Cicutto 2013.

Methods	Included as process evaluation and outcome evaluation Intervention study design: cluster RCT Setting: 170 primary/elementary schools from 5 public health units across Ontario, Canada Period: not reported
Participants	Eligible sample frame: 180 schools were eligible and 170 schools were randomised (85 in each arm). 2502 families were eligible and 1316 were enrolled Randomised: 1316 participants were enrolled Completed (intervention): 1172 completed the study; 144 children withdrew, representing an 11% withdrawal rate Inclusion criteria: parental report of physician‐diagnosed asthma, use of asthma medications, asthma symptoms at least 3 times in the past year, enrolment in grades 1 through 5 at school, ability to speak English, no other chronic conditions that could mimic asthma Exclusion criteria: not reported Baseline characteristics Age of children: 8 years old Ethnicity: not reported Socio‐economic status: 26.4% of children had a mother who did not have a high school diploma Gender: the sample comprised 57.4% males; 58.4% of control children and 56.6% of intervention children were male Asthma status: asthmatic only
Interventions	School type: primary/elementary Intervention description: Roaring Adventures of Puff Control description: usual care/nothing Theoretical framework: social cognitive theory Intervention: workshops included goal setting and self‐monitoring, trigger identification, control and avoidance, basic pathophysiology, medication and proper inhaler use, symptom recognition and the asthma action plan, lifestyle and exercise, managing an asthma exacerbation, and showcasing learning with teachers and parents. The intervention used interactive techniques to educate the children. Make‐up sessions were available for those who missed a class Intensity: children attended six 45‐minute sessions Instructor: public health nurses Parental engagement: difficulty in getting parents/guardians involved Child satisfaction: not reported Timing of intervention in school day: lunchtime
Outcomes	Extractable outcomes collected for: Asthma symptoms leading to emergency hospital visits Parent‐reported absence from school Days of restricted activity Unplanned visit to hospital or GP due to asthma symptoms Health‐related quality of life Withdrawal Core processes evaluated (child level): attrition
Notes	Process evaluation category: stand‐alone and Integrated (2 papers) Breadth and depth: breadth ‐ not depth Voice of children given prominence: not featured Funding source: Ontario Ministry of Health and Long Term Care
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random sequence: of the 180 schools, 170 schools with the largest numbers of students with asthma were randomised to intervention or control groups through a computer‐generated table of random numbers
Allocation concealment (selection bias)	Low risk	Central allocation indicated: of the 180 schools, 170 schools with the largest numbers of students with asthma were randomised to intervention or control groups through a computer‐generated table of random numbers
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not clear whether measures were taken and whether this would have influenced the outcome
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Study authors reported: "Data collectors were blinded to group assignment. A post survey of data collectors revealed that blinding was successful. Data collectors became unblinded to group assignment for 9% of participating families, which occurred during the data collection interviews with parents/guardians"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Attrition data were presented, although data were not disaggregated by treatment status
Selective reporting (reporting bias)	Unclear risk	Absence of clear numbers hinders interpretation of some data
Other bias	Unclear risk	Missingness ‐ high risk ‐ evidence of unexplained missing data in Table 2 Baseline imbalance ‐ low risk ‐ study authors reported: "Randomisation was successful in that comparison of baseline variables for the control and experimental groups suggested they were similar or balanced before the intervention" Risk of contamination ‐ low ‐ unit of randomisation was at the school level, reducing the threat of contamination
Transparent and clearly stated aims	Low risk	Study aims were clearly stated
Explicit theories underpinning and/or literature review	Low risk	Intervention development was informed by social cognitive theory
Transparent and clearly stated methods and tools	Low risk	Tools and methods were clearly reported
Selective reporting	Unclear risk	Unclear how this was addressed
Harmful effects	Unclear risk	Study authors did report on low parental engagement; however they offered no explanation as to why all treatment schools did not adopt the policy
Population and sample described well	Unclear risk	Individual schools were not described sufficiently
Continuous evaluation	Low risk	Policy development was monitored early on; 2 sets of data were collected after baseline
Evaluation participation equity and sampling	High risk	Stakeholders were not directly involved
Design and methods overall approach	Low risk	Pre‐post assessment data were collected
Tools and methods of data collection reliable/credible	Low risk	Study authors used validated data collection tools
Tools and methods of data analysis reliable/credible	Low risk	Data analysis methods used were suitable for the data
Performance bias/neutrality/credibility/conformability	Unclear risk	Blinding was attempted but was not always successful
Reliability of findings and recommendations	Low risk	Clearly reported by study authors. Findings appear to be reliable
Transferability of findings	Unclear risk	Not explored
Overall risk of bias of process evaluation	Low risk	Important indicators, for example, design methods and continuous evaluation, were at low risk