Children's exposure to second-hand smoke Respiratory Second hand smoke
Conditions
Interventions
It is planned that schools in the intervention arm will receive SFH at the beginning of the autumn term 2011 (September 2011) by which time participating children will be in Years 5 and 6.
SFH is a s
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Schools: 1. Primary schools in Yorkshire from neighbourhoods with high deprivation, initially from the lowest 10% super output areas (this could be increased to 20% if required) 2. Schools in neighbourhoods which have above average smoking prevalence rates. The current average is 21%. 3. All secondary schools who have primary schools participating in the CLASS trial in their catchment area, or secondary schools identified by participating primary schools, will be invited to take part in the trial in order that participating children can be followed up. Participants: 1. Within these schools all children (and their parents/carers) in years 4 and 5 in the 2010/2011 school academic year will be eligible for the CLASS trial (children will be aged 8 - 10 years at the time of recruitment). 2. Parents/carers will have to give informed consent for their own participation and their child/childrens participation in the trial 3. After baseline data has been collected only a sample of children and parents/carers will be followed up for the remainder of the trial. This sample will include 90% of children (and their parents/carers) who test positive for cotinine at baseline and 10% of children (and their parents/carers) who test negative for cotinine at baseline.
Exclusion criteria
Exclusion criteria: 1. Primary schools where SFH or any similar activities have taken place in the last two years and where children in Years 4 and 5 in the 2010/2011 school academic year were involved in the activities 2. Primary schools already participating in a similar research study 3. Children and their parents/carers if informed consent cannot be given by the parent/carer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Salivary cotinine levels among participating children (with a detectable level of cotinine at baseline) at first follow up (approximately three months post intervention). We will measure salivary cotinine levels of all children at baseline before the intervention in both arms of the trial. At the first follow up point (3 months), after the intervention, we will measure salivary cotinine levels of children in both arms of the trial, who remain in the trial (90% of children who test positive for cotinine at baseline and 10% of children who test negative for cotinine at baseline). We will look to see if there is a difference in cotinine levels between the intervention and control groups following the intervention. Salivary cotinine measurement is a widely recognised method for detecting both active and passive smoking. The children will be asked to collect saliva in the mouth and blow it into a plastic container through a straw. The samples are subsequently analysed and a gas-liquid chromatography technique can detect cotinine levels as low as 0.1 ng/ml. Based on cotinine measurements taken as part of the national household survey, various thresholds for active and passive smoking have been defined for different age groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of children whose cotinine levels are zero at baseline 2. Smoking restrictions at home assessed through surveys completed by parents/carers at baseline, 1st follow up and through surveys completed by children at baseline and follow up 1 and follow up 3 to 7 3. Children's attitude and behaviours towards smoking and intention to start smoking assessed through surveys completed by children at baseline and follow up 1 and follow up 3 to 7 4. Smoking status of adults and their intention to quit assessed through surveys completed by parents/carers at baseline and follow up 1 5. School attendance, we will collect data on school attendance of participating children from school registers at baseline, during the intervention and at follow up 1 and follow up 3 to 7 6. Children's quality of life measured using a short quality of life questionnaire (PedsQL) completed by children at baseline and follow up 1 and follow up 3 to 7 7. Use of healthcare resources by the families of participating children assessed through Health Service Use surveys completed by parents/carers at baseline, baseline 2, 1st and 2nd follow up 8. Proportion of children whose self reported smoking status and exposure to secondhand smoke is validated by results of salivary cotinine levels at baseline and all follow up points measured by comparing salivary cotinine results with self reported smoking status. Cotinine levels will be assessed in a random sample of children who remain in the trial at all follow points. The size of the random sample will be determined by how well the baseline cotinine tests validate the self reported information provided in the children's baseline surveys. 9. Difference in parent survey response rate (defined as the proportion of surveys returned by participants) when participants are sent electronic reminders on the day they receive the survey 10. Difference in time to parent response (defined as the number of days which elapses, between the survey being sent out to | — |
Countries
United Kingdom
Outcome results
None listed