The Effect of Pivotal Response Treatment on the Verbal Initiations Among 6-12 years old children with Autism Spectrum Disorder Using Behavioral and Electrophysiologic Analyses
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Protocol summary
32 Autistic children in Arak are randomly assigned to one of the two groups without a mother's notice. Before and after the start of the study, verbal initiations are checked, and from each child is recorded quantitative electroencephalography. The treatment group receives 5 sessions of pivotal response treatment each week and the control group continues to their former treatment. At the end of treatment, verbal initiation and electroencephalographic data are analyzed without assessment' notice of the type of treatment for each child.
20Autistic children in Arak are randomly assigned to one of the two groups without a mother's notice. Before and after the start of the study, verbal initiations are checked, and from each child is recorded electroencephalography. The treatment group receives 5 sessions of pivotal response treatment each week and the control group continues to their former treatment. At the end of treatment, verbal initiation and electroencephalographic data are analyzed without assessment' notice of the type of treatment for each child.
32 Autistic20Autistic children in Arak are randomly assigned to one of the two groups without a mother's notice. Before and after the start of the study, verbal initiations are checked, and from each child is recorded quantitative electroencephalography. The treatment group receives 5 sessions of pivotal response treatment each week and the control group continues to their former treatment. At the end of treatment, verbal initiation and electroencephalographic data are analyzed without assessment' notice of the type of treatment for each child.
32 کودک مبتلا به اوتیسم شهر اراک به طور تصادفی بدون اطلاع مادر در یکی از دو گروه مداخله قرار می گیرند. قبل و بعد از شروع مطالعه آغازگری های کلامی کودک بررسی می گردد و از هر کودک الکتروانسفالوگرافی کمی ثبت می گردد. گروه درمانی هفته ای 5 جلسه درمان پاسخ محور دریافت می کند و گروه کنترل به درمان قبلی خود ادامه می دهد.در پایان درمان تعداد آغازگری های کلامی و داده های الکترو انسفالوگرافی بدون اطلاع ارزیاب از نوع درمان هر کودک انالیز می گردد.
۲۰کودک مبتلا به اوتیسم شهر اراک به طور تصادفی بدون اطلاع مادر در یکی از دو گروه مداخله قرار می گیرند. قبل و بعد از شروع مطالعه آغازگری های کلامی کودک بررسی می گردد و از هر کودک الکتروانسفالوگرافی کمی ثبت می گردد. گروه درمانی هفته ای 5 جلسه درمان پاسخ محور دریافت می کند و گروه کنترل به درمان قبلی خود ادامه می دهد.در پایان درمان تعداد آغازگری های کلامی و داده های الکترو انسفالوگرافی بدون اطلاع ارزیاب از نوع درمان هر کودک انالیز می گردد.
32 ۲۰کودک مبتلا به اوتیسم شهر اراک به طور تصادفی بدون اطلاع مادر در یکی از دو گروه مداخله قرار می گیرند. قبل و بعد از شروع مطالعه آغازگری های کلامی کودک بررسی می گردد و از هر کودک الکتروانسفالوگرافی کمی ثبت می گردد. گروه درمانی هفته ای 5 جلسه درمان پاسخ محور دریافت می کند و گروه کنترل به درمان قبلی خود ادامه می دهد.در پایان درمان تعداد آغازگری های کلامی و داده های الکترو انسفالوگرافی بدون اطلاع ارزیاب از نوع درمان هر کودک انالیز می گردد.
General information
Simple randomization: According to inclusion and exclusion criteria, 32 children are selected and each of them is assigned a number from 1 to 32. then, The numbers are placed in a bag and drawn into lottery and alternating placed in the intervention and control group.
Simple randomization: According to inclusion and exclusion criteria, 20children are selected and each of them is assigned a number from 1 to 20. then, The numbers are placed in a bag and drawn into lottery and alternating placed in the intervention and control group.
Simple randomization: According to inclusion and exclusion criteria, 32 children20children are selected and each of them is assigned a number from 1 to 3220. then, The numbers are placed in a bag and drawn into lottery and alternating placed in the intervention and control group.
تصادفی سازی ساده: طبق معیارهای ورود و خروج 32کودک انتخاب شده و به هریک از آنها شماره ای از 1 تا 32 اختصاص داده می شود. سپس شماره ها در کیسه ای قرار داده شده و قرعه کشی به عمل می آید و به طور یک در میان در گروه مداخله و کنترل قرار می گیرند.
تصادفی سازی ساده: طبق معیارهای ورود و خروج ۲۰کودک انتخاب شده و به هریک از آنها شماره ای از 1 تا ۲۰ اختصاص داده می شود. سپس شماره ها در کیسه ای قرار داده شده و قرعه کشی به عمل می آید و به طور یک در میان در گروه مداخله و کنترل قرار می گیرند.
تصادفی سازی ساده: طبق معیارهای ورود و خروج 32کودک۲۰کودک انتخاب شده و به هریک از آنها شماره ای از 1 تا 32۲۰ اختصاص داده می شود. سپس شماره ها در کیسه ای قرار داده شده و قرعه کشی به عمل می آید و به طور یک در میان در گروه مداخله و کنترل قرار می گیرند.
Protocol summary
Study aim
Determination of the effect of pivotal response treatment on verbal initiation in 6 to 12 years old children with autism spectrum disorders using behavioral and electrophysiological analyzes
Design
A clinical trial with a controlled group with parallel groups, double-blind, randomized
Settings and conduct
20Autistic children in Arak are randomly assigned to one of the two groups without a mother's notice. Before and after the start of the study, verbal initiations are checked, and from each child is recorded electroencephalography. The treatment group receives 5 sessions of pivotal response treatment each week and the control group continues to their former treatment. At the end of treatment, verbal initiation and electroencephalographic data are analyzed without assessment' notice of the type of treatment for each child.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age(6-12 years old), autism spectrum disorder, Mean Length of Utterance of two words, No spontaneous questions, right handed
Exclusion criteria: Missing more than 3 sessions, Disconnecting the child, Parental disagreement
Intervention groups
Intervention group( intervention with pivotal response treatment): The PRT intervention is based on the published manual: Teaching the Pivotal Behavior of Initiations to Children with Autism (Koegel 2011). PRT sessions will be conducted three times a week for two months, for a total of 24 one-hour sessions. Parents will be required to participate in the sessions at least twice a week for the entire two months of the study.
Control group: the children of this group continue their usual treatment and will not receive any PRT. Parents will be required to participate in the sessions at least twice a week for the entire two months of the study.
Main outcome variables
verbal initiation; absolute and relative power of brain's waves, coherence
General information
Reason for update
Due to the spread of the covid-19 pandemic and the closure of rehabilitation centers and the lack of families cooperation to participate in the research, the issue was discussed with the supervisor and the statistics consultant, and according to the letter sent from the Ministry of health affairs to the universities to reduce the sample size during the Corona period, and Significant results were obtained with the number of 10 samples in each group (total of 20 samples). The study was conducted with 20 samples.
Acronym
IRCT registration information
IRCT registration number:IRCT20180617040124N1
Registration date:2019-04-23, 1398/02/03
Registration timing:registered_while_recruiting
Last update:2023-01-30, 1401/11/10
Update count:2
Registration date
2019-04-23, 1398/02/03
Registrant information
Name
Fereshteh Mohammadzaheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1529
Email address
F-MZAHERI@RAZI.TUMS.AC.IR
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Pivotal Response Treatment on the Verbal Initiations Among 6-12 years old children with Autism Spectrum Disorder Using Behavioral and Electrophysiologic Analyses
Public title
The Effect of Pivotal Response Treatment on children with Autism Spectrum Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 6;0 to12 years old at the start of the study
Diagnosis of autism spectrum disorder: Participants must have a diagnosis of an autism spectrum disorder as assessed by a child psychiatrist or clinical psychologist according to DSM-V criteria before their baseline assessment. This judgment will be supported by the results of gold-standard diagnostic instruments—the GARS(Gilliam Autism Rating Scale)—administered by two speech pathologist
high function autistic children: to earn score 30-36 in CARS
Mean Length of Utterance( MLU) of at least two words
No spontaneous questions in the speech
no receive verbal initiation training while entering the study
no receive other behavioral treatments during treatment in the intervention group
All participants must be right handed
parents must agree to participate in the intervention sessions
the loss of other Health impairment such as visual or hearing impairments
the loss of epilepsy or brain injury
the loss of other psychiatric Disorders ((e.g., schizophrenia, ADHD)
the loss of spike wave in EEG
Do not take medication or take similar medications
Exclusion criteria:
Parental dissatisfaction or disagreement to continue attending treatment sessions
Disconnecting the child in the study
Missing more than 3 sessions of treatment sessions
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: According to inclusion and exclusion criteria, 20children are selected and each of them is assigned a number from 1 to 20. then, The numbers are placed in a bag and drawn into lottery and alternating placed in the intervention and control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants are not given information on which treatment group they are located. Also, the person who analyzes the data is unaware of the allocation of people in the type of group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
South Worker, Enghelab Ave, Rehabilitation College
City
Tehran
Province
Tehran
Postal code
1148965141
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.TUMS.FNM.REC.1397.173
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Verbal initiation ability
Timepoint
Befor and after treatment
Method of measurement
Parents report and parent's interaction with her child
Secondary outcomes
1
Description
Power spectral density
Timepoint
Before and after treatment
Method of measurement
Quantitative Electroencephalography
Intervention groups
1
Description
Intervention group( intervention with pivotal response treatment): The PRT intervention is based on the published manual: Teaching the Pivotal Behavior of Initiations to Children with Autism (Koegel 2011). This manual focuses on verbal initiations, mostly in the form of questions. In this intervention, items will be selected according to the child’s preference for question-asking sessions. PRT sessions will be conducted in a one-on-one setting three times a week for two months, for a total of 24 one-hour sessions. Parents will be required to participate in the sessions at least twice a week for the entire two months of the study. and ask them to practice with their children three times a day.
Category
Rehabilitation
2
Description
Control group: the children of this group continue their usual treatment and will not receive any PRT. Parents will be required to participate in the sessions at least twice a week for the entire two months of the study. The parents must be willing work with their children three times a day.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Baran occupational therapy center
Full name of responsible person
Zahra soleymani
Street address
Ostadan Ave., Qods Blvd., Madar Town
City
Arak
Province
Markazi
Postal code
3818144679
Phone
+98 86 3366 6363
Email
fereshteh.mz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Rezaei
Street address
ghods Ave., Keshavarz Blvd.,Tehran University of Medical Sciense
City
Tehran
Province
Tehran
Postal code
1148965141
Phone
+98 21 8163 3698
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Soleymani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Sout Worker., Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Email
soleymaniz@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Soleymani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Southern worker., Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Email
soleymaniz@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fereshteh Mohammadzaheri
Position
phd student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Sout Worker., Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Email
f-mzaheri@razi.tums.ac.ir
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
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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the original outcome are published.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in scientific and academic institutions and those working in the field of autism
Under which criteria data/document could be used
To research and use in the treatment of children with autism
From where data/document is obtainable
E-mail with Dr. Zahra Soleymani and Fereshteh Mohammadzaheri.
f-mzaheri@razi.tums.ac.ir
soleymaniz@tums.ac.ir
What processes are involved for a request to access data/document
Once the email is viewed, it will be sent within a week.