Cicutto 2005.

Methods	Included as outcome evaluation Study design: clustered parallel‐group design with schools selected as the unit of randomisation Setting: study was conducted across 26 elementary schools in a suburb of Toronto (Canada) Period: dates on which the study was conducted ‐ including intervention and subsequent data collection ‐ not clear; intervention and data collection was conducted over the period of a year
Participants	Eligible sample frame: 40 elementary schools were randomly selected from a pool of 147 potential elementary schools for inclusion in the Toronto area. Parents and children were invited to participate, and eligibility was assessed (see below). Based on the information returned, 26 schools had sufficient numbers of pupils (more than 7 pupils per school) to allow the trial to go ahead. In total, 297 eligible pupils were identified across the 26 schools Randomised: 256 pupils randomised at the school level: 132 to the treatment group and 124 to the control group Completed (intervention): 248 pupils remained at the 6‐month data collection point: 130 treatment group children and 118 control group children. 239 children completed the intervention: 121 in the treatment and 118 in the control group. Inclusion criteria: students were eligible for participation if they were reported as (I) having physician‐diagnosed asthma, (ii) having used an asthma medication (i.e. bronchodilator and/or anti‐inflammatory agents) for breathing difficulties, and (iii) having experienced asthma symptoms 3 or more times in the past year. Students had to meet all 3 criteria to be eligible Exclusion criteria: children were excluded from the study if they had a second (major) chronic illness with a pulmonary component (e.g. cystic fibrosis) Baseline characteristics Age of children: mean age, 8.6 years across treatment and control groups Ethnicity: not reported Socio‐economic status: indicative evidence that none of the children were from low‐income families: "The average income of the parent/guardian who participated in the study was approximately $53,000.00 (Canadian dollars) with a range of $20,500.00 to $200,000.00. In Canada, low‐income families earn $19,000.00 per year" Gender: treatment group: 58.3% male, 41.7% female; control group: 59.6% male, 40.4% female Asthma status: At baseline, according to parental report: Treatment group: 68.2% of children had mild asthma, 20.4% had moderate asthma, 5.4% had severe asthma; Control group: 69.5% of children had mild asthma; 23.4% had moderate asthma; 7.3% had severe asthma
Interventions	Intervention: children in treatment group received "Roaring Adventures of Puff" (RAP) intervention. This consisted of 6 sessions that included: "(1) getting to know each other, goal setting, use of a peak flowmeter, and diary monitoring; (2) trigger identification, control, and avoidance, and basic pathophysiology; (3) medications and the proper use of inhalers; (4) symptom recognition and action plan use; (5) lifestyle, exercise, and managing an asthma episode; and (6) sharing asthma information with teachers and parents". Parents were invited to attend the final session and were encouraged to take part in assisting with children's homework Control: usual care Intensity: children attended 6 sessions 50 to 60 minutes in length that were held once a week over 6 consecutive weeks Instructor: asthma educator Theoretical framework: theories involving social cognitive theory and self‐regulation underpinned the intervention Parental engagement: reported as low ‐ < 20% of children had a parent who attended the final session Child satisfaction: not reported Timing of intervention in school day: sessions took place over the lunch period
Outcomes	Extractable outcomes were collected for: Exacerbations leading to hospital admission Asthma symptoms leading to emergency hospital visits Absence from school Days of restricted activity
Notes	Considered for process evaluation but not deemed to address implementation questions nor to provide any in‐depth study of implementation processes Funding source: Change Foundation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was centrally controlled by a computerised randomisation programme
Allocation concealment (selection bias)	Low risk	Randomisation was centrally controlled by a computerised randomisation programme
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not addressed by study authors
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessors and participants were blinded to group assignment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low levels of attrition/dropout with outcome data collected from 93% of students, who were randomised
Selective reporting (reporting bias)	Unclear risk	Not all outcomes were fully reported, but they were described narratively in some places
Other bias	Low risk	Missingness ‐ unclear risk ‐ intention‐to‐treat analyses were implemented, although the extent of missingness (as opposed to attrition) is unclear Baseline imbalance ‐ low risk ‐ demographic and asthma‐related characteristics were similar between the 2 study groups and did not demonstrate statistically significant differences Risk of contamination ‐ low ‐ allocation was provided at the school level
Transparent and clearly stated aims	Unclear risk	N/A
Explicit theories underpinning and/or literature review	Unclear risk	N/A
Transparent and clearly stated methods and tools	Unclear risk	N/A
Selective reporting	Unclear risk	N/A
Harmful effects	Unclear risk	N/A
Population and sample described well	Unclear risk	N/A
Continuous evaluation	Unclear risk	N/A
Evaluation participation equity and sampling	Unclear risk	N/A
Design and methods overall approach	Unclear risk	N/A
Tools and methods of data collection reliable/credible	Unclear risk	N/A
Tools and methods of data analysis reliable/credible	Unclear risk	N/A
Performance bias/neutrality/credibility/conformability	Unclear risk	N/A
Reliability of findings and recommendations	Unclear risk	N/A
Transferability of findings	Unclear risk	N/A
Overall risk of bias of process evaluation	Unclear risk	N/A