Protocol summary

Summary
The purpose of this study was to investigate the effect of parental involvement in teaching the child's safe street-crossing behavior. Entry requirement: First grade elementary school boys whose informed consent form was signed by their parents. Children who did not attend at least one of the eight educational sessions were excluded from the study. Method: 149 students with an average age of 7.5 years from the three elementary schools in six classes were present. Studied schools were selected haphazardly and each one randomly assigned to the test group, active control and control group. In the group, test group, instilling a child at school continued with pieces of homework with the help of parents at home. The second group or active control group was also given the same instruction at school but with no homework. The third group played the role of control groups which means receiving no training .The basis of conducting this instructional design was the psychological theories of constructivism and active learning. The first and second groups received eight sections of training, 45 minutes each. Participants' behavior was tested, using observation checklist in three parts by an observer in three groups; the search for vehicles on the street, Being cautious of dangers and Crossing the safe place in a real traffic environment in two way street, at three steps: before training, one week and six months after training.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017031333061N1
Registration date: 2017-11-06, 1396/08/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-06, 1396/08/15
Registrant information
Name
Hamide Zare
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 35 3253 4749
Email address
hamide.zare@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-10-16, 1395/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of parental involvement in children education for safe street-crossing skills
Public title
The Impact of Parents involvement in promoting Children's Safe Behavior in Traffic
Purpose
Prevention
Inclusion/Exclusion criteria
Entry criterion: boy student 7-8 years old; Consent form signed by parents Exit: Not attending a test Not attending 2 educations sessions; the child or family's unwillingness to continue to study
Age
From 7 years old to 8 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 136
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tarbiat Modares University
Street address
Al-Ahmad & Chamran Cross, Tehran, Iran
City
Tehran
Postal code
14115-331
Approval date
2015-05-27, 1394/03/06
Ethics committee reference number
IR.TMU.REC.1394.49

Health conditions studied

1

Description of health condition studied
Pedestrian injured
ICD-10 code
V02
ICD-10 code description
Pedestrian injured in collision with two- or three-wheeled motor vehicle

2

Description of health condition studied
Pedestrian injured
ICD-10 code
V03
ICD-10 code description
Pedestrian injured in collision with car, pick-up truck or van

Primary outcomes

1

Description
Search for vehicles on the street -Being cautious of dangers-Crossing the safe place
Timepoint
before, one week after , and after two and six months of receiving education
Method of measurement
observation Behavior Based on traffic rules

Secondary outcomes

empty

Intervention groups

1

Description
The Test group received eight sections of training, 45 minutes , 2 of which were held in actual environment. instructions at school, along with homework and the cooperation of the parents in the learning process.
Category
Behavior

2

Description
The active control group received eight sections of training,45 minutes , 2 of which were held in actual environment at school.
Category
Behavior

3

Description
The control group did not receive any training during the study
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Schools : Seyedoshohada
Full name of responsible person
Hossein Hosseini
Street address
Seyedoshohada
City
Mehriz, Shahid Sadoghi Bulvar, Mehriz, Yazd

2

Recruitment center
Name of recruitment center
Danesh School
Full name of responsible person
Mrs. Jafari
Street address
Danesh School, Mostafa Khomaini Street, Mehriz, Yazd
City
Mehriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Dr.  Mansoureh Movahedin
Street address
Anatomy Dept. Medical Sciences Faculty, Tarbiat Modares University
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Hamide Zare
Position
PHD Student
Other areas of specialty/work
Street address
Health Center-Mehriz- Yazd-Iran
City
Mehriz
Postal code
8981855815
Phone
+98 35 3253 4749
Fax
+98 35 3252 3091
Email
hamide.zare@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Shamsadin Niknamy
Position
Associate Professor
Other areas of specialty/work
Street address
Al-Ahmad & Chamran Cross, Tehran, Iran
City
Tehran
Postal code
331-14115
Phone
+98 21 8288 4547
Fax
+98 82884555
Email
niknamis@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Hamide Zare
Position
PHD Student
Other areas of specialty/work
Street address
Health Center
City
Mehriz
Postal code
8981855815
Phone
+98 35 3253 4749
Fax
Email
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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