Bruzzese 2008.

Methods	Included as outcome evaluation and process evaluation Study design: parallel‐group design with families selected as the unit of randomisation Setting: study recruited children and their families from one middle school in New York City, New York, USA Period: dates on which study was conducted ‐ intervention and subsequent data collection ‐ not clear; follow‐up data collected 2 months post intervention
Participants	Eligible sample frame: 78 pupils found to be eligible; 24 agreed to participate Randomised: 24 students randomised (at the student/family level): 12 each in control and intervention groups Completed (intervention): 12 students and 10 caregivers in the treatment group, and 11 students and 8 caregivers in the control group, completed immediate follow‐up Inclusion criteria: after completing a case detection survey, eligible students were identified as having had "an asthma diagnosis from a medical provider, and over the past 12 months exhibited asthma symptoms an average of three times per month and used asthma medication" Exclusion criteria: families were excluded if "(1) the child had a co‐morbid disease that affects lung functioning or highly specialized developmental or learning needs, (2) the child and/or the caregiver did not speak English, or (3) the caregiver and child did not live together" Baseline characteristics Age of children: mean age, 12.8 years (grades 6 to 8) Ethnicity: child ethnicity described as Hispanic (41%); White, not of Hispanic origin (17%); African American, not of Hispanic origin (8%); and other (34%) Socio‐economic status: employment status of participating caregivers (but socio‐economic circumstances of family) presented. Unemployed (8%); employed part‐time (21%); employed full‐time (71%). Data on highest educational level completed by caregiver were also presented, with 66% having post‐compulsory education Gender: males accounted for 13 of the child participants (54%), and females for 11 of the participants (46%) Asthma status: direct information on severity not presented
Interventions	School type: junior/middle Intervention description: OAS, ASMA, caregiver education Control description: usual care/nothing Theoretical framework: social cognitive theory and cognitive‐behavioural therapy Intervention: implemented "Asthma: It's a Family Affair!" intervention. "Intervention students received six group sessions on prevention and management of asthma. Lesson topics included: (1) information and feelings about asthma; (2) asthma medication; (3) prevention and management of asthma symptoms; (4) problem‐solving and coping with negative feelings about asthma; and (5) communicating about asthma to peers and teachers, relaxation exercises, and healthy behaviours, including smoking refusal skills and avoiding exposure to secondhand smoke". The sixth session included a comprehensive review designed to reinforce key messages and to enhance students' confidence in managing their asthma. Curriculum was based on existing materials from Coping with Asthma at Home and at School, OAS, and ASMA. Caregivers participated in five 90‐minute group sessions held once per week intended to support the child's autonomy and development of asthma self‐management skills Control: no treatment (usual care) Intensity: children received 6 lessons on a weekly basis Instructor: children's sessions were delivered by a developmental psychologist Theoretical framework: integration of 4 psychological theories: social cognition theory, cognitive‐behavioural theory, and 2 forms of family systems theory (parenting styles and behavioural family systems theory) Parental engagement: low attrition among caregivers and high levels of satisfaction Child satisfaction: high levels of satisfaction: "All students reported that the intervention gave them a better understanding of asthma, and 91% reported that the handouts helped them understand the topics discussed. Many reported that the best aspect of the program was 'talking about my asthma'" Timing of intervention in school day: not reported
Outcomes	Extractable outcomes were collected for: Experience of daytime and night‐time symptoms Withdrawal from the study Core processes/outcomes evaluated (child level): attrition, dosage, adherence
Notes	Process evaluation category: named section Breadth and depth: neither broad nor deep Voice of children given prominence: featured but not sufficiently Funding source: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information on how randomisation occurred
Allocation concealment (selection bias)	Unclear risk	No information on how allocation was concealed
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information; blinding was not assessed by study authors
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information; blinding was not assessed by study authors
Incomplete outcome data (attrition bias) All outcomes	Low risk	Few participants dropped out (1 out of 12 students in the control group)
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting
Other bias	Unclear risk	Missingness ‐ low risk ‐ no evidence of missing indicators Baseline imbalance ‐ low risk ‐ no evidence of systematic differences in baseline characteristics Contamination ‐ high ‐ randomisation was by family
Transparent and clearly stated aims	Low risk	Study aims were clearly stated
Explicit theories underpinning and/or literature review	Low risk	Intervention development was guided by social cognitive theory and cognitive‐behavioural therapy
Transparent and clearly stated methods and tools	Unclear risk	Medium bias ‐ tools were poorly described
Selective reporting	Unclear risk	As data collection tools were not that well stated, it is difficult to assess whether results show any evidence of selective reporting
Harmful effects	Unclear risk	Not considered by trial authors
Population and sample described well	Low risk	Population and sample were well described
Continuous evaluation	Unclear risk	Data were collected before and after the intervention; however the level of participation was low
Evaluation participation equity and sampling	High risk	Little evidence of evaluation from children
Design and methods overall approach	Unclear risk	Unclear how data were collected
Tools and methods of data collection reliable/credible	High risk	Unclear whether tools used had been validated
Tools and methods of data analysis reliable/credible	Low risk	Analysis appears to reflect the data
Performance bias/neutrality/credibility/conformability	Unclear risk	Unclear whether this was given consideration
Reliability of findings and recommendations	Low risk	Reliability of findings clear; conclusions justified
Transferability of findings	High risk	No consideration given to transferability of findings
Overall risk of bias of process evaluation	Unclear risk	Medium bias