Effectiveness of a School-based Tobacco Prevention Program for Middle School Students in Saudi Arabia

Study Overview
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Brief Summary
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This study evaluated a school-based tobacco program, Dentists Fighting Nicotine Dependence (DFND), to prevent the initiation of tobacco use among middle school students in Saudi Arabia using a social competences/social influence approaches.

Detailed Description
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A quasi-experimental controlled trial design was utilized. Eight middle schools were selected from the regional education registry; four allocated to treatment arm and four to control arm. A total of 28 seventh grade classes were included in the study; 14 served as treatment and 14 as control arms. All students present in these classes on the initial visit were invited to take part in the study [Treatment=379; Control=255]. The treatment arm received the new tobacco prevention program (DFND) whereas the control arm received only the regular tobacco prevention program administered by the Department of Education. DFND was delivered by trained health educators over 5 weeks, two sessions per week. Two follow up surveys were administered; at one week and at two years post-intervention. Study outcomes were current tobacco use, knowledge about tobacco, attitude toward not using tobacco, and perceived behavioral control (PBC) of tobacco use. Covariates included sex, parent education, academic performance, absenteeism, student allowance, and religiosity.

Official Title
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Effectiveness of a School-based Tobacco Prevention Program for Middle School Students in Saudi Arabia: A Controlled Trial.

Conditions
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Tobacco Use

Intervention / Treatment
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* Behavioral: DFND Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Students in 7th grade Gave verbal assent Exclusion Criteria: no assent

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A quasi-experimental, controlled trial design was utilized to evaluate the effectiveness of a school-based tobacco program, Dentists Fighting Nicotine Dependence (DFND), to prevent the initiation of tobacco use among middle school students (grades 7-9) in Jeddah, Saudi Arabia. Eight middle schools were selected from the regional education registry; four allocated to treatment arm (n=379) and four to control arm (n=255). The treatment arm received the new tobacco prevention program (DFND) whereas the control arm received only the regular tobacco prevention program administered by the Department of Education. DFND was delivered by trained health educators over 5 weeks, two sessions per week.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DFND Program<br>Dentist Fighting Nicotine Dependence, (DFND) intervention program consisted primarily of a 10-session curriculum, each session lasting about an hour. The curriculum was comprehensive and incorporated information about tobacco and its adverse health effects, social influences, and social competence skills. DFND was administered over 5 weeks, at a rate of 2 sessions per week. Each session lasts an hour. Fourteen classrooms in four schools represented the experimental arm and received DFND. | Behavioral: DFND Program<br>* The DFND program consisted primarily of a 10-session curriculum, each session lasting about an hour. The curriculum was comprehensive and incorporated information about tobacco and its adverse health effects, social influences, and social competence skills.<br>|
| No Intervention: Informational Booklet<br>Fourteen classrooms in four schools represented the No Intervention arm (control). They received only an informational booklet about tobacco adverse health effects. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline prevalence of tobacco use at one week and at 2 years [Questionnaire] | Questionnaire administered one week and 2 years post-intervention: current use of tobacco | One week and Two years after the completion of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline knowledge about tobacco at one week and at 2 years [Questionnaire] | Questionnaire administered at one week and 2 years: true/false statements on tobacco and its health effects | One week and two years after the completion of the intervention | 
| Change from baseline in perceived behavioral control at one week and at 2 years [Questionnaire] | Questionnaire administered at one week and 2 years: a series of control beliefs about tobacco use | One week and two years after the completion of the intervention | 
| Change from baseline in attitude towards not using tobacco at one week and at two years[Questionnaire] | Questionnaire administered at one week and two years: a series of attitudinal beliefs about tobacco use | One week and two years after the completion of the intervention |