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
| ISRCTN | ISRCTN71720191 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71720191 |
| Secondary identifying numbers | JAZ00001 |
- Submission date
- 09/10/2018
- Registration date
- 16/10/2018
- Last edited
- 17/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
6285 - villa B11
Faculty Housing, Jazan University
Jazan
82912
Saudi Arabia
Study information
| Study design | Interventional three-armed unblinded cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| 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 |
| Study acronym | IPCISA |
| Study objectives | 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(s) | Research Ethics Committee at Jazan University, 14/05/2018, ref: REC39/9-S046 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 10/05/2012 |
| Completion date | 20/01/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 2625 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 04/11/2018 |
| Date of final enrolment | 31/01/2019 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centres
Jazan
8272
Saudi Arabia
Jazan
82812
Saudi Arabia
Jazan
82617
Saudi Arabia
Jazan
82812
Saudi Arabia
Jazan
82812
Saudi Arabia
King Abdullah Street
Jazan
82616
Saudi Arabia
Alrawdah District
Jazan
82727
Saudi Arabia
Jazan
82731
Saudi Arabia
Al Arak
7653
Jazan
82635
Saudi Arabia
Sponsor information
University/education
Block 8, Jazan University campus
Jazan
45142
Saudi Arabia
| Website | http://www.jazanu.edu.sa/Pages/Default.aspx |
|---|---|
"ROR" |
https://ror.org/02bjnq803 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 20/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
17/01/2019: The study interventions have been changed
16/01/2019: The following changes have been made to the trial record:
1. The recruitment end date has been changed from 02/12/2018 to 31/01/2019.
2. The overall trial end date has been changed from 29/04/2019 to 20/01/2020.
3. The intention to publish date has been changed from 20/08/2020 to 20/01/2021.
4. The primary outcome measures have been changed.
5. The secondary outcome measures have been changed.
24/10/2018: Internal review.
