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Protocol summary
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.
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.
The study will be performed on 1020 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.
مطالعه روی 10 کودک دارای اختلال طیف اتیسم شهر اهواز انجام خواهد شد. ارزیاب نیز در مورد شرکت کنندگان ازمایش و کنترل کور خواهد شد .
مطالعه روی 20 کودک دارای اختلال طیف اتیسم شهر اهواز انجام خواهد شد. ارزیاب نیز در مورد شرکت کنندگان ازمایش و کنترل کور خواهد شد .
مطالعه روی 1020 کودک دارای اختلال طیف اتیسم شهر اهواز انجام خواهد شد. ارزیاب نیز در مورد شرکت کنندگان ازمایش و کنترل کور خواهد شد .
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.
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.
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.
"دامنهی سنی 9-5 سال"
"تشخیص قطعی اختلال طیف اتیسم بر اساس نظر روانپزشک"
"آزمون تشخیصی گیلیام-گارز و داشتن نمره لازم 30 به بالا جهت تشخیص سطح خفیف و متوسط اختلال طیف اتیسم"
"برخورداری از شنوایی و بینایی طبیعی"
"ارزیابی تاریخچه¬ی بازی کودک در قالب مصاحبه با مادر و همچنين مشاهده بازي آزاد كودك بررسي گشته تا سطح بازی وانمودي در کودک ارزیابی شود، انجام 3 نمونه بازی وانمودی که کودک بتواند 3 مورد متوالی یا بیشتر از رفتار های وانمودین در بازی نشان دهد"
"برای سواد خواندن و نوشتن و تسلط به زبان فارسی والدین"
"دامنهی سنی 9-5 سال"
"تشخیص قطعی اختلال طیف اتیسم بر اساس نظر روانپزشک"
"آزمون تشخیصی گیلیام-گارز و داشتن نمره لازم 30 به بالا جهت تشخیص سطح خفیف و متوسط اختلال طیف اتیسم"
"برخورداری از شنوایی و بینایی طبیعی"
"ارزیابی تاریخچه¬ی بازی کودک در قالب مصاحبه با مادر و همچنين مشاهده بازي آزاد كودك بررسي گشته تا سطح بازی وانمودي در کودک ارزیابی شود.
"برای سواد خواندن و نوشتن و تسلط به زبان فارسی والدین"
"دامنهی سنی 9-5 سال" "تشخیص قطعی اختلال طیف اتیسم بر اساس نظر روانپزشک" "آزمون تشخیصی گیلیام-گارز و داشتن نمره لازم 30 به بالا جهت تشخیص سطح خفیف و متوسط اختلال طیف اتیسم" "برخورداری از شنوایی و بینایی طبیعی" "ارزیابی تاریخچه¬ی بازی کودک در قالب مصاحبه با مادر و همچنين مشاهده بازي آزاد كودك بررسي گشته تا سطح بازی وانمودي در کودک ارزیابی شود، انجام 3 نمونه بازی وانمودی که کودک بتواند 3 مورد متوالی یا بیشتر از رفتار های وانمودین در بازی نشان دهد". "برای سواد خواندن و نوشتن و تسلط به زبان فارسی والدین"
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.
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..
InThe 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 the routine treatment approachcommon interventions, the experimental group undergoeswill undergo 20 sessions, each session of 45 to 60 minutes, teaching pretending to of pretend play training with ana identiplay approach to the play and relying on the theory of mind, that. The form is modified for teachingprepared 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, in which two series of a game toy will be prepared and after performingwhile 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, which is 10 people, only receive only the routine treatment approachcommon interventions..
گروه آزمایش علاوه بر مداخلات رایج، تحت 20 جلسه 45 تا 60 دقیقه ای، آموزش بازی وانمودی با رویکرد همسان بازی و با تکیه بر تئوری ذهن قرار می گیرد بدین صورت که از ابزار بازی دو سری تهیه می شود و بعد از انجام دادن سناریو توسط محقق کودک باید بتواند سناریو بازی را تقلید کند و در صورت درست انجام دادن سطح بعدی به کودک ارائه می شود، در حالیکه گروه کنترل فقط مداخلات رایج را دریافت می کنند.
گروه آزمایش جمعا 20 نفر که به دو گروه 10 نفره تقسیم خواهند شد که گروه اول مداخله علاوه بر مداخلات رایج، تحت 20 جلسه 45 تا 60 دقیقه ای، آموزش بازی وانمودی با رویکرد همسان بازی و با تکیه بر تئوری ذهن قرار می گیرد، بدین صورت که از ابزار بازی دو سری تهیه می شود و بعد از انجام دادن سناریو توسط محقق کودک باید بتواند سناریو بازی را تقلید کند و در صورت درست انجام دادن سطح بعدی به کودک ارائه می شود ولی گروه دوم مداخله فقط بازی های وانمودی بدون تکیه بر تئوری ذهن دریافت می کنند در حالیکه گروه کنترل که 10 نفر می باشد، فقط مداخلات رایج را دریافت می کنند.
گروه آزمایش جمعا 20 نفر که به دو گروه 10 نفره تقسیم خواهند شد که گروه اول مداخله علاوه بر مداخلات رایج، تحت 20 جلسه 45 تا 60 دقیقه ای، آموزش بازی وانمودی با رویکرد همسان بازی و با تکیه بر تئوری ذهن قرار می گیرد، بدین صورت که از ابزار بازی دو سری تهیه می شود و بعد از انجام دادن سناریو توسط محقق کودک باید بتواند سناریو بازی را تقلید کند و در صورت درست انجام دادن سطح بعدی به کودک ارائه می شود، ولی گروه دوم مداخله فقط بازی های وانمودی بدون تکیه بر تئوری ذهن دریافت می کنند در حالیکه گروه کنترل که 10 نفر می باشد، فقط مداخلات رایج را دریافت می کنند.
General information
20
30
2030
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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.
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.
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در پروتکل اولیه به علت اینکه در قالب پایان نامه بود و با شرایط کرونا هم زمان شده بود خانواده ها به علت شرایط به کلینیک در جهت مطالعه مورد نظر مراجعه نمیکردند اما با توجه به اینکه پایان نامه با تعداد کمتر(6 نفر) در گروه دفاع شد در حال حاضر فرصت این وجود دارد که با وارد کردن گروه سوم به مطالعه این کارازمایی بالینی به صورت دقیق تر و قوی تر انجام گیرد و به طور دقیق تری به سوالات پاسخ داده شود
در پروتکل اولیه به علت اینکه در قالب پایان نامه بود و با شرایط کرونا هم زمان شده بود خانواده ها به علت شرایط به کلینیک در جهت مطالعه مورد نظر مراجعه نمیکردند اما با توجه به اینکه پایان نامه با تعداد کمتر(6 نفر) در گروه دفاع شد در حال حاضر فرصت این وجود دارد که با وارد کردن گروه سوم به مطالعه این کارازمایی بالینی به صورت دقیق تر و قوی تر انجام گیرد و به طور دقیق تری به سوالات پاسخ داده شود
Intervention groups
#1
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Rehabilitation
rehabilitaion
empty
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.
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.
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گروه مداخله:کودکان پس از پیش آزمون، تحت 20 جلسه آموزش بازی وانمودی بدون رویکرد تئوری ذهن به مدت 45 دقیقه، هفته ای 4 بار و درمانهای معمول توانبخشی قرار می گیرند. جلسات به صورت انفرادی برگزار می گردد.
گروه مداخله:کودکان پس از پیش آزمون، تحت 20 جلسه آموزش بازی وانمودی بدون رویکرد تئوری ذهن به مدت 45 دقیقه، هفته ای 4 بار و درمانهای معمول توانبخشی قرار می گیرند. جلسات به صورت انفرادی برگزار می گردد.
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Institute for cognitive science studies
Name of organization / entity - Persian: موسسه آموزش عالی علوم شناختی
Full name of responsible person - English: javad hatami
Full name of responsible person - Persian: جواد حاتمی
Street address - English: Phase 4 of Pardis City, Tehran, Iran
Street address - Persian: فاز 4 شهر پردیس، میدان عدالت، انتهای بلوار سفیر امید، بلوار علوم شناختی، بلوار شهید چمران
City - English: Pardis
City - Persian: پردیس
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1658344575
Phone: +98 21 7629 1130
Fax: +98 21 7629 1140
Email: ICSS@iricss.org
Web page address: http://www.iricss.org
contact.organization_id:
Name of organization / entity - English: Institute for cognitive science studies
Name of organization / entity - Persian: موسسه آموزش عالی علوم شناختی
Full name of responsible person - English: Javad Hatami
Full name of responsible person - Persian: جواد حاتمی
Street address - English: Phase 4 of Pardis City, Tehran, Iran
Street address - Persian: فاز 4 شهر پردیس، میدان عدالت، انتهای بلوار سفیر امید، بلوار علوم شناختی، بلوار شهید چمران
City - English: Pardis
City - Persian: پردیس
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1658344575
Phone: +98 21 7629 1130
Fax: +98 21 7629 1140
Email: ICSS@iricss.org
Web page address: http://www.iricss.org
contact.organization_id: Name of organization / entity - English: Institute for cognitive science studies Name of organization / entity - Persian: موسسه آموزش عالی علوم شناختی Full name of responsible person - English: javad hatamiJavad Hatami Full name of responsible person - Persian: جواد حاتمی Street address - English: Phase 4 of Pardis City, Tehran, Iran Street address - Persian: فاز 4 شهر پردیس، میدان عدالت، انتهای بلوار سفیر امید، بلوار علوم شناختی، بلوار شهید چمران City - English: Pardis City - Persian: پردیس Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1658344575 Phone: +98 21 7629 1130 Fax: +98 21 7629 1140 Email: ICSS@iricss.org Web page address: http://www.iricss.org
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
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:
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
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
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Autism Spectrum Disorder Treatment and Rehabilitation Centers