Children learning about second-hand smoke (CLASS II)

• Register: ISRCTN
• Last refreshed on: 7 June 2021
• Main ID: ISRCTN68690577
• Date of registration: 05/05/2015
• Prospective Registration: No
• Primary sponsor: University of York
• Public title: Children learning about second-hand smoke (CLASS II)
• Scientific title: Children Learning About Second-hand Smoke (CLASS II): a pilot cluster randomised controlled trial
• Date of first enrolment: 30/04/2015
• Target sample size: 360
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN68690577
• Study type: Interventional
• Study design: Pilot cluster randomised controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Bangladesh

Contacts

• Name: Rumana Huque

Key inclusion & exclusion criteria

Inclusion criteria:
1. Eligible schools (public and private) are following mainstream curricula approved by the educational authorities
2. Eligible schools have year-five classes, with >40 and <120 year-five children (10-12 years old) per class.
3. Eligible schools have a ‘no-smoking’ policy and all participating year-five teachers are self-reported non-smokers
4. Eligible students aged 10-12 in year five attending participating schools
5. Eligible students have parental consent to participate
6. Eligible students are non-smokers

Exclusion criteria:
Children are excluded if they have any of the following conditions/situations that the school is aware of:
1. Physical or mental disabilities
2. Learning difficulties and/or special learning-needs
3. Behavioural problems and/or conduct disorder
4. Serious medical condition which is either life threatening or requires regular hospitalisation
5. History of domestic violence and abuse (in any form)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Smoke Free Intervention (SFI) education programme.
Not Applicable

Intervention(s)

1. Schoolteachers are trained to deliver Smoke Free Intervention (SFI) education to children in their class. All participating children in the intervention group will have SFI delivered by their teachers.
2. Schoolteachers give two 45-minute SFI session to children over two days. Each session consists of a range of educational activities including classroom presentations, quiz, interactive games, storytelling and role-play - vicarious learning techniques are utilised in many of these activities. The presentation, quiz and games are designed to increase pupils’ knowledge about SHS and related harms, and motivate them to follow three easy steps to make their homes smoke-free. The storybook and role-play focuses on enhancing children’s negotiation skills, building their confidence within Bangladeshi cultural context. While the storybook depicts challenges of negotiating with elders, the role-play has hypothetical scenarios where children had opportunity to practice and demonstrate how and when they can discuss and negotiate with elders to persuade them not to smoke inside homes.
2. A set of four refresher SFI sessions (15 minutes each) are given to children by schoolteachers to reinforce the key messages delivered in the initial sessions. Refresher session are delivered once a week, 6-7 weeks after the first two sessions. During the refreshers, the teacher reminds children of the key points of the main session by asking questions (5 to 7 minutes), and then encouraging students to share their experiences of whether they could initiate discussion at home, what challenges did they face, what is their plan to do next and what would be the best way to convince the elders (8 to 10 minutes). The length of these sessions is consiste

Primary Outcome(s)

Children’s exposure to SHS is measured by testing their salivary cotinine levels using a sterile swab. Salivary cotinine concentration is strongly associated with the exposure to SHS at home. Saliva samples will be obtained from all participating children at baseline and also two-months post intervention.

Secondary Outcome(s)

1. Frequency and severity of respiratory symptoms: participating children will be given diaries to record respiratory symptoms on a nominal severity scale from 0 to 3. Children will record their symptoms using facial expressions stickers to show how they feel. These diaries will have three sections. Section 1 will record symptoms from the day intervention is delivered till the end of month-two. Section 2 from the start of month-three till the end of month-six and section 3 from the start of month-seven till the end of month-twelve. At each follow up, one section will be taken out of the diary by the researchers and data will be entered in the database. All children will provide data on section 1. However, only those children will provide data on section 2 and 3 whose cotinine levels are indicative of passive smoking at the baseline. Children will be told whether to stop or keep collecting information in their diaries in a letter. The assessments will be carried out at both baseline and follow ups.
2. Lung Functions: we will measure lung functions on all participating children at the baseline and on children with positive salivary cotinine at month-two, six and twelve. For this we will use a spirometer as per British Thoracic Society guidelines. This would involve measuring forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), peak expiratory flow (PEF), and maximal mean expiratory flow (MMEF). We will first record, height and body weight of all participating children at the baseline. We will enter details of the patient’s sex, race, age and height into the spirometer. We will then ask each child to blow into a disposable mouthpiece attached to the spirometer at least three times as per guidelines. Best of the three readings will be taken. The spirometer will also calculate the percentage of the predicted normal values as they have the reference data already programmed into them. The spirometer will print out a lung function test report for each participant, which will be attached to the participant baseline or follow up questionnaire, respectively. Spirometer will be cleaned according to the manufacturer’s guidelines and its accuracy will be checked regularly. The assessments will be carried out at both baseline and follow ups.
3. Smoking related behaviours: we will ask the children to self-report levels of smoking restrictions and social visibility of smoking at home using a questionnaire. Using the same questionnaire, we will also assess children’s self-reported attitude towards smoking and intention to start smoking. We will use a five-point smoking uptake scale19 to categorise children as non-susceptible non-smokers, susceptible non-smokers, early experimenters, advanced experimenters and established smokers. The assessments will be carried out at both baseline and follow ups.
4. Health service use: we will use a health service utilisation questionnaire previously used in the MCLASS trial, to collect number and type of contacts with doctors, hospital admissions, pharmacy visits and antibiotic prescriptions. This information will be part of the baseline questionnaire but will also be assessed at all follow-up time points.
5. Quality of Life (QoL): QoL (generic) will be assessed by using a short QoL questionnaire for children, PedsQoL. The questions will be included in the baseline and follow up questionnaires.
6. Other confounding variables: at baseline, we will also ask children to report on some of the basic socio-demographic details on the questionnaire. These will include age, gender, household amenities, family structure, co-habiting smokers – including parents, pet ownership, overcrowding - number of rooms and residents, built environment, neighbourhood, presence of mould/moisture in the child’s home, and use of gas for cooking or gas/kerosene/oil heater. Furthermore, we will include information on children’s medical history (particularly asthma and chest infections) and use of any regular medications.
7. Absenteeism and academic performance: each participating school will be asked to provide a report on the academic performance of participating children using the Academic Performance Questionnaire (APQ), a 10-item questionnaire to be completed by teachers. Using 4- and 5-point ordinal scales, it measures child’s performance in reading, mathematics, writing, and homework. This questionnaire will be completed at the baseline and at all follow-ups. In addition, schools will also be requested to provide a record of child’s absenteeism from school including number of days missed every month in between two assessments.
8. Fidelity Index: the research team will use a fidelity index, mapped onto the behaviour change techniques that underpin SFI, to assess intervention adherence. This will be in the form of a check list, which will used to monitor the delivery of SFI sessions. One of the members of the research team will attend all SFI sessions and using the above check list will score fidelity to SFI.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Medical Research Council

Ethics review

Status:
Approval date:
Contact:

1. Bangladesh Medical Research Council (BMRC), Bangladesh 2. University of York Ethics Committee, 16/03/2015.

Results

• Results available: Yes
• Date Completed: 31/03/2017