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
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:2021-07-07, 1400/04/16
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
13th floor, Block A, Simaye Iran Street, between South Flamek and Zarafshan, Qods Town(West)
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, University of Iran