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Second, we require consent from the students for participation in the trial and a parental opt-out for participation in the trial. This means that parents who are opposed to any forms of mental health promotion are less likely to take part in the trial. However, the expected rates of consent and opt-out for the trials in the two communities suggest that this bias will not be significant. In the two feasibility trials parents were recruited to the trial (10% in the first and 4% in the second [66, 72]) and we expect similar levels of participation in the full trial. The proportion of children who opt-out and are included in the full trial is expected to be similar to that previously achieved in the two feasibility trials.
Participating schools in the full trial will receive a trial-specific report detailing recruitment and retention for the full trial. Schools will also receive information about the co-primary outcomes and the feasibility of measuring them in the full trial. The full trial will also report a summary of the risk factor data collected in the feasibility trial.
For the re-analysis using PFOA levels, an additional limitation is that we were unable to undertake a similar amount of cleaning or adjusting of the potential confounders to the baseline analysis. We had a total of 9 predictors, some of which are continuous or ordinal, and some of which are categorical (Table 1). In order to ensure that all the predictors had enough variability (defined as more than 20% non-missing data), we grouped some predictors together, so that all predictors were dichotomous. While this improved the variability, it also reduced the representativeness of the groups. For this reason, predictors were chosen to ensure that the groups were still sufficiently balanced. We used a backward selection procedure, starting with the full model, to determine the optimal set of predictors.
To assess the efficacy of the ITI compared to the control condition on mental health outcomes in young people at 2-years follow-up. The primary hypothesis is that there will be a difference between the ITI and control conditions in the mean of the CES-D at 2-years follow-up. The difference between the two conditions will be assessed using an ANCOVA. The level of statistical significance for all models will be set at p < 0.05. 827ec27edc