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Children learning about second-hand smoke (CLASS II)

Children Learning About Second-hand Smoke (CLASS II): a pilot cluster randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68690577
Enrollment
360
Registered
2015-05-05
Start date
2015-04-30
Completion date
Unknown
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoke Free Intervention (SFI) education programme. Not Applicable

Interventions

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 teach

Sponsors

University of York
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 functio

Countries

Bangladesh

Contacts

Public ContactRumana Huque

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026