Determining the effect of reference education on speech and language skills of patients with autism spectrum disorders
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, on 90 patients. Excel software will be used for randomization.
Settings and conduct
The present study is performed on all available samples that have been referred to rehabilitation and speech therapy centers in Tabriz during the research period and have inclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of autism spectrum disorders by a neurologist / Age of subjects is three to ten calendar years / Absence Other psychological and psychiatric disorders with the exception of autism/living with both parents/level of education of parents at least diploma/place of residence in Tabriz.
Exclusion criteria: Receiving other parallel rehabilitation and educational interventions during the intervention/absence of more than one session/presence of speech or number of words more than three or four words / sensory and Motor defects.
Intervention groups
All selected patients will be tested for Newsha and verbal imitation. These tests will also be performed on normal children. The results will be evaluated and compared with the results obtained from children on the autism spectrum. After the test, autism spectrum subjects will be randomly divided into intervention and control groups. Finally, the training intervention session will refer to the members of the intervention group.
Main outcome variables
speech and language skills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220311054258N1
Registration date:2022-05-29, 1401/03/08
Registration timing:retrospective
Last update:2022-05-29, 1401/03/08
Update count:0
Registration date
2022-05-29, 1401/03/08
Registrant information
Name
mahsa mehdizadeh behtash
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3320 4202
Email address
mahsamehdizadeh.slp@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-12, 1400/12/21
Expected recruitment end date
2022-03-15, 1400/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of signing education on speech and language skills of patients with autism spectrum disorders: A clinical trial
Public title
The effect of signing education on speech and language skills of patients with autism spectrum disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of autism spectrum disorders by a neurologist
Confirmation of the diagnosis of autism spectrum disorders by the screening form of children with autism spectrum disorder
Absence of other psychological and psychiatric disorders except autism
Living with both parents
Level of education of parents at least a diploma
The place of residence is the city of Tabriz
The subject belongs to the autism spectrum disorders with low performance and non-verbal.
Age of entry at least 3 to a maximum of 10 years
Exclusion criteria:
Receive other parallel rehabilitation and training interventions during the intervention
Absence of one of the conditions of inclusion criteria
Absence of more than one session
Existence of speech or number of words more than three or four words
Suffering from sensory defects
Having motor defects
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Each participant was assigned a code
Using a simple random allocation strategy and using a random number table method, eligible participants were divided into intervention or control groups.
In this random method, a table without a specific pattern or order is used. With the help of a table of random numbers, one digit is assigned to each person. Numbers with even numbers are assigned to the control group and odd numbers to the actual intervention group.
Participants did not know the true purpose of the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were randomized by the research team in their absence and none of them was aware of the intervention group they were in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz / 29 Bahman Blvd. / University of Tabriz / Next to Vahdat Hall, Faculty of Rehabilitation Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5157658134
Approval date
2022-03-01, 1400/12/10
Ethics committee reference number
IR.TBZMED.REC.1400.1191
Health conditions studied
1
Description of health condition studied
Autism spectrum
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Speech and language skills changes in children with autism spectrum after receiving sign education
Timepoint
Newsha test and the verbal imitation will be calculated at the beginning of the study and finally, after the intervention, the language skills test will be performed again.
Method of measurement
Nyusha Hearing, Language, and Speech Development Test: Subtests related to spoken, received, and spoken language of this test will be used and the results will be recorded in special forms. Verbal imitation test: A test used by Dr. Rafiei in his master's thesis is used for this purpose.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: only for this group, reference therapies will be used. In this study, 7 objects (mirror, comb, automatic, house, spoon, umbrella and glass) up to 7 verb images (driving, sleeping, smelling) , Reading, calling, licking and cuddling) are selected. 7 objects and pictures are taught for three months and three half-hour sessions per week. And then, without the examiner's knowledge of their group, they are examined by the Newsha test.
Category
Rehabilitation
2
Description
Control group: No special intervention will be performed for the control group and only the usual and traditional therapies available for speech therapy will be used.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Atieh Under-15 Training and Rehabilitation Center
Full name of responsible person
Zahra Nik Nafs Bagheri
Street address
Imam Street, Bafghi Wild Street
City
ilkhichi
Province
East Azarbaijan
Postal code
5157658134
Phone
+98 41 3341 7458
Email
Mta1386@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Tabriz / Azadi St. / Golgasht St. / Central Building of University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5157658134
Phone
+98 41 3335 5921
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Jafar Masumi Komanj
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Tabriz / 29 Bahman Blvd. / University of Tabriz / Next to Vahdat Hall, Faculty of Rehabilitation Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5157658134
Phone
+98 41 3337 2072
Email
masumij@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Jafar Masumi Momanj
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Tabriz / 29 Bahman Blvd. / University of Tabriz / Next to Vahdat Hall, Faculty of Rehabilitation Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5157658134
Phone
+98 41 3337 2072
Email
masumij@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahsa Mehdizadeh behtash
Position
Master of speech therapy- faculty of rehabilitation
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Valiasr/ negin park street/ shaqayeq alley/ no22 5th floor
City
Tabriz
Province
East Azarbaijan
Postal code
5157658134
Phone
+98 41 3320 4202
Fax
Email
mahsamehdizadeh.slp@gmail.com
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
Due to the lack of permission of the moral code
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available