Intervention for Adolescent Tobacco Initiation Prevention

NCT06399588 | Not Yet Recruiting DMC

• 1 other identifier: 22645/004
• Study Type: interventional
• Target: 1,280
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behaviour; Tobacco Prevention; Well-being

Keywords

Adolescent; Tobacco initiation; Health and Well-being; Prevention; School-based intervention; C-RCT; Bangladesh

Outcome Measures

Primary Outcomes (4)

• Feasibility of the intervention: recruitment rate

  The percentage of eligible participants who agree to take part in the study will be calculated to evaluate recruitment rate.

  Before starting the intervention, an average of 10 days.

• Feasibility of the intervention: attrition rate

  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.

  Through study completion, an average of 2 months.

• Feasibility of the intervention: fidelity of delivery

  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.

  Immediately after the completion of the intervention delivery, an average of 30 days.

• Feasibility of the intervention: acceptability

  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.

  Immediately after the completion of the intervention delivery, an average of 30 days.

Secondary Outcomes (14)

• Change in the intention to initiate tobacco use

  Up to 5 weeks

• Change in self-rated physical health score

  Up to 5 weeks

• Evaluate the promotion of overall mental well-being

  Up to 5 weeks

• Change in stress score

  Up to 5 weeks

• Change in anxiety score

  Up to 5 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Intervention for Adolescent Tobacco Initiation Prevention (IATIP)

Control group

NO INTERVENTION

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.

Interventions

Intervention for Adolescent Tobacco Initiation Prevention (IATIP) BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead
• Commonwealth Scholarship Commission: collaborator

Study Sites (1)

Secondary schools

Dhaka, Bangladesh

Location

Related Publications (1)

• Hossain S, Beard E, Shahab L. Intervention for adolescent tobacco initiation prevention (IATIP) to promote health and well-being: a protocol for a pilot cluster randomised controlled trial in Dhaka, Bangladesh. Pilot Feasibility Stud. 2025 Nov 17;11(1):145. doi: 10.1186/s40814-025-01710-9.

  PMID: 41250156 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sahadat Hossain, MSPH

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sahadat Hossain, MSPH

CONTACT

+447448006075; sahadat.hossain.21@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 6, 2024
• Study Start: May 2, 2024
• Primary Completion: July 20, 2024
• Study Completion: December 1, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)