheh and Raftar. Virtual reality intervention sessions 6 months a week were two 45-minute sessions. The other group was treated with risperidone for 6 months. The control group did not receive any intervention. All parents of the clients completed the consent to participate in the research.
Participants/Inclusion and exclusion criteria
Diagnosis of autism according to the Gilliam test, clinical interview based on DSM-5.
Age (in the age range of 4 to 12 years) Of course, this tool is applicable until the age of 16, but the researcher has chosen this age range because most of the clients are in this age range.
The children who participated in this study participated in this study with the consent obtained from their parents.
Intervention groups
Children with autism who take virtual reality
Children with autism who took Rsperidone.
Main outcome variables
Behavioral problems were measured before and after drug intervention and virtual reality intervention.
Social problems were measured before and after drug intervention and virtual reality intervention.
General information
Reason for update
Acronym
Virtual Reality and Autism
IRCT registration information
IRCT registration number:IRCT20191113045429N1
Registration date:2020-06-15, 1399/03/26
Registration timing:retrospective
Last update:2020-06-15, 1399/03/26
Update count:0
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
Sakineh Soltani kouhbanani
Name of organization / entity
The Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3880 5892
Email address
s.soltani@um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-11-14, 1398/08/23
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2019-11-14, 1398/08/23
Trial completion date
2019-11-14, 1398/08/23
Scientific title
Comparing the effect of Risperidone, Virtual Reality on Social Skills, and Behavioral difficulties in Children with Autism
Public title
Virtual Reality and Autism
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having autism based on Gilliam test, clinical interview and DSM-5 components
Minimum age 4 years and maximum age 12 years
Exclusion criteria:
parents dont agreed
children who have comotbity disorder bisides autism
Age
From 4 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
20
More than 1 sample in each individual
Actual sample size in each individual:
20
Each sample takes only one intervention. For example, 10 people who receive virtual reality intervention and 10 people who receive Risperidone medication.
Randomization (investigator's opinion)
Randomized
Randomization description
People with autism were randomly assigned to three groups (virtual reality,ٌRisperidone therapy, and control group). Thirty names were written by chance, and the first 10 people were randomly selected from the Virtual Reality Process, and the second 10 people from the Risperidone group and the third 10 people from the group were waiting for the group to receive no intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Because the tool is built for the first time, the effectiveness of reducing social and behavioral problems is assessed
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ferdowsi University Of Mashhad
Street address
Azadi Ave.Ferdowsi University Of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Approval date
2019-11-14, 1398/08/23
Ethics committee reference number
IR.UM.REC.1398.129
Health conditions studied
1
Description of health condition studied
Autism Disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Evaluates the behavioral problems of children with autism through a questionnaire.
Timepoint
The first group had two virtual reality training sessions per week, the second group received drug therapy every day, but pre-test and post-test measurements were performed only at the beginning and end of the intervention period (6 months).
Method of measurement
Behavioral Problems Questionnaire
2
Description
Evaluates the social problems of children with autism through a questionnaire.
Timepoint
The first group had two virtual reality training sessions per week, the second group received drug therapy every day, but pre-test and post-test measurements were performed only at the beginning and end of the intervention period (6 months).
Method of measurement
Social Problem Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Risperidone drug therapy is the first intervention in a group. The intervention lasted 6 months. The first group to receive drug treatment under the supervision of a psychiatrist received Risperidone medication. First, behavioral and social problems were taken before the test, and after 6 drug treatments, behavioral and social problems were taken twice, and this difference shows the effect of drug therapy on reducing behavioral and social problems.
Category
Treatment - Drugs
2
Description
In the second virtual reality intervention group, behavioral and emotional disorders were taken before the test, and two sessions a week, in which a 45-minute virtual reality training program was taught and lasted for 6 months. In this intervention model, a number of animation images that Communication skills training is done in a three-dimensional way for a child with autism, and at the end of 6 months of post-test intervention, behavioral and emotional disorders were performed.
Category
Treatment - Devices
3
Description
The control group did not receive any referrals. Only pre-tests completed behavioral and social problems and were placed on a waiting list, and after 6 months they completed the behavioral and social problem questionnaire again.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Andisheh Raftar Clinic
Full name of responsible person
Sakineh Soltani Kouhbanani
Street address
Azadi Ave. Ferowsi University Of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 3000
Email
s.soltani@um.ac.ir
2
Recruitment center
Name of recruitment center
Andisheh Raftar Clinic
Full name of responsible person
Sakineh Soltani Kouhbanani
Street address
Azadi Ave. Ferdowsi University of mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 3000
Email
s.soltani@um.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President For Research and Technology Of Ferdowsi University Of Mashhad
Full name of responsible person
Ahmad Reza Bahrami
Street address
Azadi Ave.Ferdowsi University Of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91777948974
Phone
+98 51 3880 3000
Email
s.soltani@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Private
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
Vice President For Research and Technology Of Ferdowsi University Of Mashhad
Full name of responsible person
Sakineh Soltani Kouhbanani
Position
Professer
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Azadi Ave. Ferdowsi university of mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 3000
Email
s.soltani@um.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vice President For Research and Technology Of Ferdowsi University Of Mashhad
Full name of responsible person
Sakineh Soltani Kouhbanani
Position
Professer
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Azadi Ave. Ferdowsi university of mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 3000
Email
s.soltani@um.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Vice President For Research and Technology Of Ferdowsi University Of Mashhad
Full name of responsible person
Sakineh Soltani Kouhbanani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Azadi AVE. FERDOWSI UNIVERSITY OF MASHHAD
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 3000
Email
s.soltani@um.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparing the effect of Risperidone, Virtual Reality and Risperidone on Social Skills, and Behavioral difficulties in Children with Autism
When the data will become available and for how long
1 year later in 2021
To whom data/document is available
every one
Under which criteria data/document could be used
Article
From where data/document is obtainable
s.soltani@um.ac.ir
What processes are involved for a request to access data/document