Protocol summary
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Study aim
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Determining the effect of educational intervention based on self-regulation theory on the risk-taking of female students of the first secondary school in Esfarayen
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Design
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A semi-experimental study with two experimental and control groups, on 90 first-year secondary school girls
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Settings and conduct
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This study is aimed at the effect of education based on self-regulation theory on the risk-taking of female students Esfarayen city. In this study, students are selected and entered into the study using a multi-stage random sampling method. In this way, girls' secondary schools of the first period were first selected, then two schools were randomly selected by lottery and given the social and economic similarity in an area with an acceptable geographical distance from each other and were assigned to the test group and the control group. is assigned. Then, qualified female students are selected from each school and entered into the study.
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Participants/Inclusion and exclusion criteria
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First high school girl students
Consent to participate in the study
Having a normal mental state
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Intervention groups
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In this study, in order to determine the effect of education based on self-regulation theory on the risk-taking of female high school students of the first year of Esfarayen, educational sessions are conducted on 45 students in the test group, and the control group does not receive any educational intervention.
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Main outcome variables
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Risk-taking, self-regulation
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:
IRCT20231125060167N1
Registration date:
2023-11-27, 1402/09/06
Registration timing:
prospective
Last update:
2023-12-03, 1402/09/12
Update count:
1
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Registration date
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2023-11-27, 1402/09/06
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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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2023-12-17, 1402/09/26
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Expected recruitment end date
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2024-03-16, 1402/12/26
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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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The effect of education based on self–regulation theory on risk-taking in female students in Eesfarayen city
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Public title
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The effect of education based on self–regulation theory on risk-taking in female students in Eesfarayen city
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
First high school girl students
Consent to participate in the study
Having a normal mental state
Exclusion criteria:
Unwillingness to continue cooperation in the study
Students who change schools for any reason during their studies
Students who drop out during their studies
The occurrence of unfortunate events during the study for the target group (death of students)
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Age
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From 13 years old to 15 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Students are selected and entered into the study using a multi-stage random sampling method. In this way, first the secondary girls' schools of the first period of selection, then two schools, taking into account the social and economic similarity in an area with an acceptable geographical distance from each other, were randomly selected by lottery and assigned to the test group and the control group. It will be given.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-04-29, 1402/02/09
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Ethics committee reference number
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IR.MUMS.FHMPM.REC.1402.025
Health conditions studied
1
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Description of health condition studied
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Risk taking (risky behaviors)
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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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Self-regulation, risk-taking
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Timepoint
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In this study, the measurement is done in three stages, before the intervention, compared to before the intervention, three months after the intervention
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Method of measurement
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In this study, a questionnaire is used to measure the variable
Intervention groups
1
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Description
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Intervention group:
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Category
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Prevention
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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Mashhad 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