A trial to assess the effectiveness and cost-effectiveness of a school-based Smoke-Free Intervention in reducing children's exposure to second-hand smoke

ISRCTN	ISRCTN28878365
DOI	https://doi.org/10.1186/ISRCTN28878365
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Version 1.3, 20th February 2020
Sponsor	University of York
Funders	Wellcome Trust, Medical Research Council, National Institute for Health Research

Submission date: 30/04/2020
Registration date: 13/05/2020
Last edited: 18/06/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Breathing in other people's smoke is called second-hand smoking (SHS). SHS is harmful to children's health and leads to chest and ear infections, tuberculosis, meningitis and asthma. It also causes lung cancer and heart disease. Globally, 40% of children are exposed to SHS. Many countries have introduced bans on smoking in enclosed public spaces, but for the majority of children, cars and homes remain the most likely places for them to breathe in SHS. The only possible way to protect children from SHS is to make cars and homes completely smoke-free. The researchers have conducted a pilot study involving children, teachers and parents in schools in Bangladesh to develop and test a school-based intervention called ‘Smoke-Free Intervention’ (SFI). Their work has shown promising results showing that SFI can encourage children to negotiate smoking restrictions inside their homes. They have also conducted a feasibility study in Pakistan where SFI was culturally adapted and was found acceptable to be delivered in school. The aim of this study is to examine how effective SFI is at preventing respiratory and other smoking-related illnesses in Bangladesh and Pakistan by reducing children's exposure to SHS. Pakistan is included because of its comparable disease burden to Bangladesh.

Who can participate?
Children studying in year 5 (9 to 12 years old) at participating schools

What does the study involve?
The researchers are proposing to conduct this study in Dhaka, Bangladesh and Karachi, Pakistan. They will recruit a total of 74 primary schools, 34 from Bangladesh and 40 from Pakistan. They will conduct measurements including testing children's saliva for cotinine, a chemical detected in those exposed to SHS. Other measures will include questionnaires and diaries to be kept by children to record their chest symptoms and scales to measure school performance and attitudes to smoking. Once measurements have been taken, half of the schools will be randomly chosen to receive SFI while the other half will not receive the intervention until the end. The Smoke-Free Intervention (SFI) comprises six interactive lessons delivered by school teachers including five fun activities and one take-home educational resources. Taught lessons increase pupils' knowledge about the associated harms of SHS. Fun activities including storytelling, role-playing, quizzes and games, motivate children to act and feel confident in persuading adults to take seven steps away from the house to smoke. The take-home resource also helps children to negotiate with their families to "sign-up" to a voluntary contract to make their homes smoke-free. The researchers will repeat the assessments at 3, 6 and 12 months after the intervention.

What are the possible benefits and risks of participating?
Some of the concerns are as follows. Children’s participation raises issues around competence, vulnerability and powerlessness. In this study, children’s wishes and their welfare will take precedence over the research requirements. Research burden will be kept to a minimum. Children and their families will not be reimbursed financially, however, small incentives in the form of school stationery will be offered. Based on the feasibility work, it is highly unlikely that the children will face any adverse reaction from their families. Obtaining saliva is also not harmful to children, neither it could disclose the presence of any medical condition. All participants’ data will be kept confidential and in password-protected servers. The risks associated with this study are minimal, and it is unlikely that the questionnaires or interviews will lead to any potential legal, social, or psychological problems. The process of collecting saliva samples is also easy and safe. Each participant will place a cotton dental roll inside the cheek for 2 minutes to collect saliva. Soaked cotton rolls will be placed in a plastic container. Study personnel will provide detailed instructions to the participants for the saliva sample. The participant will be entitled to withdraw at any time of the research process even after s/he initially agreed to participate.

Where is the study run from?
The study will be centrally coordinated from The University of York (UK). In each country it will be run from Aga Khan University (Pakistan) and the ARK Foundation (Bangladesh).

When is the study starting and how long is it expected to run for?
December 2019 to June 2024

Who is funding the study?
1. Medical Research Council (MRC) (UK)
2. Wellcome Trust (UK)
3. National Institute of Health Research (NIHR) (UK)

Who is the main contact?
Prof. Kamran Siddiqi
kamran.siddiqi@york.ac.uk

Contact information

Prof Kamran Siddiqi
Public

Department of Health Sciences
Seebohm Rowntree Building
The University of York
Heslington
York
YO10 5DD
United Kingdom

Phone	+44 (0)7970 544872
Email	kamran.siddiqi@york.ac.uk

Prof Kamran Siddiqi
Scientific

Department of Health Sciences
Seebohm Rowntree Building
The University of York
Heslington
York
YO10 5DD
United Kingdom

Phone	+44 (0)7970 544872
Email	kamran.siddiqi@york.ac.uk

Dr Rumana Huque
Scientific

ARK Foundation
Flat C3 & C4, House No. 6
Road No. 109, Gulshan 2
Dhaka
1212
Bangladesh

ORCID ID	0000-0002-7616-9596
Phone	+880 (0)255069866
Email	rumanah14@yahoo.com

Study information

Primary study design	Interventional
Study design	Multi-centre cluster randomized controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Children Learning About Second-hand Smoking (CLASS III): a cluster randomised controlled trial
Study acronym	CLASS III
Study objectives	The aim of this study is to examine how effective SFI is at preventing respiratory and other smoking-related illnesses in Bangladesh and Pakistan by reducing children's exposure to SHS.
Ethics approval(s)	Approved 16/04/2020, Health Sciences Research Governance Committee (HSRGC) at The University of York (Department Of Health Sciences, York, YO10 5DD, UK; +44 (0)1904 323253; smh12@york.ac.uk), no ref number
Health condition(s) or problem(s) studied	Prevention of respiratory illnesses in children
Intervention	1. Smoke Free Intervention (SFI): The proposed trial (CLASS III) is the natural sequence, which follows the encouraging findings of the above studies and uses the MRC Framework for Developing and Evaluating Complex Interventions. All participating children in the intervention arm will receive the SFI delivered by their teachers. Teachers will receive prior training in delivering the intervention. Their training will focus on their knowledge gaps around tobacco, their skills in using various teaching methods and their ability to build confidence within and teach negotiation skills to children. The intervention will consist of: Two 45-minute sessions delivered over two days by schoolteachers. The duration of these sessions is consistent with regular school lessons. These sessions will consist of a flip chart presentation and a full drama activity. These activities are especially designed to increase pupil’s knowledge about SHS and related harms, and motivate them to follow one main step (7 steps away from home) to make their home smoke free. The seven acts of the drama will give children the opportunity to practice their negotiating skills and be confident within their cultural context.It will also serve as a visual incentive for the parents not to smoke inside homes. A set of four follow-up sessions (15 minutes each) to reinforce key messages delivered in the initial sessions, to be delivered once a week over 6-7 weeks after the two initial sessions. The immediate first follow up session will be based on the feedback from parents about the drama activity. The second session will consist of a word search game followed by a discussion in order to enhance pupils’ knowledge about SHS. The third follow up session will comprise a quiz game in which children will be asked questions and given answer options. This will be followed by a discussion as a means of reinforcement. The final follow up session will be based on small group discussions among the students about their experiences and if they faced any challenges. Children are given an achievement certificate to mark the seven achievements to make their homes smoke free. Children are also given a promise form that describes the main step to achieve a smoke-free home i.e to take seven steps away from the house to smoke. It also contains a tear-off slip to make a commitment to impose smoking restrictions at home. Children take promise forms to their parents, show them the messages, and negotiate with them to “sign-up” to the Smoke-Free Homes “promise” form. One of the implications is that even if parents are non-smokers, they will not allow other smokers (residents and visitors) to smoke inside homes. In addition to delivering the intervention, teachers will also be trained to support children in this process. 2. Treatment as usual: Schools in the control arm will receive the intervention at the completion of the trial.
Intervention type	Behavioural
Primary outcome measure(s)	Exposure to second-hand smoking measured by checking salivary cotinine level at baseline and month 3
Key secondary outcome measure(s)	Current secondary outcome measures as of 07/06/2022: 1. Frequency and severity of respiratory symptoms recorded by asking children to keep a diary for 16 respiratory symptoms and record their severity on a validated four-point Likert scale for a whole month (4 weeks) in three follow up periods i.e. 3rd, 6th and 12th month. For each item, ‘0’ represents the absence of a symptom, 1 represents mild, 2 represents moderate and 3 represents the greatest severity level 2. Smoking-related behaviour recorded by asking the children to self-report levels of smoking restrictions and social visibility of smoking at home through a questionnaire at baseline, and months 3, 6 and 12 3. Health service use recorded by using a health service utilisation questionnaire at baseline, and months 3, 6 and 12 4. Quality of life assessed using the EQ-5D-Y questionnaire at baseline, and months 3, 6 and 12 5. Absenteeism and academic performance measured by each participating school providing a report on the academic performance of participating children using the Academic Performance Questionnaire (APQ) measures at baseline and months 3, 6 and 12 Previous secondary outcome measures as of 13/04/2021: 1. Frequency and severity of respiratory symptoms recorded by asking children to keep a diary for 13 respiratory symptoms and record their severity on a validated four-point Likert scale for a whole month (4 weeks) in three follow up periods i.e. 3rd, 6th and 12th month. For each item, ‘0’ represents the absence of a symptom, 1 represents mild, 2 represents moderate and 3 represents the greatest severity level 2. Smoking-related behaviour recorded by asking the children to self-report levels of smoking restrictions and social visibility of smoking at home through a questionnaire at baseline, and months 3, 6 and 12 3. Health service use recorded by using a health service utilisation questionnaire at baseline, and months 3, 6 and 12 4. Quality of life assessed using the EQ-5D-Y questionnaire at baseline, and months 3, 6 and 12 5. Absenteeism and academic performance measured by each participating school providing a report on the academic performance of participating children using the Academic Performance Questionnaire (APQ) measures at baseline and months 3, 6 and 12 Previous secondary outcome measures: 1. Frequency and severity of respiratory symptoms recorded by asking children to keep a diary for 13 respiratory symptoms and record their severity on a validated four-point Likert scale for a whole month (4 weeks) in three follow up periods i.e. 3rd, 6th and 12th month. For each item, ‘0’ represents the absence of a symptom, 1 represents mild, 2 represents moderate and 3 represents the greatest severity level 2. Smoking-related behaviour recorded by asking the children to self-report levels of smoking restrictions and social visibility of smoking at home through a questionnaire at baseline, and months 3, 6 and 12 3. Health service use recorded by using a health service utilisation questionnaire at baseline, and months 3, 6 and 12 4. Quality of life assessed using the CHU-9D questionnaire at baseline, and months 3, 6 and 12 5. Absenteeism and academic performance measured by each participating school providing a report on the academic performance of participating children using the Academic Performance Questionnaire (APQ) measures at baseline and months 3, 6 and 12
Completion date	30/06/2024

Eligibility

Participant type(s)	Learner/student
Age group	Child
Lower age limit	9 Years
Upper age limit	12 Years
Sex	All
Target sample size at registration	2720
Total final enrolment	2752
Key inclusion criteria	1. Studying in year 5 in the participating school and their age range is between 9 and 12 years 2. Self-reported non-tobacco users (i.e. smoked or smokeless)
Key exclusion criteria	1. Serious medical condition which is either life-threatening or requires regular hospitalisation 2. History of domestic violence and abuse (in any form)
Date of first enrolment	02/05/2022
Date of final enrolment	30/11/2022

Locations

Countries of recruitment

Bangladesh
Pakistan

Study participating centres

ARK Foundation

Dhaka
Dhaka 1212
Bangladesh

Aga Khan University

74800
Pakistan

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Kamran Siddiqi (kamran.siddiqi@york.ac.uk).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		14/07/2023	17/07/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version V1.3.1		18/05/2020	No	No
Protocol file	version 1.4.1	30/05/2020	07/06/2022	No	No
Statistical Analysis Plan	version 1.0	20/04/2023	28/04/2023	No	No

Additional files

ISRCTN28878365_PROTOCOL_V1.3.1.docx: uploaded 18/05/2020
ISRCTN28878365 PROTOCOL V1.4.1 30May2020.pdf: Protocol file
ISRCTN28878365_SAP_v1.0_20April2023.pdf: Statistical Analysis Plan

Editorial Notes

18/06/2024: The intention to publish date was changed from 30/10/2024 to 28/02/2025
12/02/2024: The plain English summary was updated.
25/01/2024: Study contacts updated.
09/01/2024: The following changes have been made to the trial record:
1. The overall study end date was changed from 15/01/2024 to 30/06/2024.
2. The intention to publish date was changed from 07/03/2024 to 30/10/2024.
17/07/2023: Publication reference added.
16/11/2022: The following changes were made to the trial record:
1. The target number of participants has been changed from "Number of clusters: 68 (34 from each site), participants in each cluster: 1360" to "Number of clusters: 68 (34 from each site); participants per site (total two sites): 1360".
2. The total target enrolment has been changed from 92480 to 2720.
3. The total final enrolment has been added.
17/10/2022: The recruitment end date has been changed from 31/10/2022 to 30/11/2022.
07/06/2022: The following changes were made to the trial record:
1. Uploaded protocol v1.4.1 (not peer-reviewed) as an additional file.
2. The secondary outcome measures were changed.
3. The overall end date was changed from 07/07/2023 to 15/01/2024.
4. The recruitment end date was changed from 01/08/2022 to 31/10/2022.
5. The plain English summary was updated to reflect these changes.
11/02/2022: The recruitment start date was changed from 02/02/2022 to 02/05/2022.
11/08/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/08/2021 to 02/02/2022.
2. The recruitment end date has been changed from 01/11/2021 to 01/08/2022.
13/04/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/04/2021 to 01/08/2021.
2. The recruitment end date was changed from 29/07/2021 to 01/11/2021.
08/02/2021: The recruitment start date was changed from 01/02/2021 to 01/04/2021.
05/10/2020: The recruitment start date has been changed from 01/10/2020 to 01/02/2021.
04/08/2020: The recruitment start date was changed from 17/08/2020 to 01/10/2020.
18/05/2020: Uploaded protocol (not peer reviewed) as an additional file.
11/05/2020: Trial's existence confirmed by Health Sciences Research Governance Committee (HSRGC) at The University of York.