Protocol summary

Study aim
Determination of the effect of educational intervention based on Social cognitive theory on Quality of life among parents of Autistic patients in Tehran Autism Centers
Design
Randomized control trial with control group, with parallel group, not blinded and randomized, sample size 74, pretest post test and follow up,1and 6 month follow up
Settings and conduct
This study was performed among the parents of autistic students of autism schools in Tehran. Thus, in the intervention group, self-care education was designed based on cognitive-social theory and implemented through telegram for three months. The control group did not receive any training. Data from both groups before, one month and 6 months after the intervention were collected using SF36 questionnaire and CarerQol questionnaire and analyzed by SPSS20 software.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Parents of autistic students under 13 years old in autism schools of Tehran Exceptional Education Organization.Having a smart phone and access to the Telegram application and the ability to use it and Willingness to participate in the study.
Intervention groups
The intervention group included the parents of autistic students of autism schools in Tehran, who received an educational intervention designed based on social cognitive theory via telegram. The control group included the parents of autistic students of autism schools in Tehran who did not receive educational intervention.
Main outcome variables
Quality of life among parents of Autistic patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200922048797N1
Registration date: 2020-12-11, 1399/09/21
Registration timing: registered_while_recruiting

Last update: 2020-12-11, 1399/09/21
Update count: 0
Registration date
2020-12-11, 1399/09/21
Registrant information
Name
Samaneh Abolkheirian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3318 0272
Email address
sabolkherian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-14, 1398/09/23
Expected recruitment end date
2020-12-13, 1399/09/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and Evaluation of Theory based Intervention on Quality of life among parents of Autistic patients
Public title
The effect of educational intervention based on Social Cognitive Theory on Quality of Life among parents of Autistic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Parents of autistic students under 13 years old in autism schools of Tehran Exceptional Education Organization Having a smart phone and access to the Telegram application and the ability to use it Willingness to participate in the study
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, after preparing the list of autism centers of exceptional education in Tehran, first the names of all centers were written on balls and put in a bag. Then 6 centers were randomly selected. Among the above centers, three centers were randomly placed in the intervention group and three centers as the control group using the random draw method. In fact, the randomization unit in this study was clusters..
Blinding (investigator's opinion)
Not blinded
Blinding description
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
School of health, Tehran University of Medical science, Pour Sina Ave,Keshavarz Blvd,
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2017-12-02, 1396/09/11
Ethics committee reference number
IR.TUMS.SPH.REC.1396.4130

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
Quality of life Score in the Questionnaire
Timepoint
In this study, the quality of life of parents was measured before intervention and one month and six months after the intervention.
Method of measurement
SF36 questionnaire and CarerQol questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
the intervention group: In the intervention group, self-care training based on social cognitive theory was conducted using the Telegram group for three months. These tutorials included text messages, pictures, and short instructional videos, as well as podcasts that were sent to parents via the Telegram software.
Category
Behavior

2

Description
Control group: Control group: No action was taken in the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Autism Schools in Tehran
Full name of responsible person
Samaneh Abolkheirian
Street address
school of health, Pour Sina Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3210
Email
samanehabolkherian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3698
Email
msahrai@sina.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
Samaneh Abolkheirian
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
school of health, Pour Sina Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
141761351
Phone
+98 21 4293 3210
Email
samanehabolkherian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samaneh Abolkheirian
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
school of health, Pour Sina Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3210
Email
samanehabolkherian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samaneh Abolkheirian
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
school of health, Pour Sina Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 3210
Email
samanehabolkherian@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people.
When the data will become available and for how long
Start the access period, 6 months after publishing the results
To whom data/document is available
Data will only be available to researchers in academia.
Under which criteria data/document could be used
It is permitted to use data for all scientific works within the framework of ethics in research.
From where data/document is obtainable
To receive the data, the official request of the applicant (via organizational email) should be sent to Samaneh Abolkheirian email and only through the address: samanehabolkherian@yahoo.com.
What processes are involved for a request to access data/document
The applicant application (via organizational email) should be sent to samanehabolkherian@yahoo.com and after confirmation, the data will be provided to the applicant within 14 days.
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