Protocol summary

Summary
The present study is a two groups and two phases clinical trial that aimed to investigate the effect of mobile parenting skills education on anxiety of the mothers and symptoms of autistic children. Main inclusion criteria were the ability to read text messages; having a mobile with Farsi short message service, lack of acute and chronic physical and mental disease during the study period and main exclusion criteria was exposure of the mothers to severe stressor during the study in both groups.Sixty four mothers of the children suffering from autism who had a medical file,recruited by convenient sampling, in Isfahan selected autism centers. Then, the subjects were randomly assigned into two 32 subject groups of study and control. Book of “Parenting skills for the mothers with autistic children” was distributed in study and control groups, and then, study group underwent a structured mobile text messages education. Sixty daily text messages were sent to the subjects in study group for two months. Subjects in both groups answered to Spielberger Anxiety questionnaire for themselves and Garz-2 questionnaire for their children before and one week after completion of the intervention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015080223454N1
Registration date: 2015-10-15, 1394/07/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-15, 1394/07/23
Registrant information
Name
Zahra Haji abolhasani Nargani
Name of organization / entity
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7514
Email address
z_abolhasani@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-04-14, 1394/01/25
Expected recruitment end date
2015-06-19, 1394/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of mobile parenting skills education on anxiety of the mothers and symptoms of autistic children
Public title
Effect of mobile Autism parenting skills education
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The ability to read text messages; having motivation to participate and the ability to cooperate in the study; having a mobile with Farsi short message service; lack of acute and chronic physical and mental disease during the study period and not to participate in similar research simultaneously Exclusion criteria: Failure to cooperate with the investigation in any phase and for any reason and exposure of the mothers to severe stressors during the study in both groups
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
A sample of 64 subjects were randomly recruited considering sampling framework and then they were randomly allocated by a table of random numbers to the intervention and control groups (N=32 in each group).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jrib Avenue, Isfahan
City
Isfahan
Postal code
Approval date
2015-02-18, 1393/11/29
Ethics committee reference number
393863

Health conditions studied

1

Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Childhood Autism

Primary outcomes

1

Description
anxiety
Timepoint
before the intervention, a week after completion of the intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory (STAI) Questionnaire

2

Description
Added at 2015-11-10: symptoms of autism
Timepoint
Added at 2015-11-10: before the intervention, a week after completion of the intervention
Method of measurement
Added at 2015-11-10: Gilliam Autism Rating Scale Second-edition (GARS-2)Questionnaire

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
intervention group: Book of “Parenting skills for the mothers with autistic children” was distributed in intervention group, and then, they underwent a structured mobile text messages education. In this regard, sixty daily text messages were sent to the subjects in study group for two months.
Category
Placebo

2

Description
control group: For the control group, only Book of “Parenting skills for the mothers with autistic children” was distributed among them.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Zahra charity for autistic patients in Isfahan
Full name of responsible person
Dr. Mostafa Najafi
Street address
End Alley Martyr Javanmardi, Alley 17, Beside Culture House of FADAK, Eastern Sheikh Mofid Street, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Mahdi Nematbakhsh
Street address
Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
City
Isfahan
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 of Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
Full name of responsible person
Tayebeh Mehrabi
Position
Msc of Nursing, Department of Nursing Psychiatry,Member of Faculty of Nursing and Midwifery, Isfahan
Other areas of specialty/work
Street address
Hezar jerib Avenue, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 7595
Fax
Email
mehrabi@nm.mui.ac.ir
Web page address
www.nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences,Faculty of Nursing and Midwifery
Full name of responsible person
Zahra Haji abolhasani Nargani
Position
Msc Student of Nursing
Other areas of specialty/work
Street address
Hezar jerib Avenue, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3743 4965
Fax
Email
z_abolhasani@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
Full name of responsible person
Zahra Haji abolhasani Nargani
Position
Msc Student of Nursing
Other areas of specialty/work
Street address
No. 21, Reshadat Alley, Chehel dastgah, Imam Khomeini Street, Falavarjan, Isfahan
City
Falavarjan
Postal code
8451844471
Phone
+98 31 3743 4965
Fax
Email
z_abolhasani@nm.mui.ac.ir; zhajiszf@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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