There are great challenges in the treatment of autism. In order to assess the efficacy of intercessory prayer on symptoms improvement in autistic children, we designed a randomized clinical trial (RCT) in 30 children with autism described in DSM-4 and ICD-10. The study population will be randomized into intervention and control groups. Both groups will receive the routine therapies. The intervention group will also receive the intervention including two months of intercessory prayer by 5 physicians. Standardized measures including: 1.Gilliam Autism Rating Scales (GARS) Questionnaire 2.Autism Treatment Evaluation Checklist 3.autims social skills profile 4. Parental stress index questionnaire; will be used to assess the efficacy of intercessory prayer treatment on improvement of the autism symptoms, as well as the parental stress level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808202698N1
Registration date:2010-10-10, 1389/07/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-10, 1389/07/18
Registrant information
Name
Batool Mousavi
Name of organization / entity
Janbazan Medical and Engeenering Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2399 2287
Email address
bmousavi@jmerc.ac.ir
Recruitment status
Recruitment complete
Funding source
Family Research Institute
Expected recruitment start date
2010-08-11, 1389/05/20
Expected recruitment end date
2011-08-26, 1390/06/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of efficacy of intercessory prayer on symptoms of children with autism and parental stress
Public title
Efficacy of intercessory prayer on severity of symptoms of children with autism and parental stress
Purpose
Treatment
Inclusion/Exclusion criteria
Definitive Diagnosis of Autism based on DSM- 4
Age
From 3 years old to 9 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Family Research Institude
Street address
Shahid Beheshti University
City
Tehran
Postal code
Approval date
2010-06-13, 1389/03/23
Ethics committee reference number
62/850/ص
Health conditions studied
1
Description of health condition studied
Childhood Autism
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
verbal skills
Timepoint
2 weeks before the study, at the beginning of the study and once per month while intervention is underway, and one month after the last intervention
Method of measurement
Gilliam Autism Rating Scale-GARS- Questionnaire by the trainers and Autism Treatment and Evaluation Checklist by the parent
2
Description
social skills
Timepoint
2 weeks before the study, at the beginning of the study and once per month while intervention is underway, and one month after the last intervention
Method of measurement
Gilliam Autism Rating Scale-GARS- Questionnaire by trainers and Autism Treatment Evaluation Checklist and autims social skills profile by parent
3
Description
sterotyped behavior
Timepoint
2 weeks before the study, at the beginning of the study and once per month while intervention is underway, and one month after the last intervention
Method of measurement
Autism Treatment Checklist by Parent, Gilliam Autism Rating Scale-GARS- by Trainers
4
Description
cognitive and sensory awareness
Timepoint
2 weeks before the study, at the beginning of the study and once per month while intervention is underway, and one month after the last intervention
Method of measurement
Autism treatment evaluation checklist by the parent
Secondary outcomes
1
Description
parental stress
Timepoint
2 weeks before the study, at the beginning of the study and once per month while intervention is underway, and one month after the last intervention
Method of measurement
parental stress index questionnaire by the parents
Intervention groups
1
Description
Intervention group: They will receive both their routine treatment and intercessory prayer for 8 weeks- 3 times per week for 10 minutes. 5 phisicians will accomplish the intervention
Category
Treatment - Other
2
Description
Control group: The group will receive their routine treatment but not the intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for the treatment of autistic disorders
Full name of responsible person
Dr Hamid Reza Pouretemad
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Family Research Institude
Full name of responsible person
Dr Hamid Reza Pouretemad
Street address
Shahid Beheshti University
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Family Research Institude
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
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Karbakhsh
Position
Assistant Professor in Community Medicine
Other areas of specialty/work
Street address
Department of Community Medicine, PoorSina St, Qods St, Enqelab St
City
Tehran
Postal code
Phone
+98 21 8896 2357
Fax
+98 21 8896 2357
Email
mkarbakh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dept. of psychology, Shahid Beheshti University/ The center for the treatment of autistic disorder
Full name of responsible person
Hamid Reza Pouretemad
Position
PhD
Other areas of specialty/work
Street address
Dept. of psychology, Shahid Beheshti University. Evin
City
Tehran
Postal code
Phone
+98 21 8801 0162
Fax
Email
h-pouretemad@sbu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Janbazan Medical and Engeenering Research Center
Full name of responsible person
Batool Mousavi
Position
Head of prevention department
Other areas of specialty/work
Street address
No 16, Farid Afshar, Zafar
City
Tehran
Postal code
Phone
+98 21 2399 2287
Fax
Email
mousavi.b@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)