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

Not Applicable

Completed

• Conditions: Tobacco Use
• Interventions: Behavioral: DFND Program

• Registration Number: NCT03579355
• Lead Sponsor: King Abdulaziz University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-02-10
• Primary Completion: 2012-03-30
• Study Completion: 2014-04-15
• Status Verified: 2018-06
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-25
• Last Update Submitted: 2018-06-25
• Study First Posted: 2018-07-06
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 634

Inclusion Criteria

• Students in 7th grade
• Gave verbal assent

Exclusion Criteria

• no assent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DFND Program	DFND Program	"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.

Primary Outcome Measures

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

Secondary Outcome Measures

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