Evaluation Effect of PRT Training to mothers on Improving the Communication Skills of Nonverbal Autism Spectrum Disorder Children
Design
Clinical trials, Has a control group, community based and pragmatic, double blind, randomized, with 52 patients
Settings and conduct
Autism centers of Khuzestan province, after sampling, individuals are randomly assigned into intervention and control groups. Speech/language and communication scores and socialization of children The autism spectrum was measured before intervention, one week after the intervention and one month after the intervention. Also, at the beginning of the study, the demographic data of the child, mother and family will be gathered by the mother asking questions
Participants/Inclusion and exclusion criteria
include: 1-age of the child Autistic Spectrometer 3-6 years 2-child Autism Spells 3-The absence of other associated disorders such as Down Syndrome And physical disabilities such as cerebral palsy 4- mother's Literacy at least Primary school 5-Mother language is Persian 6-Satisfaction of individuals to participate in the study 7-Children with autism with maximum standard deviation of speech/communication language 3± and a maximum standard deviation of 10±
Exclude:No regular mothers' participation in training sessions
Intervention groups
Responsive interventional method is designed to enhance the verbal responsiveness of parents to children who are being taught to improve their child's ability to communicate with the etitism spectrum
Main outcome variables
Speech/Language and Communication Scores The autism spectrum (based on the ATEC test) in the case and control group before and after the intervention is different from the pre-interventional one.
The child's socialization rate of the autistic spectrum (based on the ATEC test) after the intervention, case and control in the case group is different from the control group.
General information
Reason for update
Acronym
PRT
IRCT registration information
IRCT registration number:IRCT20180518039703N1
Registration date:2018-07-04, 1397/04/13
Registration timing:registered_while_recruiting
Last update:2018-07-04, 1397/04/13
Update count:0
Registration date
2018-07-04, 1397/04/13
Registrant information
Name
Farzaneh Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4228 5268
Email address
abdi.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-01, 1397/04/10
Expected recruitment end date
2018-10-02, 1397/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Effect of PRT Training to mothers on Improving the Communication Skills of Nonverbal Autism Spectrum Disorder Children
Public title
An Investigation effect of Responsive Intervention Method on Improving Speech and Communication in Children Autism
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The child has no austerity
The absence of other abnormalities (Except for the autism spectrum), such as Down syndrome and physical disorders, including cerebral palsy
At least the mother's literacy is a primary school and the mother language is Persian and also the satisfaction of people to participate in the study.
Children with autism with a maximum standard deviation of speech / communication language 3 ± and a maximum standard deviation of 10 ±
Exclusion criteria:
The lack of regular mothers' participation in training sessions
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly assigned to two groups of intervention and control (with the help of a random number table)
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the participants and the researcher will be unaware of their professional skills
Placebo
Not used
Assignment
Parallel
Other design features
This method is very effective, and contrary to the previous educational methods in which the child was forced to obey the teacher according to the previous plan.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2018-02-02, 1396/11/13
Ethics committee reference number
IR.AJUMS.REC.1396.1113
Health conditions studied
1
Description of health condition studied
Children have no autistic spectrum
ICD-10 code
Schizophre
ICD-10 code description
Chapter VMental and behavioural disorders(F00-F99)
Primary outcomes
1
Description
Speech / Language score and child autism spectrum communication
Timepoint
12 sessions per week will be followed by a one-and-a-half hour session, and 12 sessions of routine therapy (including Applied Behavioral Analysis treatment) will be provided for these children. Control group children receive routine treatment at the center for 24 sessions
Method of measurement
Autism Spectrum Evaluation Checklist (ATEC)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For 12 sessions a week, one session will be followed by one and a half hours. Also, 12 sessions of routine treatment (including Applied Behavioral Analysis treatment) will be provided for these children.
Category
Behavior
2
Description
A routine treatment (including ABA treatment) is given for 24 sessions
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Farzaneh Rehabilitation Center for Autistic Spectrum Disorders
Full name of responsible person
Farzaneh Abdi
Street address
between Aristotle and Qarani Streets, Wafa Street, Dezful.
City
Dezful
Province
Khouzestan
Postal code
6461894186
Phone
+98 61 4252 5729
Email
farzaneabdi.slp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badawi
Street address
Ground floor, Jundishapur University of Medical Sciences and Health Services, Assistant Professor of Research and Technology, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hosseyn Rezaaii
Position
teacher
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311
Email
Hosseynrezaaii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hosseyn Rezaaii
Position
teacher
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan St, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311
Email
Hosseynrezaaii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farzaneh Abdi
Position
Master of Sciences Student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
No. 184, Golestan 8, Shariati Blvd, Dezful.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311
Email
Farzaneabdi.slp@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available