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The effect of educational intervention based on Precede-Proceed model on the stress management of Adolescent students girls in Rasht year 2016-2017

Protocol summary

Summary
The present study is an interventional randomized controlled trial (RCT) study that will be implemented to assess the impact of educational intervention based on factors predisposing PRECEDE PROCEED MODEL on stress management of girl high school students in Rasht. Sampling has been done by multistage random sampling in girl secondary schools. Thus, one high school will be selected as intervention and the other as a control. The sample size of 142 subjects (71 intervention group and 71 control group) will be considered. The instruments for data collection consisted of 4 questionnaires: Demographic- Self-made questionnaire within the framework of PRECEDE structures - Stress coping behavior questionnaire, stress management, Adolescent Lifestyle Questionnaire, inclusion criteria, students voluntary participation in the study and written consent of students and their parents, exclusion criteria, not wanting to continue the study and the absence of classroom training in more than two sessions. The steps of the research will be carried out based on PRECEDE PROCEED MODEL. Method: out of tenth grade students from two girls secondary schools, 142 subjects will be under pre-test in order to plan educational needs and to determine the concerned structures that should be more considered in the training sessions and teaching methods and the number of training sessions. Again, one and a half months after intervention, the test (Questionnaires 2, 3, 4) will be taken from both the intervention and control groups. Finally, the results were presented to Guilan University of Medical Sciences.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011431936N1
Registration date: 2017-02-17, 1395/11/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-02-17, 1395/11/29
Registrant information
Name
Fariba Asgari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5056
Email address
asgari_f@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-04-09, 1396/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of educational intervention based on Precede-Proceed model on the stress management of Adolescent students girls in Rasht year 2016-2017
Public title
The effect of educational intervention based on Precede-Proceed model on the stress management of Adolescent students girls in Rasht year 2016-2017
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria for students: volunteer in the study; completed questionnaires and written consent of students and their parents. Exclusion criteria: Change school and classroom study; not wanting to continue the study,the absence of classroom training in more than two sessions.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 142
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

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Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology University of Medical Sciences
City
Rasht
Postal code
Approval date
2016-12-24, 1395/10/04
Ethics committee reference number
IR.GUMS.REC.1395.295

Health conditions studied

1

Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders

Primary outcomes

1

Description
The stress
Timepoint
Before intervention ,1/5 Months after intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In control group, at first pre-test was received but there is no intervention. Finally, along with intervention groups, the test also was taken from this group
Category
Prevention

2

Description
In intervention group: After carrying out needs assessments and determining the structures that need to be more considered, according to PRECEDE PROCEED MODEL, stress management training sessions by researchers and psychologists in one and a half hour sessions will be presented. One and a half months after the end of training, a test will be taken from both test and control groups and the results will be studied.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Selected two middle schools
Full name of responsible person
Fariba Asgari
Street address
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr.Shadman Nemati
Street address
Research and Technology affairs building, in front of Sepah Bank, West Beheshti blvd, Rasht Rasht Guilan Iran, Islamic Republic Of
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Fariba Asgari
Position
Faculty member
Other areas of specialty/work
Street address
Nursing and midwifery school, Daneshjo park., Beheshti Highway, Rasht.
City
Rasht
Postal code
Phone
+98 13 3355 5056
Fax
Email
asgari.frb@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Fariba Asgari
Position
Faculty member
Other areas of specialty/work
Street address
Nursing and midwiffery school, Daneshjo park., Beheshti Highway, Rasht
City
Rasht
Postal code
Phone
+98 13 3355 5056
Fax
Email
asgari.frb@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Zhila Parsa
Position
Masters student
Other areas of specialty/work
Street address
City
Rasht
Postal code
Phone
Fax
Email
shivaparsa8@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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