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 10 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, performing 3 examples of pretend to 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.
Intervention groups
In addition to the routine treatment approach, the experimental group undergoes 20 sessions, each session 45 to 60 minutes, teaching pretending to play with an identiplay approach to the play and relying on the theory of mind, that is modified for teaching theory of mind, in which two series of a game toy will be prepared and after performing the scenario by the researcher, children should imitate the play scenario, if children imitate correctly, then go to the next level. The control group will receive only the routine treatment approach.
Main outcome variables
Improving the theory of mind in children with autism spectrum disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210227050518N1
Registration date:2021-08-14, 1400/05/23
Registration timing:prospective
Last update:2021-08-14, 1400/05/23
Update count:1
Registration date
2021-08-14, 1400/05/23
Registrant information
Name
Fatemeh Rahmani
Name of organization / entity
Institute for Cognitive Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3321 3077
Email address
markazgolshan@gmail.com
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:
20
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Institute for Cognitive Sciences
Street address
No. 216, between Aban & Azar, khordad Ave, Golestan Blvd, Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6136939161
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Autism Spectrum Disorder Treatment and Rehabilitation Centers