Investigating the effectiveness of remote training of the theory of mind in improving the social interactions of children with autism spectrum disorder level 1 compared to face-to-face training
Main Objective:
To determine the effectiveness of in-person training compared to remote training in Theory of Mind on improving social interactions in children with Autism Spectrum Disorder level 1.
Design
Clinical trial with 2 parallel groups, without blinding, randomized, on 28 patients. The closed envelope method will be used for randomization.
Settings and conduct
Theory of Mind (TOM) training for children with Autism Spectrum Disorder (ASD) will be conducted in government hospitals and centers, under the cover of Mashhad University of Medical Sciences. The effect of this training on the social skills of those who have been blinded in the research path of the evaluator and statistician and do not know which group the examined subjects belong to.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Be in the autistic range according to the GARS-3 questionnaire
2. The age of children should be between 6 and 9 years
3. Do not have any intelligence, hearing, vision or neurological problems other than ASD
Exclusion criteria:
1. Parents' lack of consent for their child's participation in the study
2. Observing signs of parents' inability to participate in exercises and perform them at home
Intervention groups
Two groups, one in-person and the other remote, will undergo a 20-session training over a 10-week period in Mind Reading concepts at 10 therapeutic levels, based on a reputable source (Hawkins et al., 1999; translated by Rezaei, 2020). The training sessions will be conducted individually.
Main outcome variables
social interactions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240305061172N1
Registration date:2024-04-08, 1403/01/20
Registration timing:prospective
Last update:2024-04-08, 1403/01/20
Update count:0
Registration date
2024-04-08, 1403/01/20
Registrant information
Name
Fatemeh Haresabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3189 2001
Email address
haresabadif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of remote training of the theory of mind in improving the social interactions of children with autism spectrum disorder level 1 compared to face-to-face training
Public title
Investigating the effectiveness of training of the theory of mind in improving the social interactions of children with autism spectrum disorder level 1
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Receiving a diagnosis of Autism Spectrum Disorder, level 1 by a psychiatrist
Being within the autistic range according to the GARS-3 questionnaire
Monolingual Persian speaker
The age of children should be between 6 and 9 years old
no presence of any intellectual, auditory, visual, or other neurocognitive problems except ASD, as determined through observation and reviewing files at centers, as well as interviews with parents
Exclusion criteria:
Parents' lack of consent for their child's participation in the study
Observing the signs of parents' inability to participate in exercises and perform them at home
Age
From 6 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the necessity of equal number of participants in two study groups, randomization will be done based on the blocked randomization method. For this, using the Randomization menu of the website of https://www.sealedenvelope.com (which provides researchers with a web-based block randomization tool) and considering random blocks of 2, 4 and 6 participants, the allocation of subjects to groups will be determined. For allocation concealment, Sequentially numbered, sealed, opaque envelopes (SNOSE) will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
According to the nature of the study, blinding is not possible. However, the evaluator and statistician will not know about the allocation of the subjects.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Speech therapy department, 2nd floor, Shahid Kharazmi educational building, University campus, Vakil Abad Blvd., Bahnar Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.MUMS.FHMPM.REC.1402.238
Health conditions studied
1
Description of health condition studied
Autism spectrum disorders
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
The score of an autistic child on the Sternberg Theory of Mind Test.
Timepoint
Evaluation before and after the intervention
Method of measurement
Theory of Mind Test - Sternmen
Secondary outcomes
1
Description
The score of an autistic child on the Garshasebi and Elliot (1990) Social Skills Questionnaire
Timepoint
Evaluation before and after the intervention
Method of measurement
The Garshasebi and Elliot (1990) Social Skills Questionnaire
2
Description
The score of an autistic child on the Communication Skills Checklist - Second Edition
Timepoint
Evaluation before and after the intervention
Method of measurement
The Communication Skills Checklist - Second Edition
3
Description
the assessment of informal social interaction behaviors
Timepoint
Evaluation before and after the intervention
Method of measurement
The assessment of informal social interaction behaviors
Intervention groups
1
Description
Intervention group: distance learning (online): Participants will be trained in mind reading concepts in 10 treatment levels for 20 sessions in 10 weeks based on a reliable source (Havlin et al., 1999; translated by Rezaei, 2019). (Number of sessions per week: 2 - Duration of each session: 20 minutes - Session audience: child + mother - Executive measures in each session: 1. Teaching exercises to the mother to guide the child in the online session and perform at home (daily for at least 45 minutes)2. Examining the video of the exercises and the mother's report on the exercises and the child's conditions at home3. Answering the mother's questions - mandatory items of each session: Mother's verbal report and at least 3 videos of 40-60 seconds (one of the best, one of the worst, and one of the usual) of performing exercises at home.
Category
Rehabilitation
2
Description
control group: face-to-face training (traditional method): Participants will be trained in mind reading concepts in 10 treatment levels for 20 sessions in 10 weeks based on a reliable source (Havlin et al., 1999; translated by Rezaei, 2019). (number of sessions per week: 1 - duration of each session: 40 minutes - session audience: mother + child - implementation measures in each session: 1. Performing exercises with the child2. Providing explanations of the exercises to the mother to perform at home3. Examining the mother's verbal report of the child's activity in the interval between sessions4. Answering mother's questions - the mandatory items of each session: Mother's verbal report of performing exercises at home
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive rehabilitation center
Full name of responsible person
Fatemeh Haresabadi
Street address
Ahmad Abad Blvd., Nurse St., 2
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3189 2001
Email
haresabadif@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Haresabadi
Street address
Department of Speech Therapy,Kharazmi building, university campus, Vakilabad Blvd, Bahonar Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3189 2001
Email
haresabadif@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Haresabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy,Kharazmi building, university campus, Vakilabad Blvd, Bahonar Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3189 2001
Fax
Email
haresabadif@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Haresabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy,Kharazmi building, university campus, Vakilabad Blvd, Bahonar Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3189 2001
Fax
Email
haresabadif@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Haresabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy,Kharazmi building, university campus, Vakilabad Blvd, Bahonar Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3189 2001
Fax
Email
haresabadif@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD