The Effect of Educational Intervention Based on Media Literacy on Substance Abuse Prevention among College Students Applying the Integrated Social Marketing Approach: a clinical trial study
The Effect of an Educational Intervention Based on Media Literacy on Substance Abuse Prevention among College Students: Applying the Integrated Social Marketing Approach
Design
A randomized, single-blind, controlled clinical trial with a parallel group design of 116 students, who will be registered and studied from January 2020 to May 2021 and will be followed for three months.
Settings and conduct
This study will be conducted in the universities of medical sciences, Islamic Azad and Bu Ali in Hamadan City. The sample number is 116 students who will be assigned to intervention groups (intervention and control) by random cluster method. The intervention includes five web-based education sessions. The intervention is performed at the universities of the experimental group and three months after the intervention, the questionnaires are completed again and the data obtained from the two groups are analyzed and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria in this study can be: Internet access at least 4 hours per week, Studying at the university, desire to participate in the study (completing the consent form, interview, completing the questionnaire). Exclusion criteria included: Students who are not able to answer the questionnaire and participate in the study, Unwillingness to cooperate to continue participating in the program, Incomplete completion of the questionnaire.
Intervention groups
Students of universities in Hamadan will include students of the University of Medical Sciences, Islamic Azad University of Hamadan and Bu Ali University.
Main outcome variables
Change of substance abuse intention and behavior Scores, media literacy related to substance abuse score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200914048719N1
Registration date:2020-10-06, 1399/07/15
Registration timing:prospective
Last update:2020-10-06, 1399/07/15
Update count:0
Registration date
2020-10-06, 1399/07/15
Registrant information
Name
Hanieh Jormand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0090
Email address
jormand69h@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational Intervention Based on Media Literacy on Substance Abuse Prevention among College Students Applying the Integrated Social Marketing Approach: a clinical trial study
Public title
Effect of an Educational Intervention Based on Media Literacy on Substance Abuse Prevention among College Students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Access to the Internet and Social Networks such as what's app, telegram, and Instagram
Being a student in one of the universities in the city of Hamadan
Being interested in participating in the study
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Using Block randomization (quadruple blocks), individuals are assigned to two groups of intervention and control.
Blinding (investigator's opinion)
Single blinded
Blinding description
Students participating in the study will be placed in intervention or control groups (delayed intervention group) after obtaining informed consent. Trials that are planned in such a way that people are aware of all the aims of the study, based on the planning of the research group, all members of the intervention or control group will have access to all educations. The members of the intervention group will be educated at the beginning and the members of the control group will receive training three months after receiving the post-test results. It is necessary to be mentions, students are unaware of assignments to study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Technology Research, Hamadan University of Medical Sciences
Street address
Department of public health, School of public health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2019-12-28, 1398/10/07
Ethics committee reference number
IR.UMSHA.REC.1398.827
Health conditions studied
1
Description of health condition studied
Substance abuse intention and behavior, media literacy related to substance abuse.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change of Substance Abuse Attitude Score
Timepoint
Before and three months after the intervention
Method of measurement
Researcher made Questionnaire of substance abuse behavior based on Prototype Willingness Model
2
Description
Change of Subjective Norms Score
Timepoint
Before and three months after the intervention
Method of measurement
Researcher made Questionnaire of substance abuse behavior based on Prototype Willingness Model
3
Description
Change of risk Images score
Timepoint
Before and three months after the intervention
Method of measurement
Researcher made Questionnaire of substance abuse behavior based on Prototype Willingness Model
4
Description
Change of substance abuse behavioral willingness score
Timepoint
Before and three months after the intervention
Method of measurement
Researcher made Questionnaire of substance abuse behavior based on Prototype Willingness Model
5
Description
Change of Substance Abuse Media Literacy Score
Timepoint
Before and three months after the intervention
Method of measurement
Researcher made questionnaire
Secondary outcomes
1
Description
Change of Substance Abuse Intention Score
Timepoint
Before and three months after the intervention
Method of measurement
Researcher-made questionnaire
2
Description
Change of substance abuse behavior score
Timepoint
Before and three months after the intervention
Method of measurement
Researcher-made questionnaire
Intervention groups
1
Description
In the intervention group: The educational intervention includes five web based education sessions about substance abuse prevention and substance abuse media literacy. Each session includes 40-45 minutes of training with question and answer methods and group discussion (Chat rooms) will be held with the help of multimedia tools and reminder messages. For example; the first educational session aimed at familiarizing students with Drugs and the consequences of substance abuse, the second session aimed at familiarizing students with substance abuse media literacy skills and critical thinking, and the media consumption regime.The third session aimed at familiarizing Students with interpersonal skills and self-awareness and the fourth session will introduce students to the saying no skills and problem solving.The fifth session will be held to correct students' beliefs and attitudes towards substance abuse with the mentioned web based teaching methods and materials.
Category
Prevention
2
Description
Control group: (delayed intervention group) who did not receive any educational intervention, but in order to comply with research ethics and commitments to blindness, after receiving the results of three months follow up in the intervention group, all educational interventions will be provided to the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences, Islamic Azad University of Hamadan and Bu Ali University.
Full name of responsible person
Hanieh Jormand
Street address
Department of public health, School of public health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0090
Email
jormand69h@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences; Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517619657
Phone
+98 81 3838 0717
Email
Fanavari@umsha.ac.ir
Web page address
http://en.umsha.ac.ir/?p=289
Grant name
Grant code / Reference number
9811018459
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Majid Barati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of public health, School of public health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0090
Email
Barati@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hanieh Jormand
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Department of Public Health, Faculty of Health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0090
Email
jormand69h@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hanieh Jormand
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Department of public health, School of public health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0090
Email
jormand69h@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
6 months after the publication of the article.
To whom data/document is available
All researchers who request data access to one of the authors of the article.
Under which criteria data/document could be used
For further studies.
From where data/document is obtainable
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
What processes are involved for a request to access data/document