Table 3 Results of primary (feasibility) outcome measures collected
Recruitment duration of study = 42 months (April 2016 to October 2019) | n or proportion | Comments, if any | ||||
|---|---|---|---|---|---|---|
Number of potential participants approached (total N = 53) | 1.26 participants per month | There was a reduced rate of recruitment from our main partner, YOU, after the first year of recruitment. We later expanded our recruitment to LIHC and CMHA to complete the study | ||||
Number (proportion) of participants who were successfully screened (total N = 49) | 49/53 (92%) | None | ||||
Number (proportion) of successfully screened participants who enrolled | 49/49 (100%) | None | ||||
Rate of participant retention | 30/49 (61.2%) | There was no study intervention related serious adverse effects. 13 participants dropped off at 4Â weeks and an additional 6 dropped off at 8Â weeks for unknown reasons (lost to follow-up) | ||||
Rate of adherence to study protocol | 2 minor deviations | We offered once a week SKY follow-up rather than the planned twice weekly We gave a snack gift card rather than an actual snack Both these deviations were implemented based on participant feedback after first FGD | ||||
Proportion of planned ratings that were completed | Range 90% to 100% | Measure | Week 0 | Week 4 | Week 8 | |
CSI | 47/49 | 34/36 | 29/30 | |||
CIS | 48/49 | 34/36 | 29/30 | |||
GAIN-SPS | 48/49 | 36/36 | 27/30 | |||
Range of available data | 96%-98% | 94%-100% | 90%-97% | |||
Intervention cost per case | CAD $176.2 | Cost for delivery of intervention only | ||||
Completeness of final data for analysis | NA | One participant data sheet was deemed lost at week 0. On all other available data sheets, self-rated scores were legible and analyzable | ||||
Length of time to collect all data | NA | Data collection took place over a period of 47Â months from January 11, 2016, to December 11, 2019 | ||||
Quality of all collected data | NA | There were no shortcomings | ||||
Determining if YOU, Canadian Mental Health Association and other similar community organizations were willing to conduct the study as per study protocol | NA | See further details in the results section | ||||
Determining if there were any capacity issues with partners providing intervention and investigators being able to perform the tasks that they were committed to doing | NA | See further details in the results section | ||||
Determining if there were any problems of entering the data into a computer | NA | None | ||||
Preliminary data about the safety of the intervention | 1 | One participant expressed minor side effects, see further details in the results section | ||||