Objectives: The aim of this research is assessing effectiveness of Pivotal Response Treatment in decreasing behavioral and communicative problems in autistic boys between 8-12 years old.
Design: This is a randomized clinical trial (RCT) with pre- and post test assessment.
Setting and Conduct: One group will receive the PRT therapies and other group no treatment. ADI-R test, which is a standard measure, will be used as pre- and post-test to assess the efficacy of PRT.
Participants: We design a in 24 children with autism described in DSM-4. The study population will be randomized into intervention and control groups.
Intervention: The intervention group receive PRT during 10 weeks, while the control group will not be under this treatment as their previous year.
Main outcome measurement variables: We expect to see increasing the socialization abilities in the intervention group after PRT.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205259854N1
Registration date:2012-10-10, 1391/07/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-10, 1391/07/19
Registrant information
Name
Mojtaba Soltanlou
Name of organization / entity
University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 21 6623 6219
Email address
soltanlou@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Beautiful Mind Rehabilitation Clinic
Expected recruitment start date
2012-06-07, 1391/03/18
Expected recruitment end date
2012-09-08, 1391/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Pivotal Response Treatment in decreasing behavioral and communicative problems in autistic boys between 8-12 years old
Public title
Pivotal Response Treatment (PRT) in Autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: 8-12 years old; diagnosis of Autism by Psychiatrist based on DSM IV; no other treatment;
Exclusion: Other neurological disorder such as cerebral palsy; seizure; metabolic disorder; change in drugs during the intervention;
Age
From 8 years old to 12 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Tonekabon
Street address
Educational complexity of Islamic Azad University of Tonekabon, Vali Abad
City
Tonekabon
Postal code
Approval date
2012-08-23, 1391/06/02
Ethics committee reference number
15920701882006
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
Socialization
Timepoint
Pre- intervention and 10 weeks after intervention
Method of measurement
ADI- R Questionnaire
Secondary outcomes
1
Description
Declining communication problems and stereotype behaviors
Timepoint
Pre- intervention and 10 weeks after intervention
Method of measurement
ADI- R Questionnaire
Intervention groups
1
Description
Pivotal Response Treatment in intervention group will be done for 20 sessions during 10 weeks. PRT is a behavioral treatment which therapist will select the intervention based on client's response and is completely client center.
Category
Rehabilitation
2
Description
Control group include autistic children who are not under any treatment and also will not receive any other during the research period.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Peyke Honar Autism School
Full name of responsible person
Elham Vadi
Street address
West 44 Alley, Kalantari Sq., Yousef Abad
City
Tehran
2
Recruitment center
Name of recruitment center
Beautiful Mind Rehabilitation Clinic
Full name of responsible person
Mojtaba Soltanlou
Street address
No. 3, 16th Alley, Parvaneh St., Nasr bridge
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University - Tonekabon Branch
Full name of responsible person
Dr Khalil Pour Shamsian
Street address
Educational complexity of Islamic Azad University of Tonekabon, Vali Abad
City
Tonekabon
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Islamic Azad University - Tonekabon Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Mojtaba Soltanlou
Position
PhD Student of Cognitive Neuroscience
Other areas of specialty/work
Street address
Emam Khomeini St., 29 Bahman Blvd.
City
Tabriz
Postal code
5166616471
Phone
+98 21 6623 6219
Fax
+98 21 8863 9921
Email
soltanlou@razi.tums.ac.ir
Web page address
http://www.tabrizu.ac.ir/fa/index.htm
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Mojtaba Soltanlou
Position
PhD Student of Cognitive Neuroscience
Other areas of specialty/work
Street address
Emam Khomeini St., 29 Bahman Blvd.
City
Tabriz
Postal code
5166616471
Phone
+98 21 6623 6219
Fax
+98 21 8863 9921
Email
soltanlou@razi.tums.ac.ir
Web page address
http://www.tabrizu.ac.ir/fa/index.htm
Person responsible for updating data
Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Mojtaba Soltanlou
Position
PhD Student of Cognitive Neuroscience
Other areas of specialty/work
Street address
Emam Khomeini St., 29 Bahman Blvd.
City
Tabriz
Postal code
5166616471
Phone
+98 21 6623 6219
Fax
+98 21 8863 9921
Email
soltanlou@razi.tums.ac.ir
Web page address
http://www.tabrizu.ac.ir/fa/index.htm
Sharing plan
Deidentified Individual Participant Data Set (IPD)