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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University College, London
- Enrollment
- 1,280
- Locations
- 1
- Primary Endpoint
- Feasibility of the intervention: fidelity of delivery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 11 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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: Intervention for Adolescent Tobacco Initiation Prevention (IATIP) (Behavioral)
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.
Outcomes
Primary Outcomes
Feasibility of the intervention: fidelity of delivery
Time Frame: Immediately after the completion of the intervention delivery, an average of 30 days.
The fidelity of intervention delivery will be assessed using a pre-defined index, consisting of 21 content items. A 3-point Likert (0 = not implemented, 1 = partially implemented and 2 = fully implemented) will be used to assess the fidelity index. A higher score indicates a more fidelity of intervention delivery.
Feasibility of the intervention: attrition rate
Time Frame: Through study completion, an average of 2 months.
The dropout rate will be monitored as a measure of attrition, specifically, calculating the percentage of recruited participants who do not complete the follow-up assessment.
Feasibility of the intervention: recruitment rate
Time Frame: Before starting the intervention, an average of 10 days.
The percentage of eligible participants who agree to take part in the study will be calculated to evaluate recruitment rate.
Feasibility of the intervention: acceptability
Time Frame: Immediately after the completion of the intervention delivery, an average of 30 days.
To evaluate the acceptability of the intervention, participants' perceptions of the intervention's relevance, and appropriateness will be explored. Participants will be asked a 5-point Likert scale question: "To what extent do you feel the study sessions met your expectations?", with response options ranging from 1 (not at all) to 5 (completely). They will also be asked, "To what extent do you think the components were relevant to preventing tobacco initiation and promoting health and well-being?" and "To what extent do you think the images and videos presented in the sessions were appropriate and relevant to the contents?" with the same measures. The clarity and comprehensibility of the intervention materials, such as handbooks and presentations, will be rated on a 5-point Likert scale from 1 (not at all) to 5 (extremely). A higher score indicates a more acceptable intervention.
Secondary Outcomes
- Skill development: Decision-making(Up to 5 weeks)
- Change in the intention to initiate tobacco use(Up to 5 weeks)
- Evaluate the promotion of overall mental well-being(Up to 5 weeks)
- Change in stress score(Up to 5 weeks)
- Skill development: Refusal skill(Up to 5 weeks)
- Skill development: Problem solving(Up to 5 weeks)
- Change in self-rated physical health score(Up to 5 weeks)
- Change in anxiety score(Up to 5 weeks)
- Change in knowledge(Up to 5 weeks)
- Skill development: Assertiveness(Up to 5 weeks)
- Change in depression score(Up to 5 weeks)
- Change in attitudes(Up to 5 weeks)
- Change in beliefs(Up to 5 weeks)
- Skill development: Self-esteem(Up to 5 weeks)
Investigators
Sahadat Hossain
Principal Investigator
University College, London