Intervention for Adolescent Tobacco Initiation Prevention
NCT ID: NCT06399588
Last Updated: 2024-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1280 participants
INTERVENTIONAL
2024-05-02
2024-12-31
Brief Summary
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Detailed Description
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Design: Pilot feasibility school-based cluster randomized controlled trial.
Setting: Secondary schools in Dhaka city, Bangladesh.
Participants: Adolescents in school years 8 and 9 attending participating schools in Dhaka (K = 8 clusters; N\~1280 participants).
Intervention: The intervention consists of three 40-minute sessions, delivered over three successive days, including knowledge and skill-based lectures, interactive activities, and materials targeting tobacco prevention and health promotion. This intervention was developed based on evidence gathered from a quantitative survey, qualitative focus groups, and a systematic review.
Measurements: The primary outcome is the feasibility of the intervention, assessed with recruitment and attrition rates, fidelity of delivery and acceptability. Secondary outcomes include the change in intention to initiate tobacco use; tobacco knowledge, attitudes, and beliefs; skills development related to tobacco resistance; and the promotion of mental well-being. Data will be collected through structured questionnaires administered at baseline and 1-month follow-up assessments for both intervention and control groups. A post-intervention process evaluation will be conducted among the students who participated in the intervention and the teachers using a mixed-method approach, incorporating both questionnaires and semi-structured interviews, to gain insights into intervention implementation, facilitation, participant experiences, and identify potential areas for improvement.
Comments: This pilot feasibility trial addresses a critical gap in tobacco prevention initiatives tailored for Bangladeshi school adolescents. By combining evidence-based strategies, IATIP aims to empower adolescents with the knowledge and skills needed to resist tobacco initiation, while also targeting specific components to improve health and well-being, recognising the interconnected challenges of tobacco use and health and well-being among adolescents. Successful implementation of this pilot trial has the potential to reduce the intention to initiate tobacco use, limit exposure to second-hand smoke, and contribute to the overall health and well-being of school adolescents. Given the scalability of school-based interventions, the trial's success may pave the way for future large-scale definitive trials, influencing national policies and strategies.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention group
The intervention consists of three 40-minute sessions, delivered over three successive days, including knowledge and skill-based lectures, interactive activities, and materials targeting tobacco prevention and health promotion.
Intervention for Adolescent Tobacco Initiation Prevention (IATIP)
The IATIP is an evidence-based tobacco prevention program tailored for Bangladeshi adolescents, integrating Behavior Change Techniques, the Behavior Change Wheel, and the Theoretical Domains Framework. Utilizing the Arena Blended Connected (ABC) model ensures effective delivery. Six key learning types are integrated to optimize knowledge acquisition, concept exploration, collaboration, discussions, practical application, and skill development. The curriculum comprises three core components addressing adolescents' challenges: the information curriculum cultivates factual awareness, the social competence curriculum strengthens refusal skills and social competencies, and the social influence curriculum builds resilience against tobacco-promoting social influences.
Control group
Participating schools in the control group will maintain their regular ongoing activities without introducing the IATIP. Students in the control group will not receive any specific anti-tobacco or health and well-being promotion materials beyond their standard school curriculum.
No interventions assigned to this group
Interventions
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Intervention for Adolescent Tobacco Initiation Prevention (IATIP)
The IATIP is an evidence-based tobacco prevention program tailored for Bangladeshi adolescents, integrating Behavior Change Techniques, the Behavior Change Wheel, and the Theoretical Domains Framework. Utilizing the Arena Blended Connected (ABC) model ensures effective delivery. Six key learning types are integrated to optimize knowledge acquisition, concept exploration, collaboration, discussions, practical application, and skill development. The curriculum comprises three core components addressing adolescents' challenges: the information curriculum cultivates factual awareness, the social competence curriculum strengthens refusal skills and social competencies, and the social influence curriculum builds resilience against tobacco-promoting social influences.
Eligibility Criteria
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Inclusion Criteria
* Students at one of the participating schools
* Students of Years 8 and 9
Exclusion Criteria
* don't understand and read the 'Bangla' language
* don't have parental consent
11 Years
17 Years
ALL
Yes
Sponsors
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Commonwealth Scholarship Commission
UNKNOWN
University College, London
OTHER
Responsible Party
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Sahadat Hossain
Principal Investigator
Principal Investigators
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Sahadat Hossain, MSPH
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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Secondary schools
Dhaka, , Bangladesh
Countries
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Central Contacts
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Other Identifiers
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22645/004
Identifier Type: -
Identifier Source: org_study_id
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