Plain English Summary
Background and study aims
Recent studies showed that the popularity of tobacco smoking, particularly waterpipe, is high among Jordanian school students, but no school-based interventions to discourage waterpipe smoking have been tested. This study aims to test the effectiveness of a behavioral counseling waterpipe smoking cessation program using the 5As guidelines directed toward waterpipe-smoking Jordanian school students.
Who can participate?
Students enrolled in grade 9, 10, 11, or 12 who report smoking at least one puff of waterpipe in the last 30 days.
What does the study involve?
Eight schools from Zarqa Governorate First Educational District will be recruited to participate in the study and will be randomly allocated to deliver either a school-based counseling intervention or to hand out informational pamphlets regarding smoking cessation. Students will be assessed at the start of the study and 1, 3 and 6 months later to assess the short- and long-term effects of the intervention.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Zarqa Governorate First Educational District schools (Jordan).
When is the study starting and how long is it expected to run for?
March 2015 to April 2016.
Who is funding the study?
American University of Beirut (Lebanon).
Who is the main contact?
Dr Sukaina Alzyoud
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
School-based waterpipe smoking cessation intervention program among Jordanian adolescents: a randomized controlled trial
Acronym
Study hypothesis
To demonstrate a significantly 2.63, 2.99 and 4.01% increase in waterpipe smoking abstinence rates, defined as the percentage reporting no waterpipe smoking in the last 30 days, among students in the intervention compared to control schools at 1-, 3-, and 6-months follow-up assessments.
Ethics approval
Institutional Review Board - The Hashemite University, 26/03/2015
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Condition
Waterpipe smoking among youth
Intervention
Study intervention Includes two arms:
School-Based Counseling Intervention (CI)
The CI is based on the 5As intervention model, it is based on the Social Cognitive Theory [SCT] which incorporates cognitive-behavioral principles and posits that behavior and behavior change involve the following:
1. Knowledge of the risks and benefits of a behavior
2. Outcome expectations, that is expectations about positive and negative outcomes anticipated for the behavior, which are learned from prior experience, observing others, hearing about similar situations from others, and emotional or physical responses to the behavior
3. Self-control, or the ability to engage in goal-directed behavior including goal-setting, self-monitoring, problem-solving and self-reward
4. Behavioral capability, the knowledge and skills necessary to perform the given behavior to meet goals established, including addressing barriers to successfully engaging in the behavior
5. Self-efficacy, confidence in one’s ability to successfully perform the behavior, including confidence in overcoming anticipated barriers.
Description of the Information Only (IO)
Students in the IO schools will have four weekly visits with the school counselor over the course of a month (equivalent to the CI condition). During these visits the school counselor will deliver a series of informational pamphlets regarding smoking and cessation (4 total) that was developed by the Jordanian Ministry of Health, check waterpipe smoking status and efforts at quitting, and ask if the student has any questions.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Variables will be measured using questionnaires:
1. Waterpipe smoking in last 30 days: measured at baseline and 1-, 3- and 6-months follow-up
2. Waterpipe smoking in last 48 hours: measured at baseline and 1-, 3- and 6-months follow-up
3. Waterpipe smoking in last 24 hours : measured at baseline and 1-, 3- and 6-months follow-up
4. # of waterpipe smoking in last 30 days: measured at baseline and 1-, 3- and 6-months follow-up
5. Frequency of waterpipe smoking in last 30 days: measured at baseline and 1-, 3- and 6-months follow-up
6. Awareness of smoking health risks: measured at baseline and 1-, 3- and 6-months follow-up
7. Quit attempts: measured at baseline and 1-, 3- and 6-months follow-up
Secondary outcome measures
Cotinine assessment using cotinine saliva testing will be measured at baseline and 1-, 3- and 6-months follow-up
Overall trial start date
01/03/2015
Overall trial end date
30/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Enrolled in grade 9, 10, 11, or 12 at the time of study enrollment
2. Reporting smoking at least one puff of waterpipe in the last 30 days
3. Reporting willingness to participate in a smoking cessation intervention study
4. Able to complete the baseline questionnaire independently, indicating ability to complete study assessments and protocols
5. Intending to remain enrolled in the school for the remainder of the school year
6. Willing to provide contact information for the next 6 months
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
Around 240
Participant exclusion criteria
None waterpipe smokers
Recruitment start date
25/08/2015
Recruitment end date
30/09/2015
Locations
Countries of recruitment
Jordan
Trial participating centre
Zarqa Governorate First Educational District schools
13133
Jordan
Funders
Funder type
University/education
Funder name
American University of Beirut (Lebanon)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Other
Basic results (scientific)
Publication list