Protocol summary
-
Study aim
-
Examining the effect of training pretend play on theory of mind in children with autism spectrum disorder
-
Design
-
Clinical trial with a control group, double-blind, randomized, a sealed envelope will be used for randomization.
-
Settings and conduct
-
The study will be performed on 20 children with an autism spectrum disorder in Ahvaz. The assessor of the outcome measures will be blind about the groups that children will be allocated.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Age range 9-5 years; Definitive diagnosis of autism spectrum disorder based on the opinion of a psychiatrist; Gilliam-Garz diagnostic test with a score of 30 or higher to diagnose mild to moderate autism spectrum disorder; Assessing the history of the child's play in the form of interviews with the mother and also observing the child's free play will be examined to assess the level of pretend to play in the child, the literacy of reading and writing in Persian for parents.
-
Intervention groups
-
The experimental group is a total of 20 people who will be divided into two groups of 10 people. The first intervention group, in addition to common interventions, will undergo 20 sessions of 45 to 60 minutes of pretend play training with a identiplay approach and relying on the theory of mind. The form is prepared from two series of play tools and after the scenario is done by the child researcher, the child must be able to imitate the play scenario and if the next level is done correctly, the next level will be presented to the child, but the second intervention group,receive pretend play without relying on theory of mind, while the control group, which is 10 people, only receive common interventions..
-
Main outcome variables
-
Improving the theory of mind in children with autism spectrum disorder
General information
-
Reason for update
-
In the initial protocol, due to the fact that it was in the form of a thesis and coincided with the Corona situation, the families did not go to the clinic for the desired study due to the conditions, but considering that the thesis with a smaller number (6 people) in the defense group Currently, there is an opportunity to include the third group in the study of this clinical trial in a more accurate and strong way and to answer the questions more precisely.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20210227050518N1
Registration date:
2021-08-14, 1400/05/23
Registration timing:
prospective
Last update:
2023-01-14, 1401/10/24
Update count:
1
-
Registration date
-
2021-08-14, 1400/05/23
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-08-23, 1400/06/01
-
Expected recruitment end date
-
2021-09-21, 1400/06/30
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Examining the effect of training pretend play based on theory of mind in children with autism spectrum disorder
-
Public title
-
Examining the effect of training pretend play based on theory of mind in children with autism spectrum disorder
-
Purpose
-
Education/Guidance
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Age range 9-5 years
Definitive diagnosis of autism spectrum disorder based on the opinion of a psychiatrist
Gilliam-Garz diagnostic test with a score of 30 or higher to diagnose mild to moderate autism spectrum disorder
Assessing the history of the child's play in the form of interviews with the mother and also observing the child's free play will be examined to assess the level of pretend to play in the child, performing 3 examples of pretend play that the child can show 3 consecutive or more pretending behaviors in the play
the literacy of reading and writing in Persian for parents
Exclusion criteria:
Lack of normal hearing and vision
-
Age
-
From 5 years old to 9 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
30
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Random sequencing will be done through a table of random numbers in such a way that from the second page of the third column of the table of random numbers with a sequence of 3 numbers whose last digit is even as an experimental group and numbers whose last digit is odd as a control group Is selected. Concealment of random allocation is sealed through the envelope by preparing a number of envelopes and writing the numbers of the table, experimental group, and control on the sheet and placing them in the envelope, respectively, and in order to maintain a random sequence, on external surfaces. Envelopes are numbered in the same way. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Pre-test and post-test will be performed by a trained assessor who is not aware of the patients' group.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-01-31, 1399/11/12
-
Ethics committee reference number
-
IR.UT.IRICSS.REC.1399.004
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
-
Theory of Mind
-
Timepoint
-
Beginning and end of the study
-
Method of measurement
-
Theory of mind inventory, Sally-Anne and smartiz task, penny-hiding game
Secondary outcomes
1
-
Description
-
Task-based theory of mind
-
Timepoint
-
Beginning and end of the study
-
Method of measurement
-
penny-hiding game, Sally-Anne task and Smartiz task
2
-
Description
-
Level of theory of mind from family perspective
-
Timepoint
-
Beginning and end of the study
-
Method of measurement
-
Theory of mind inventory
Intervention groups
1
-
Description
-
Intervention group: Children after pre-test will undergo 20 sessions of pretend play training with a identiplay approach based on theory of mind for 45 minutes and 4 times a week and the current treatment approach. Sessions will be held individually.
-
Category
-
Rehabilitation
2
-
Description
-
Control group: They will receive standard rehabilitation therapies such as occupational therapy, cognitive rehabilitation, and speech therapy.
-
Category
-
Rehabilitation
3
-
Description
-
Intervention group: After the pre-test, the children undergo 20 sessions of pretend play training without the theory of mind approach for 45 minutes, 4 times a week, and regular rehabilitation treatments. Meetings are held individually.
-
Category
-
Rehabilitation
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Institute for cognitive science studies
-
Proportion provided by this source
-
1
-
Public or private sector
-
Private
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Other
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
-
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
-
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
-
In the form of an article
-
When the data will become available and for how long
-
In the form of an article
-
To whom data/document is available
-
In the form of an article
-
Under which criteria data/document could be used
-
In the form of an article
-
From where data/document is obtainable
-
In the form of an article
-
What processes are involved for a request to access data/document
-
In the form of an article
-
Comments
-