Clinical trial NCT06399588: Intervention for Adolescent Tobacco Initiation Prevention
Official title: Intervention for Adolescent Tobacco Initiation Prevention (IATIP) to Promote Health and Well-being: A Protocol for a Pilot Feasibility Cluster Randomised Controlled Trial in Dhaka, Bangladesh
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health Behaviour
Tobacco Prevention
Well-being
Keywords: Adolescent
Tobacco initiation
Health and Well-being
Prevention
School-based intervention
C-RCT
Bangladesh
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Commonwealth Scholarship Commission
First posted: 2024-05-06
Enrollment: 1280
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial will have two groups: intervention and control. The unit of randomisation will be schools, where the adolescents enrolled in school years 8 and 9 in Dhaka, Bangladesh.
Primary purpose: PREVENTION

Brief summary: This school-based cluster randomized controlled trial aims to assess the feasibility of implementing the Adolescent Tobacco Initiation Prevention (IATIP) and evaluate the potential efficacy of IATIP in preventing tobacco initiation and promoting the health and well-being of school adolescents in Dhaka, Bangladesh. 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.

Detailed description: Background and Aims: Adolescent tobacco use is a significant public health challenge, particularly in low- and middle-income countries like Bangladesh. An Intervention for Adolescent Tobacco Initiation Prevention (IATIP) has been developed to address this issue. This study aims to assess the feasibility of implementing the IATIP and evaluate its potential efficacy in preventing tobacco initiation and promoting health and well-being.

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.

Eligibility criteria: Inclusion Criteria:

* Bangladeshi school adolescent
* Students at one of the participating schools
* Students of Years 8 and 9

Exclusion Criteria:

* Students of physical and mental impairment
* don't understand and read the 'Bangla' language
* don't have parental consent

Primary outcomes:
measure: Feasibility of the intervention: recruitment rate
timeFrame: Before starting the intervention, an average of 10 days.
measure: Feasibility of the intervention: attrition rate
timeFrame: Through study completion, an average of 2 months.
measure: Feasibility of the intervention: fidelity of delivery
timeFrame: Immediately after the completion of the intervention delivery, an average of 30 days.
measure: Feasibility of the intervention: acceptability
timeFrame: Immediately after the completion of the intervention delivery, an average of 30 days.
Secondary outcomes:
measure: Change in the intention to initiate tobacco use
timeFrame: Up to 5 weeks
measure: Change in self-rated physical health score
timeFrame: Up to 5 weeks
measure: Evaluate the promotion of overall mental well-being
timeFrame: Up to 5 weeks
measure: Change in stress score
timeFrame: Up to 5 weeks
measure: Change in anxiety score
timeFrame: Up to 5 weeks
measure: Change in depression score
timeFrame: Up to 5 weeks
measure: Change in knowledge
timeFrame: Up to 5 weeks
measure: Change in attitudes
timeFrame: Up to 5 weeks
measure: Change in beliefs
timeFrame: Up to 5 weeks
measure: Skill development: Decision-making
timeFrame: Up to 5 weeks
measure: Skill development: Refusal skill
timeFrame: Up to 5 weeks
measure: Skill development: Self-esteem
timeFrame: Up to 5 weeks
measure: Skill development: Problem solving
timeFrame: Up to 5 weeks
measure: Skill development: Assertiveness
timeFrame: Up to 5 weeks
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Secondary schools
Study officials:
affiliation: University College, London
name: Sahadat Hossain, MSPH
role: PRINCIPAL_INVESTIGATOR
References: