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

Children Learning About Second-hand Smoking (CLASS III): a cluster randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN28878365

Enrollment

2720

Registered

2020-05-13

Start date

2022-05-02

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Prevention of respiratory illnesses in children Respiratory

Interventions

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 Eval

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Exposure to second-hand smoking measured by checking salivary cotinine level at baseline and month 3	—

Secondary

Measure	Time frame
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 base	—

Measure

Time frame

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 base

—

Countries

Bangladesh, Pakistan

Contacts

Public ContactKamran Siddiqi

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026