Plain English Summary
Background and study aims
Substance abuse is a global youth health problem that has high social and economic burdens. This is a major problem among Saudi youth. The most prevalent substances used by Saudi youth are tobacco, amphetamine, and khat. Although khat use is restricted to the South of the Kingdom of Saudi Arabia, amphetamine and tobacco are used all over the country. Substance abuse is one of the major health problems, causing more deaths, illness, and disabilities than any other preventable cause today. These legal and illegal substances cause many diseases ranging from gastrointestinal disease, psychiatric disorders, cardiovascular, cancers, and many others. They also cause academic under-performance, and negative impacts economically and in terms of the families of students.
Based on other countries experiences where such practice is widely spread, we hypothesise that an effective health campaign to raise awareness about the health effects of the use of khat, amphetamines, and smoking will increase the knowledge about their danger, and consequently decrease their use. A school-based interpersonal communication intervention program (IPC) to raise awareness about the use of khat, amphetamines, and smoking, as derived from the health belief model, will be implemented and evaluated in high schools in Jazan city.
The aim of this study is to assess the effectiveness of the school-based interpersonal communication intervention program (IPC) on the level of knowledge about the health effects of khat, amphetamines and smoking and their use among male students of high schools in Jazan.
Who can participate?
Males aged 15-25 attending high school in Jazan, Saudi Arabia
What does the study involve?
The main concept of this intervention is to focus on peer pressure theory. Three schools will have the main intervention, another three schools will have standard intervention and the last three schools will have intervention about road traffic accidents. The educational campaign will be delivered by students. Selected students will be trained and supervised by the research team, and they will conduct most of the education campaign. This main intervention will involve lectures, brochures and videos. This will be compared to the standard education campaign, conducted by an expert using printed materials, without any interactive sessions or videos. The control group will receive printed materials about road traffic accidents. Participants will complete questionnaires before and after the intervention.
What are the possible benefits and risks of participating?
Information about the harm effect of the substance abuse disseminated during the health education campaign will benefit in the control of substance abuse. Moreover, the national health policy makers will benefit from the receipt of definitive evidence of how to increase awareness and decrease use of substances within communities. There are no known risks to participants taking part in this study.
Where is the study run from?
The study is run from Jazan University and take place in 9 high schools in Jazan, Saudi Arabia
When is the study starting and how long is it expected to run for?
May 2012 to April 2019
Who is funding the study?
Saudi Ministry of Education (Saudi Arabia)
Who is the main contact?
Dr Anwar Makeen
dr.makeen@gmail.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
JAZ00001
Study information
Scientific title
Unblinded cluster-randomised controlled trial on the effect of an interpersonal communication campaign on increasing knowledge and reducing use of khat, amphetamine and tobacco among male students of high schools in Jazan City
Acronym
IPCISA
Study hypothesis
Students aged 14-25 years who are exposed to a high-intensity interpersonal communication campaign will have more knowledge or less substance abuse after six months than students who receive low intense or left untreated.
Ethics approval
Research Ethics Committee at Jazan University, 14/05/2018, ref: REC39/9-S046
Study design
Interventional three-armed unblinded cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
Use of khat, amphetamine and tobacco
Intervention
Current interventions as of 17/01/2019:
This study has 3 arms. Nine male schools in Jazan city will be randomised to one of the three arms using the close envelope technique.
The first arm will receive an intensive dose of the health education campaign, Jazan University Model For Peer Education (JUMP). The second arm will receive a low dose of the health education campaign. The third arm be the control group, and instead receive an educational campaign about road traffic accidents.
Intensive dose of JUMP:
Within schools, the intensive JUMP intervention will take place for one month followed by weekly educational visits for five months. The moderators will be senior students and advisors from high schools who will be trained specifically for this program (training of trainees). The program will be delivered by a student from each school after they have received short training to ensure uniformity of the interventions. The educational material will consist of written material created by a specialized team. The video, lectures and group discussion will be presented in equipped classrooms in each intervention school. The intervention will be given over a period of one month as follows:
1. The lectures will be given by the moderator (instructor) and contain information about the global, regional and local situation regarding khat,
amphetamines and smoking, and talk about that are making these products
2. We will show 3 videos for khat, amphetamine and smoking. The first educational video will provide educational messages about the risks and damages related to the use of psychotropic substances (stimulants and drugs) and methods of prevention in a scientific manner. The second educational video will provide educational messages on the harmful effects of tobacco consumption. Third educational video will present awareness-raising messages about the harmful effects of khat.
3. A printed brochure will be structured to include several components, including risks and damages related to the use of psychotropic substances (stimulants and drugs), tobacco, and khat use.
4. Group discussions will focus on developing two life skills including time management and effective communication
5. Time management will be delivered through one video session that show the target students a motion graphic
6. An interactive activity on (effective communication skill) will be conducted on the form of a pamphlet that contains simple instructions and illustrates practical methods to conduct an interactive activity session that on skill of effective communication.
Low dose of JUMP:
All printed materials will be distributed for all students in this arm, without interactive session and videos. Baseline data will be collected before the intervention and follow up after 24 weeks.
Control group:
Printed materials about road traffic accidents will be distributed for all students in this arm. Baseline data will be collected before the intervention and follow up after 24 weeks.
Previous interventions:
This study has 3 arms. Nine male schools in Jazan city will be randomised to one of the three arms using the close envelope technique.
The first arm will receive an intensive dose of the health education campaign. The second arm will receive a low dose of the health education campaign. The third arm be the control group, and instead receive an educational campaign about road traffic accidents.
Intensive dose of health education campaign:
Within schools, the intensive health education campaign intervention will take place for one month followed by weekly educational visits for five months. The moderators will be senior students and advisors from high schools who will be trained specifically for this program (training of trainees). The program will be delivered by a student from each school after they have received short training to ensure uniformity of the interventions. The educational material will consist of written material created by a specialized team. The video, lectures and group discussion will be presented in equipped classrooms in each intervention school. The intervention will be given over a period of one month as follows:
1. The lectures will be given by the moderator (instructor) and contain information about the global, regional and local situation regarding khat,
amphetamines and smoking, and talk about that are making these products
2. We will show 3 videos for khat, amphetamine and smoking. The first educational video will provide educational messages about the risks and damages related to the use of psychotropic substances (stimulants and drugs) and methods of prevention in a scientific manner. The second educational video will provide educational messages on the harmful effects of tobacco consumption. Third educational video will present awareness-raising messages about the harmful effects of khat.
3. A printed brochure will be structured to include several components, including risks and damages related to the use of psychotropic substances (stimulants and drugs), tobacco, and khat use.
4. Group discussions will focus on developing two life skills including time management and effective communication
5. Time management will be delivered through one video session that show the target students a motion graphic
6. An interactive activity on (effective communication skill) will be conducted on the form of a pamphlet that contains simple instructions and illustrates practical methods to conduct an interactive activity session that on skill of effective communication.
Low dose of health education campaign:
All printed materials will be distributed for all students in this arm, without interactive session and videos. Baseline data will be collected before the intervention and follow up after 24 weeks.
Control group:
Printed materials about road traffic accidents will be distributed for all students in this arm. Baseline data will be collected before the intervention and follow up after 24 weeks.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Current:
The following will be assessed using the Youth Tobacco, Khat and Amphetamine Prevalence and Knowledge Questionnaire at the baseline, 12 and 36 week follow-up:
1. Proportion of participants who report using khat, amphetamines or smoking tobacco products (each substance will be considered individually, as well as aggregated use)
2. Proportion of participants who report having knowledge about the harmful effects of khat, amphetamines or smoking tobacco products (each substance will be considered individually, as well as aggregated use)
Previous:
The following will be assessed using the Youth Tobacco, Khat and Amphetamine Prevalence and Knowledge Questionnaire at the baseline and at the 24 week follow-up:
1. Proportion of participants who report using khat, amphetamines or smoking tobacco products (each substance will be considered individually, as well as aggregated use)
2. Proportion of participants who report having knowledge about the harmful effects of khat, amphetamines or smoking tobacco products (each substance will be considered individually, as well as aggregated use)
Secondary outcome measures
Current:
Changes in the following will be assessed using the Youth Tobacco, Khat and Amphetamine Prevalence and Knowledge Questionnaire at the baseline, 12 and 36 week follow-up:
1. Proportion of participants who perceive the dangers of khat, amphetamine and tobacco, yet still report using substances (each substance will be considered individually, as well as aggregated perceptions)
2. Proportion of participants who have quit using khat, amphetamine and tobacco at 6 months (this will be split into years ago and since the onset of the intervention)
Previous:
Changes in the following will be assessed using the Youth Tobacco, Khat and Amphetamine Prevalence and Knowledge Questionnaire at the baseline and the 24 week follow-up:
1. Proportion of participants who perceive the dangers of khat, amphetamine and tobacco, yet still report using substances (each substance will be considered individually, as well as aggregated perceptions)
2. Proportion of participants who have quit using khat, amphetamine and tobacco at 6 months (this will be split into years ago and since the onset of the intervention)
Overall trial start date
10/05/2012
Overall trial end date
20/01/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Enrolled in one of the selected schools
2. Aged 15-25
3. Willing and able to provide informed consent
4. Proxy consent from guardians
Participant type
Other
Age group
Adult
Gender
Male
Target number of participants
2625
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
04/11/2018
Recruitment end date
31/01/2019
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
Al razi school
Alhassan Albasry Street
Jazan
8272
Saudi Arabia
Trial participating centre
Al Ahfad Private School
25th Street
Jazan
82812
Saudi Arabia
Trial participating centre
Prince Abdullah Alfisal School
Ibn Alqayem Street
Jazan
82617
Saudi Arabia
Trial participating centre
Manarat Almajed Private School
3330 Prince Metibb Bin Abdul Aziz Road
Jazan
82812
Saudi Arabia
Trial participating centre
Khwarizmi High School
Ibn Kholdon Street
Jazan
82812
Saudi Arabia
Trial participating centre
Moa'ad Bin Jabal High School
As Suways
King Abdullah Street
Jazan
82616
Saudi Arabia
Trial participating centre
Alrawdah School
Prince Fawaz Bin Abdulazis Street
Alrawdah District
Jazan
82727
Saudi Arabia
Trial participating centre
Al Maarfa Private School
19th D Street
Jazan
82731
Saudi Arabia
Trial participating centre
Al Karbous School
2691 King Faysal Road
Al Arak
7653
Jazan
82635
Saudi Arabia
Sponsor information
Organisation
Jazan University
Sponsor details
Block 8
Jazan University campus
Jazan
45142
Saudi Arabia
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Ministry of Education Saudi Arabia
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results will be disseminated at scientific conferences, seminars and presentations, and by publication in peer-reviewed scientific journals.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
20/01/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list