Protocol summary

Study aim
Determining the effect of a curriculum based on self-regulation theory in the prevention of alcohol consumption in second grade high school male students in the south of Kerman province
Design
Clinical trial with control group, with paralell Two-way blinded, randomized, phase 2 and were performed on 420 students (210 in the intervention group, 210 in the control group). Cluster sampling is multi-stage and 2 high schools from each city and 1 class from each high school are randomly selected. A total of 14 classes are randomly selected
Settings and conduct
all second grade male high school students in 7 cities under the auspices of Jiroft University of Medical Sciences (south of Kerman) in the academic year 1398-1399. Jiroft, after obtaining informed consent to participate in research, the proposal to hold at least 6 sessions of intervention (experimental group) for 10 weeks will be shared with them
Participants/Inclusion and exclusion criteria
Inclusion : second grade of high school, boys and natives of the region and exclusion : lack of cooperation and unwillingness to participate in the study
Intervention groups
1: Collection of data related to alcohol prevention based on the studied structures. 2: Prepare an intervention program based on the stages of self-regulation theory (the intervention is intended to use at least 6 training sessions for 10 weeks to prevent alcohol use using self-regulation theory Will be taken.) Third stage: Performing educational intervention 4: Performing intervention program and no intervention was performed in the control group.
Main outcome variables
Behavioral inhibition; Effective memory; Internal conversation; Motivational assessment; Behavioral reconstruction; alcohol consumption

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200923048817N1
Registration date: 2020-10-26, 1399/08/05
Registration timing: prospective

Last update: 2020-10-26, 1399/08/05
Update count: 0
Registration date
2020-10-26, 1399/08/05
Registrant information
Name
Ehsan Movahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3213 3151
Email address
ehsanmovahed89@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-02-28, 1399/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of educational program based on Self-regulation Theory on prevention of alcohol use among Secondery high school male students in southern area of Kerman
Public title
Evaluation the effect of educational program based on Self-regulation Theory on prevention of alcohol use among Secondery high school male students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Second grade of high school boy natives of the region
Exclusion criteria:
Lack of cooperation to participate in the study
Age
From 16 years old to 17 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 420
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population includes second grade high school male students in 7 cities under the auspices of Jiroft University of Medical Sciences (south of Kerman) in the academic year 2010-2011. The sampling method is cluster-multi-stage sampling. Sampling is that 2 high schools from each city and 1 class from each high school are randomly selected. A total of 14 classes are randomly selected. After that, in each high school, one class is considered as the experimental group and one class as the control group, and finally 7 classes are divided as the experimental group and 7 classes as the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants were unaware of the allocation in groups after consenting to participate in the study and knowledge of the purpose of the study. Data collectors and those evaluating the outcome were also unaware of the allocation of students in the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Intervention based on the structures of self-regulatory theory

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jiroft University of Medical Sciences
Street address
Pasdaran Blvd
City
Jiroft
Province
Kerman
Postal code
7618746864
Approval date
2020-02-20, 1398/12/01
Ethics committee reference number
IR.JMU.REC.1398.071

Health conditions studied

1

Description of health condition studied
alcohol use
ICD-10 code
F10.1
ICD-10 code description
Alcohol abuse

Primary outcomes

1

Description
Behavioral inhibition
Timepoint
Before and after the intervention
Method of measurement
researcher-made questionnaire (behavioral inhibition)

2

Description
Effective memory
Timepoint
Before and after the intervention
Method of measurement
Researcher-made questionnaire (effective memory)

3

Description
Internal dialogue
Timepoint
Before and after the intervention
Method of measurement
Researcher-made questionnaire (internal conversation)

4

Description
Motivational assessment;
Timepoint
Before and after the intervention
Method of measurement
Researcher-made questionnaire (motivational assessment)

5

Description
Behavioral reconstruction
Timepoint
Before and after the intervention
Method of measurement
Researcher-made questionnaire (behavioral reconstruction)

Secondary outcomes

empty

Intervention groups

1

Description
The intervention is such that at least 6 training sessions (45 to 60 minutes each session according to the participants) are used during 10 weeks to prevent alcohol consumption using self-regulatory theory. The first session to increase knowledge and skills with lectures and questions and answers, the second session with increasing people's self-confidence through self-efficacy and performing behavioral inhibition behavior skills from short educational videos, setting up an exhibition, the third session on effective memory, which includes the ability Store and recall useful information to solve the problem. That can be activated in people with the ability to save and remember by reporting and working on a specific project or content. The fourth session is accompanied by an internal dialogue so that by expressing the inner feelings and emotions of the participants, as much as possible, people can be led to their situation, where they are and where they want to go. The fifth session is about motivational assessment: the person tries to create a hypothetical future by emotionally and motivationally evaluating past events in effective memory. By evaluating the desirable situation of people in the past and by remembering them, a bright future in people's lives can be imagined. Sixth session, including behavioral reconstruction (behavioral synthesis), should be done by analyzing or separating the past behavioral structure and their hierarchy and rearranging the past behavior and creating new behaviors with a new structure and new sequence. Encouraged in people.
Category
Prevention

2

Description
Control group: No intervention is made
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
High schools in the south of Kerman
Full name of responsible person
Ehsan Movahed
Street address
Pasdaran
City
Jiroft
Province
Kerman
Postal code
7618746864
Phone
+98 34 4331 7802
Email
Ehsanmovahed89@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Fatemeh seyedi
Street address
Pasdaran
City
Jiroft
Province
Kerman
Postal code
7618746864
Phone
+98 34 4331 7802
Email
ehsanmovahed89@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jeeroft University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Ehsan Movahed
Position
expert in Department of research
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Pasdaran
City
Jiroft
Province
Kerman
Postal code
7618746864
Phone
+98 34 4331 7802
Email
ehsanmovahed89@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Ehsan Movahed
Position
Expert in Department of research
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
pasdaran
City
Jiroft
Province
Kerman
Postal code
7618746864
Phone
+98 34 4331 7802
Email
ehsanmovahed89@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Ehsan Movahed
Position
expert in health
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Pasdaran
City
Jiroft
Province
Kerman
Postal code
7618746864
Phone
+98 34 1331 7802
Email
ehsanmovahed89@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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