Quantitative data analysis
The number of screened participants, eligible participants, and of those who refused participation or were not approached will be recorded. The analysis will assess the number of intervention sessions received by participants, and we will collect data on drop-out (including reasons for drop-out if available) from treatment. The intervention topics discussed in meetings will be tabulated.Descriptive statistics will be reported for socio-demographic data for all participants. Nominal and ordinal data will be presented as proportions (frequency), whereas continuous variables will be described utilising central tendency and variability measures. The latter will be selected according to distributions found (parametric or non-parametric), which will be evaluated through normality tests and histograms (probability functions). To assess the effectiveness of DIALOG+, mean and standard deviations (or median and interquartile range) over the three time points (baseline, 6 months and 12 months) will be calculated, and analysis will test the significance of the differences between the means (or other parameters) of outcomes measured. The primary outcome analysis will be the comparison of mean MANSA scores between treatment groups at 6 months follow-up using a mixed-effects model. This model will account for clustering by clinician, baseline values of the outcome (MANSA) and site (Pakistan) as covariates. A full analysis plan will be developed prior to data analysis, which will consider which covariates should be adjusted for in the model and methods for dealing with missing data.The analysis will be conducted on an intention-to-treat basis, and every effort will be made to collect complete data. Patterns of missing data will be explored, and a strategy for dealing with missing values will be developed in the formal statistical analysis plan. Methods for dealing with missing data will depend on the extent, type and distribution of missingness.