Protocol summary
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Study aim
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Design, implementation and evaluation of an interventional program on aggressive behaviors among primary school students in Kermanshah
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Design
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In this study, among schools with the highest aggression, 280 aggressive students are eligible to enter the study. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
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Settings and conduct
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Interventions will be taken to prevent and reduce aggression in Kermanshah and in the school environment.Participants are randomly divided into two groups of intervention and control. Interventions will be provided in the intervention group
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Participants/Inclusion and exclusion criteria
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inclusion criteria:Students without psychological problems students in schools in Kermanshah; exclusion criteria:Having acute mental illness
Rural students
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Intervention groups
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Intervention group: Male and female students in elementary schools with high aggression levels that receive interventions to reduce aggression
Control group: Male and female students in elementary schools that do not receive any intervention.
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Main outcome variables
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Social competence; physical aggression; verbal aggression; relational aggression; knowledge; outcome expectations; outcome expectancies
; self-efficacy; observational learning; social impacts; social support
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151112025014N3
Registration date:
2018-01-21, 1396/11/01
Registration timing:
registered_while_recruiting
Last update:
2018-01-21, 1396/11/01
Update count:
1
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Registration date
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2018-01-21, 1396/11/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-01-10, 1396/10/20
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Expected recruitment end date
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2019-04-09, 1398/01/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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effectiveness of an intervention on aggressive behaviors in elementary students
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Public title
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effectiveness of an intervention on aggressive behaviors in elementary students
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Students who studying in elementary schools in the Second course
Students who studying at the Kermanshah City Schools.
Students who have no acute psychological problem.
Students whose parents are satisfied with their child's participation in the study.
Exclusion criteria:
Mental illness confirmed by a doctor
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Age
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From 9 years old to 13 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
280
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, stratified random sampling method will be used and the sample classes studied will be based on the gender of students (boy / girl), school status in terms of implementation of the program of health promoting schools(health promotion / non-promotion schools) and the region Urban (semi-possessed / disadvantaged) will be selected. Then the list of schools and the number of elementary students in the second course of the city of Kermanshah will be collected from the Department of Education. The required sample, in terms of student size and the number of schools in each class, will be selected by table of random numbers and by considering the different economic status.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Participants are unaware of the allocation of study groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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In this study, an ecological model (individual, interpersonal, organizational, and policy levels) will be used to explore the various components of the whole school approach in prevention of aggression.
Ethics committees
1
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Ethics committee
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Approval date
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2017-12-16, 1396/09/25
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Ethics committee reference number
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IR.UMSHA.REC.1396.638
Health conditions studied
1
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Description of health condition studied
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aggression
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Physical aggression
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Timepoint
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Before intervention, 7 days after intervention and 6 months after intervention
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Method of measurement
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Adolescent Peer Relations Instrument
2
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Description
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Verbal aggression
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Timepoint
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Before intervention, 7 days after intervention and 6 months after intervention
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Method of measurement
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Adolescent Peer Relations Instrument
3
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Description
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Relational aggression
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Timepoint
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Before intervention, 7 days after intervention and 6 months after intervention
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Method of measurement
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Adolescent Peer Relations Instrument
4
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Description
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knowledge
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Timepoint
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Before intervention, 7 days after intervention and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
5
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Description
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outcome expectations
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Timepoint
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Before intervention, 7 days after intervention and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
6
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Description
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outcome expectancies
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Timepoint
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Before intervention, 7 days after intervention and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
7
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Description
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self-efficacy
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Timepoint
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Before intervention, 7 days after intervention and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
8
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Description
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social support
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Timepoint
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Before intervention, 7 days after intervention and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
9
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Description
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Social impacts
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Timepoint
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Before intervention, 7 days after intervention and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
Secondary outcomes
1
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Description
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Social competence
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Timepoint
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Before intervention, 7 days after intervention and 6 months after intervention
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Method of measurement
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Social competence questionnaire
Intervention groups
1
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Description
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Intervention group: 5 Educational sessions; 10 sessions of psychological counseling; educational booklet; poster and educational banner;Role playing
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Category
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Behavior
2
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Description
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Control group: This group does not receive any intervention.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available