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The comparison of the effectiveness of Enhanced Milieu Teaching (EMT) delivered in face-to- face and telepractice formats on improving communication skills of children with Autism spectrum disorder

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History
# Registration date Revision Id
2 2021-07-08, 1400/04/17 189474
1 2021-07-07, 1400/04/16 189332
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  • Recruitment centers

    #1
    Name of recruitment center - English: Faculty of Rehabilitation Sciences, University of Iran
    Name of recruitment center - Persian: دانشکده علوم توانبخشی دانشگاه ایران
    Full name of responsible person - English: Salman Abdi
    Full name of responsible person - Persian: سلمان عبدی
    Street address - English: Madadkaran Ave., Shahnazari Blvd., Madar Square., Mirdamad
    Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 21 2222 7124
    Fax:
    Email: rehab@iums.ac.ir
    Web page address: https://rehab.iums.ac.ir/
    Name of recruitment center - English: Faculty of Rehabilitation Sciences - Iran University of Medical Sciences
    Name of recruitment center - Persian: دانشکده علوم توانبخشی - دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Salman Abdi
    Full name of responsible person - Persian: سلمان عبدی
    Street address - English: Maddakaran Alley, Shah Nazari St., Madar Square, Mirdamad Blvd., Tehran.
    Street address - Persian: تهران، میرداماد، خیابان شاه نظری، کوچه مددکاران.
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1545913487
    Phone: +98 21 2222 7124
    Fax:
    Email: rehab@iums.ac.ir
    Web page address: https://rehab.iums.ac.ir/

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Salman Abdi
    Full name of responsible person - Persian: سلمان عبدی
    Street address - English: Madadkaran Ave., Shahnazari Ave., Madar Square., Mirdamad
    Street address - Persian: میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۳۴۸۷ - ۱۵۴۵۹
    Phone: +98 21 2222 7124
    Fax:
    Email: rehab@iums.ac.ir
    Web page address: https://rehab.iums.ac.ir/

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Salman Abdi
    Full name of responsible person - Persian: سلمان عبدی
    Street address - English: Madadkaran Ave., Shahnazari Ave., Madar Square., Mirdamad
    Street address - Persian: میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 14665-354
    Phone: +98 21 2222 7124
    Fax:
    Email: rehab@iums.ac.ir
    Web page address: https://rehab.iums.ac.ir/

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Salman Abdi
    Full name of responsible person - Persian: سلمان عبدی
    Position - English: PHD candidate in speech and language pathology
    Position - Persian: دانشجوی دکترای تخصصی گفتاردرمانی
    Latest degree: master
    Area of specialty/work: 75
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: DolatAbad, Abu Saeed Street 24 meters, Abu Saeed 39, No. 28
    Street address - Persian: دولت آباد، 24 متری ابوسعید، ابوسعید 39، پلاک 28
    City - English: Karaj
    City - Persian: کرج
    Province: Alborz
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3136776558
    Phone: +98 26 3270 8659
    Mobile: +98 901 321 3415
    Fax:
    Email: salmanabdi.slp@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Leila Ghelichi
    Full name of responsible person - Persian: لیلا قلیچی
    Position - English: Assistant Professor of Speech Therapy
    Position - Persian: استادیار گفتاردرمانی
    Latest degree: phd
    Area of specialty/work: 75
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Maddakaran Alley, Shah Nazari St., Madar Square, Mirdamad Blvd., Tehran
    Street address - Persian: تهران، میرداماد، خیابان شاه نظری، کوچه مددکاران.
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 15459-13487
    Phone: +98 21 2222 7124
    Mobile: +98 912 485 2699
    Fax:
    Email: lghelichi@gmail.com
    Web page address:

Protocol summary

Study aim
The comparison of the effectiveness of Enhanced Milieu Teaching (EMT) delivered in face-to- face and telepractice formats on improving communication skills of children with Autism spectrum disorder
Design
Clinical trial with control group, one-way blind, using simple randomization method for 20 patients
Settings and conduct
Children with autism are the study population and autistic children referred to speech therapy clinics in Tehran are the study sample. Random sampling method will be used to select the subjects. To determine the sample size, in a pilot study, we will implement intervention programs on 20 children with autism spectrum disorder (two groups of 10 children). After collecting and analyzing the information, the sample size will be determined. This study will be conducted as a one-way randomized clinical trial in which the evaluators do not know the status of intervention groups.
Participants/Inclusion and exclusion criteria
Having definitive diagnosis of autism based on the psychiatrist's clinical judgment and the Gilliam Autism Diagnostic Scale - Second Edition (Garz-2). Being 3–6 years old. Having verbal imitation skill. Having less than a hundred functional words. Having no neurological problems such as cerebral palsy, seizures, and brain injuries. Having no sensory problems such as obvious hearing loss or visual impairment that cannot be compensated by assistive devices. Being a monolingual Farsi-speaking
Intervention groups
The intervention group receives EMT online via video call and the control group receives EMT in person through routine treatments.
Main outcome variables
Children's communication skills including communication intentions, frequency of communication, means of communication, non-verbal communication, mean length of utterance, expressive and receptive vocabulary.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210507051213N1
Registration date: 2021-07-07, 1400/04/16
Registration timing: registered_while_recruiting

Last update: 2021-07-08, 1400/04/17
Update count: 1
Registration date
2021-07-07, 1400/04/16
Registrant information
Name
Salman Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3270 8659
Email address
salmanabdi.slp@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of Enhanced Milieu Teaching (EMT) delivered in face-to- face and telepractice formats on improving communication skills of children with Autism spectrum disorder
Public title
The comparison of the effectiveness of Enhanced Milieu Teaching (EMT) delivered in face-to- face and telepractice formats on improving communication skills of children with Autism spectrum disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having definitive diagnosis of autism based on the psychiatrist's clinical judgment and the Gilliam Autism Diagnostic Scale - Second Edition (Garz-2). Being 3–6 years old. Having verbal imitation skill . Having less than a hundred functional words.
Exclusion criteria:
Having neurological problems such as cerebral palsy, seizures, and brain injuries that are identified through observation, examination as well as the use of the child's history and medical records. Having sensory problems such as obvious hearing loss or visual impairment that cannot be compensated by assistive devices. Being Bilingual.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
We use an online random number sequence generator (random.org; Haahr, 2010) to randomly allocate participants to intervention group (receiving online EMT) or control group (receiving face-to- face EMT). Haahr M. (2010). Random.org: True Random Number Service. Available at: http://www.random.org (accessed July 3, 2021)
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, assessors evaluate the clients before, during, and after follow-up, without knowing which treatment group each child is assigned to. Evaluators are not among the researchers in this study.
Placebo
Not used
Assignment
Parallel
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
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
3136776558
Approval date
2021-03-15, 1399/12/25
Ethics committee reference number
IR.IUMS.REC.1399.1423

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
Children's communication skills including communication intentions, frequency of communication, means of communication, non-verbal communication, mean length of utterance, expressive and receptive vocabulary.
Timepoint
Evaluation of communication variables before the intervention, after the intervention and two months after the intervention (the follow-up stage)
Method of measurement
Structured observation and MacArthur-Bates Communicative Development Inventories

Secondary outcomes

empty

Intervention groups

1

Description
Arranging the environment: Providing online parent training to structure the child's daily routine in order to form routines, limiting the environment, waiting for the child to ask for help, giving the child what he/she needs, and talking about the object's features.
Category
Rehabilitation

2

Description
Play and participation: Providing online parent training to choose interesting and fun toys, to join the child through active play with toys of his/her choice, and to teach activities and stages of the target play level to the child
Category
Rehabilitation

3

Description
Intervention group: Attention and responsiveness: Providing online parent training to sit face to face with the child, to follow the child's inner driver and to respond to all the child's communication
Category
Rehabilitation

4

Description
Intervention group: imitating and modeling: Providing online parent training to imitate the child's non-verbal activities and to provide language modeling through verbal description of the child's activities
Category
Rehabilitation

5

Description
Control group: Arranging the environment: Providing in-person parent training to structure the child's daily routine in order to form routines, limiting the environment, waiting for the child to ask for help, giving the child what he/she needs, and talking about the object's features.
Category
Rehabilitation

6

Description
Control group: Providing in-person parent training to choose interesting and fun toys, to join the child through active play with toys of his/her choice, and to teach activities and stages of the target play level to the child
Category
Rehabilitation

7

Description
Control group: Attention and responsiveness: Providing in-person parent training to sit face to face with the child, to follow the child's inner driver and to respond to all the child's communication
Category
Rehabilitation

8

Description
Control group: Intervention group: imitating and modeling: Providing in-person parent training to imitate the child's non-verbal activities and to provide language modeling through verbal description of the child's activities
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Rehabilitation Sciences - Iran University of Medical Sciences
Full name of responsible person
Salman Abdi
Street address
Maddakaran Alley, Shah Nazari St., Madar Square, Mirdamad Blvd., Tehran.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
Email
rehab@iums.ac.ir
Web page address
https://rehab.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Salman Abdi
Street address
Madadkaran Ave., Shahnazari Ave., Madar Square., Mirdamad
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 2222 7124
Email
rehab@iums.ac.ir
Web page address
https://rehab.iums.ac.ir/
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
Salman Abdi
Position
PhD candidate in speech and language pathology
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
DolatAbad, Abu Saeed Street 24 meters, Abu Saeed 39, No. 28
City
Karaj
Province
Alborz
Postal code
3136776558
Phone
+98 26 3270 8659
Fax
Email
salmanabdi.slp@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Ghelichi
Position
Assistant Professor of Speech Therapy
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Maddakaran Alley, Shah Nazari St., Madar Square, Mirdamad Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Fax
Email
lghelichi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Salman Abdi
Position
PHD candidate of speech and language pathology
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
No. 28, abosaid 39 Allay, 24metri abosaid Blvd, Dolatabad, Karaj Town
City
Alborz
Province
Alborz
Postal code
3136776558
Phone
+98 26 3270 8659
Fax
Email
salmanabdi.slp@gmail.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
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
Individual Participant Data (IPD) Study protocol Statistical analysis map Informed consent form Clinical study report
When the data will become available and for how long
Documentation will be available 3 months after the results are published.
To whom data/document is available
Academic Researchers Speech Therapists
Under which criteria data/document could be used
Data, analyzes, clinical study reports and treatment protocols for academic studies Therapeutic protocol for use in clinical work
From where data/document is obtainable
Salman Abdi Iran School of Rehabilitation Sciences salmanabdi.slp@gmail.com 09013213415
What processes are involved for a request to access data/document
Electronic correspondence or telephone call with the researcher, providing reasons for accessing the data or protocol
Comments
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