Protocol summary
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Study aim
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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
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Design
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A clinical trial with a controlled group with parallel groups, double-blind, randomized
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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verbal initiation; absolute and relative power of brain's waves, coherence
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2019-04-23, 1398/02/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-06-22, 1397/04/01
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Expected recruitment end date
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2020-03-20, 1399/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The Effect of Pivotal Response Treatment on children with Autism Spectrum Disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 6 years old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
20
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-19, 1397/09/28
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Ethics committee reference number
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IR.TUMS.FNM.REC.1397.173
Health conditions studied
1
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Description of health condition studied
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Autism
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ICD-10 code
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F84.0
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ICD-10 code description
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Autistic disorder
Primary outcomes
1
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Description
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Verbal initiation ability
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Timepoint
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Befor and after treatment
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Method of measurement
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Parents report and parent's interaction with her child
Secondary outcomes
1
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Description
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Power spectral density
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Timepoint
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Before and after treatment
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Method of measurement
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Quantitative Electroencephalography
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The results of the original outcome are published.
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When the data will become available and for how long
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Start the access period 6 months after printing the results
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To whom data/document is available
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Researchers working in scientific and academic institutions and those working in the field of autism
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Under which criteria data/document could be used
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To research and use in the treatment of children with autism
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From where data/document is obtainable
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E-mail with Dr. Zahra Soleymani and Fereshteh Mohammadzaheri.
f-mzaheri@razi.tums.ac.ir
soleymaniz@tums.ac.ir
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What processes are involved for a request to access data/document
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Once the email is viewed, it will be sent within a week.
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Comments
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