Health BehaviourIATIPNCT06399588
Intervention for Adolescent Tobacco Initiation Prevention
A study testing Intervention for Adolescent Tobacco Initiation Prevention (IATIP) in people with Health Behaviour and Tobacco Prevention, run by University College, London at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behaviour, Tobacco Prevention, Well-being
- What is being tested?
- Intervention for Adolescent Tobacco Initiation Prevention (IATIP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,280 participants
- Where
- 1 siteBangladesh
- Study dates
- 2 May 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Bangladeshi school adolescent
- Students at one of the participating schools
- Students of Years 8 and 9
Who cannot join
- Students of physical and mental impairment
- don't understand and read the 'Bangla' language
- don't have parental consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Health Behaviour, Tobacco Prevention, Well-being
- Being tested
- Intervention for Adolescent Tobacco Initiation Prevention (IATIP)
- Keywords
- Adolescent, Tobacco initiation, Health and Well-being, Prevention, School-based intervention, C-RCT, Bangladesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention for Adolescent Tobacco Initiation Prevention (IATIP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after the completion of the intervention delivery, an average of 30 days.
Secondary outcomes (14)
Change in the intention to initiate tobacco use
To assess this, a two-item Likert scale will be used: (1) "if someone (cousin/friend/close relative) offers you a tobacco product, would you use it?" and (2) "at any time during the next 12 months, do you think you will use any form of tobacco?". Responses to these questions will be categorized into four options: "Definitely not," "Probably not," "Probably yes," and "Definitely yes." This scale produces a potential range of 0-6, with lower scores indicating a lower likelihood of intending to initiate tobacco use within the next 12 months. The potential effect of the intervention will be determined by changes in scores between baseline and follow-up.
Measured: Up to 5 weeks
Change in self-rated physical health score
To assess self-rated physical health status, participants will be asked to rate their overall physical health conditions with five response options: 1 = very poor, 2 = poor, 3 =moderate, 4 = good and 5 = very good. The response options will be treated as a continuous ordinal measure. Therefore, a higher score indicates a better health condition. The potential effect of the intervention will be determined by changes in scores between baseline and follow-up.
Measured: Up to 5 weeks
Evaluate the promotion of overall mental well-being
The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) will be used to measure participants' overall mental well-being. This validated 7-item 5-point Likert scale scores range from 7 to 35 and higher scores indicate higher positive mental wellbeing. The potential effect of the intervention will be determined by changes in scores between baseline and follow-up.
Measured: Up to 5 weeks
Change in stress score
To assess the participants' level of stress, the 10-item Perceived Stress Scale (PSS) will be used. This widely recognized scale assesses the extent to which individuals perceive situations in their lives as stressful. Responses will be collected on a 5-point Likert scale, with 0 indicating 'never,' 1 = almost never, 2 = sometimes, 3 = fairly often, and 4 indicating 'very often.' A total score for each adolescent will be obtained by summing the scores across all 10 items for a total range of 0 to 40. A higher score indicates higher perceived stress. The potential effect of the intervention will be determined by changes in scores between baseline and follow-up.
Measured: Up to 5 weeks
Change in anxiety score
One of the most popularly used 7-item scales, the Generalized Anxiety Disorder-7 (GAD-7) will be used to identify participant's anxiety in this trial. Participants will be asked how often they were bothered by each of the seven core symptoms of GAD with four response options: 0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day, over the last 14 days. The response options will also be calculated as a continuous ordinal measure. Therefore, the range of scores of the GAD-7 will be 0 to 21. A higher score indicates a higher level of anxiety. The potential effect of the intervention will be determined by changes in scores between baseline and follow-up.
Measured: Up to 5 weeks
Change in depression score
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess the level of depression. Participants will be asked how often they were bothered by each of the nine core symptoms of PHQ-9 with four response options: 0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day, over the last 14 days. The response options will also be calculated as a continuous ordinal measure. Therefore, the range of scores of the GAD-7 will be 0 to 27. A higher score indicates a higher level of depression. The potential effect of the intervention will be determined by changes in scores between baseline and follow-up.
Measured: Up to 5 weeks
Change in knowledge
To assess participant's knowledge about tobacco and health, a set of 20 items will be used. A participant will earn 1 point for each correct response, while an incorrect or unknown answer will be scored as 0 points. The cumulative knowledge score will be calculated by summing the points from all items, with a maximum achievable score of 20 points. A higher score indicates a more knowledgeable individual. The potential effect of the intervention will be determined by changes in scores between baseline and follow-up.
Measured: Up to 5 weeks
Change in attitudes
To measure participants' attitudes toward tobacco and health, a 16-item standardized scale will be utilised. Each item is structured as a Likert-type scale with five ranks. A quantitative approach will be employed to summarize the responses across all attitude items. For positive attitude items, responses of ''extremely agree'' will be scored as 5 points, ''agree'' as 4 points, ''unclear'' as 3 points, ''disagree'' as 2 points, and ''extremely disagree'' as 1 point. Conversely, for negative attitude items, the scoring will be reversed as 1, 2, 3, 4, and 5 points. The total attitude scale score will be the sum of all item scores, with a maximum attainable score of 80 points and a minimum of 16 points. A higher score indicates a more negative attitude toward tobacco.
Measured: Up to 5 weeks
Change in beliefs
To assess participants' beliefs about tobacco use, an 8-item scale will be used. This scale focuses on both positive (4 items) and negative (4 items) beliefs concerning various aspects of tobacco use. Participants will be asked to rate the likelihood of each scenario happening to them if they use tobacco in the next month. Responses will be collected on a 4-point Likert-type scale: 1=very likely, 2=likely, 3=unlikely, 4=very unlikely. Positive beliefs (score 8 to 32) include feeling relaxed, having fun, being popular, and being confident and outgoing. Negative beliefs (score 8 to 32) encompass issues with parents and friends, financial problems, and the risk of addiction. A lower score indicates more positive or negative beliefs about tobacco.
Measured: Up to 5 weeks
Skill development: Decision-making
For 'Decision-Making Skills,' Participants will respond to statements reflecting different approaches to decision-making, indicating their level of agreement (1=Strongly Agree, 2=Agree, 3=Disagree, 4=Strongly Disagree) across five items. Differences in item responses between baseline and follow-up will be assessed to evaluate the effect of the intervention.
Measured: Up to 5 weeks
Skill development: Refusal skill
For 'Refusal Skills,' participants will navigate hypothetical situations, expressing their likelihood of refusal (1=Very Likely, 2=Likely, 3=Unlikely, 4=Very Unlikely) in response to three scenarios. Differences in item responses between baseline and follow-up will be assessed to evaluate the effect of the intervention.
Measured: Up to 5 weeks
Skill development: Self-esteem
'Self-esteem' will be assessed through agreement with self-descriptive statements (1=Strongly Agree, 2=Agree, 3=Disagree, 4=Strongly Disagree), encompassing ten items. Differences in item responses between baseline and follow-up will be assessed to evaluate the effect of the intervention.
Measured: Up to 5 weeks
Skill development: Problem solving
'Problem-Solving Skills' will be assessed by responses to statements related to interpersonal dealings (1=Strongly Agree, 2=Agree, 3=Disagree, 4=Strongly Disagree), consisting of five items. Differences in item responses between baseline and follow-up will be assessed to evaluate the effect of the intervention.
Measured: Up to 5 weeks
Skill development: Assertiveness
'Assertiveness' will be evaluated by considering the ease or difficulty participants perceived in accomplishing certain tasks (1=Very Easy, 2=Easy, 3=Difficult, 4=Very Difficult) across six scenarios. Differences in item responses between baseline and follow-up will be assessed to evaluate the effect of the intervention.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start2 May 2024 (estimated)
- Primary completion20 Jul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviourStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Commonwealth Scholarship Commission
- Responsible party
- Principal investigator, Sahadat Hossain, University College, London
- Investigators
- Sahadat Hossain, MSPH, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399588
- Sponsor's protocol ID
- 22645/004
- Acronym
- IATIP
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not release any identifiable data of the participants to any third parties, in accordance with our ethical obligations. However, the overall anonymized dataset will be made available upon request, solely for research purposes.
Publications
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.
PubMed 41250156
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06399588
- Acronym / sponsor ID
- IATIP / 22645/004
- Conditions
- Health Behaviour, Tobacco Prevention, Well-being
- Keywords
- Adolescent, Tobacco initiation, Health and Well-being, Prevention, School-based intervention, C-RCT, Bangladesh
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,280 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Commonwealth Scholarship Commission
- Study start
- 2 May 2024 (estimated)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention for Adolescent Tobacco Initiation Prevention (IATIP)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. |
| 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. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Bangladeshi school adolescent
- Students at one of the participating schools
- Students of Years 8 and 9
Key exclusion criteria (3 listed)
- Students of physical and mental impairment
- don't understand and read the 'Bangla' language
- don't have parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group |
Primary outcome
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: 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: 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: 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.
14 secondary outcomes
Change in the intention to initiate tobacco use
Time frame: Up to 5 weeks
Change in self-rated physical health score
Time frame: Up to 5 weeks
Evaluate the promotion of overall mental well-being
Time frame: Up to 5 weeks
Change in stress score
Time frame: Up to 5 weeks
Change in anxiety score
Time frame: Up to 5 weeks
Change in depression score
Time frame: Up to 5 weeks
Change in knowledge
Time frame: Up to 5 weeks
Change in attitudes
Time frame: Up to 5 weeks
Change in beliefs
Time frame: Up to 5 weeks
Skill development: Decision-making
Time frame: Up to 5 weeks
Skill development: Refusal skill
Time frame: Up to 5 weeks
Skill development: Self-esteem
Time frame: Up to 5 weeks
Skill development: Problem solving
Time frame: Up to 5 weeks
Skill development: Assertiveness
Time frame: Up to 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Derived from this study: PubMed 41250156Hossain 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.
- Individual participant dataSharing planned: No. We will not release any identifiable data of the participants to any third parties, in accordance with our ethical obligations. However, the overall anonymized dataset will be made available upon request, solely for research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahadat Hossain, MSPH principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention for Adolescent Tobacco Initiation Prevention (IATIP) in people with Health Behaviour and Tobacco Prevention, run by University College, London at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sahadat Hossain, MSPH (+447448006075, sahadat.hossain.21@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention: recruitment rate (time frame: Before starting the intervention, an average of 10 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06399588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.