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IRCT20180617040124N1 IRCT 2019-04-23 Tehran University of Medical Sciences The Effect of Pivotal Response Treatment on children with Autism Spectrum Disorder 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 2018-06-22 anticipated 20 Complete https://irct.ir/trial/36343 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Autism. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The effect of treatment is investigated in a group. Therefore, individual data is not published.
public Zahra Soleymani
Sout Worker., Enghelab Ave
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 5132 soleymaniz@tums.ac.ir Tehran University of Medical Sciences scientific Zahra Soleymani
Southern worker., Enghelab Ave
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 5132 soleymaniz@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 6 years 12 years Both Parental dissatisfaction or disagreement to continue attending treatment sessions Disconnecting the child in the study Missing more than 3 sessions of treatment sessions F84.0 Autistic disorder Rehabilitation Rehabilitation 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. 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. Verbal initiation ability. Timepoint: Befor and after treatment. Method of measurement: Parents report and parent's interaction with her child. Power spectral density. Timepoint: Before and after treatment. Method of measurement: Quantitative Electroencephalography. Tehran University of Medical Sciences Approved 2018-12-19 Ethics committee of Tehran University of Medical Science South Worker, Enghelab Ave, Rehabilitation College Tehran Tehran Iran (Islamic Republic of)