Kintner 2009.

Methods	Included as outcome evaluation Study design: clustered parallel‐group design, with schools selected as the unit of randomisation Setting: 5 schools in a south‐central Michigan school district Period: dates from recruitment to data collection spanned from September 2006 to June 2007
Participants	Eligible sample frame: 85 pupils found to be eligible Randomised: 66 pupils randomised at the school level: 38 to treatment group and 28 to control group Completed (intervention): 59 pupils completed the trial (7 dropped out of the intervention group) Inclusion criteria: student eligibility criteria included (a) diagnosis of asthma, (b) availability to participate in scheduled classes or make‐up sessions, and (c) verbal and written assent to participate Exclusion criteria: student's expressed unwillingness to participate, lack of consent from parent or legal guardian Baseline characteristics Age of children: 9 to 12 years of age, with mean age, approximately 10.5 years Ethnicity: 32% African American; 15% mixed race; 11% other; 3% Hispanic Socio‐economic status: unclear: mean score > 50 on Nam‐Powers Socioeconomic Status Scale Gender: overall, 52% of participants were male Asthma status: unclear: mean score on the Severity of Illness Scale was > 5.8 for intervention and control groups
Interventions	Intervention: study evaluated the SHARP programme (Staying Healthy ‐ Asthma Responsible and Prepared). Study authors describe that 'the SHARP programme was integrated into the schools as a teaching module. Students met for 50‐minute sessions delivered once a week for 10 weeks from January through March. Students worked through the 100‐page SHARP workbook, which was designed to be colourful, entertaining, educational, and developmentally appropriate, as well as diverse with regards to gender, race, and culture. The programme was incorporated into the existing curriculum as an elective course through inclusion of spelling words, math problems, reading and writing assignments, discussions, demonstrations, and hands‐on learning activities from biology, psychology, and sociology. To support SHARP students, caregivers and others participated in a 3‐hour information sharing programme Control: not clearly stated (usual care) Intensity: targeted asthmatic students received 10 sessions in total Instructor: unclear (potentially teachers, although not clear) Theoretical framework: a lifespan development perspective guided this study and served as the framework for development of the Acceptance of Asthma Model. Cognitive, behavioural, and psychosocial needs of students with asthma were addressed to foster acceptance of asthma by increasing long‐term responsibility for maintaining and promoting health, and for preventing complications Parental engagement: caregivers were involved, but level of engagement is unclear Child satisfaction: not reported Timing of intervention in school day: integrated into class time
Outcomes	Extractable outcomes were collected for: Health‐related quality of life (study authors described participation in activities as a measure of quality of life) Withdrawal
Notes	Considered as a process evaluation but did not include the core components of a process evaluation, with process data collected via use of structured tools Funding source: National Institutes of Health and Staying Healthy – Asthma Responsible and Prepared, National Institute of Nursing Research (Primary); National Heart, Lung, and Blood Institute; National Institute of Allergy & Infectious Diseases; National Institute of Child Health & Human Development
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was computer‐generated following Time 1 data collection
Allocation concealment (selection bias)	Unclear risk	Unclear; few schools were allocated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Interveners and participants were not blinded to randomisation after schools were designated to treatment and control groups
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Evaluators were instructed to not assume or ask the randomisation status of participants. Participants were requested to not disclose randomisation status to evaluators
Incomplete outcome data (attrition bias) All outcomes	Low risk	Relatively low levels of attrition; baseline characteristics of those who dropped out of the intervention group did not differ from characteristics of those who completed post‐intervention assessment
Selective reporting (reporting bias)	Unclear risk	A large body of data was collected; data were aggregated into various scores, hindering their interpretation and use within meta‐analyses
Other bias	Low risk	Missingness ‐ low risk ‐ baseline characteristics of those who dropped out of the intervention group did not differ from characteristics of those who completed post‐intervention assessment Baseline imbalance ‐ low risk ‐ baseline group imbalance was addressed by adjusting for baseline values of outcomes in the analyses Risk of contamination ‐ low ‐ schools were the unit of randomisation
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