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. 2018 Oct 5;2018(10):CD009927. doi: 10.1002/14651858.CD009927.pub2

Bond 2004.

Methods Study name: The Gatehouse Project
Study design: cluster RCT
Intervention arm(s): whole‐school intervention
Comparator arm (s): N/S
Sample size calculation performed: yes
Subgroups prespecified: none
Subgroup analyses: NA
Start date: 1997
Duration of follow‐up: 4 years
Number of follow‐ups: 2
Follow‐up time points: end of school years 1997, 1998, 1999, 2001 (end of school year, 1 year, 2 years, 4 years)
ICC (if reported): 0.01 to 0.06
Participants Number of schools randomised: 26
Number of participants randomised (total and by arm): 12 (intervention), 14 (control)
Age (range or mean (SD)) or grade at the start: 13 to 14 years
Gender: 52% female (intervention), 54% female (control)
Ethnicity: non‐Australian born: 16% intervention, 9% control. Student with first language other than English: 24% intervention, 22% control
SES: N/S
Inclusion criteria: N/S
Exclusion criteria: N/S
Interventions Randomisation before or after baseline survey: before
Duration of the intervention (excluding follow‐up): 24 months
Description of the intervention: The Gatehouse Project was a school‐based primary prevention programme, which included both institutional and individual focused components to promote the emotional and behavioural well‐being of young people in secondary schools. Components of the intervention included establishment and support of an adolescent health team, identification of risk and protective factors in the social and learning environment from student surveys, and use of these data for identification of effective strategies to address these issues. A curriculum component was also implemented.
Brief description of the theoretical model: health promoting schools framework, ecological approach
Description of the comparator: N/S
Outcomes Primary outcomes: depression, alcohol use, tobacco use, marijuana use, bullying
Secondary outcomes: poor availability of attachments, arguments with 3 or more people
Setting Country: Australia; State: Victoria
Setting: secondary schools
Focus: universal
Process measures Process data reported: yes
Method (qualitative or quantitative): both
Description: field notes, informant interviews, school audit
Statistics Sample size: 1335 intervention, 1342 control
Unit of randomisation: school
Unit of analysis: school
Method to promote equivalence between groups: stratification
Statistical models: ordinal logit models
Baseline differences adjustment: N/S
Repeated measures methods in analysis: no
Notes Equity: baseline information on gender, ethnicity, parental separation, non‐Australian born
Funding: grants from the Queen’s Trust for Young Australians, Victorian Health Promotion Foundation, National Health and Medical Research Council and Department of Human Services, Victoria, Murdoch Children’s Research Institute, Sydney Myer Fund, Catholic Education Office
Randomisation method, e.g. block, stratification, computer: stratification by school administration
Clustering accounted for in sample size calculation (if relevant): yes
Cluster randomisation methods to account for clustering in analysis: yes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details provided
Allocation concealment (selection bias) Unclear risk No details provided
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not blinded but intervention was integrated with usual curriculum and administrative processes
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No details provided
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Low levels of attrition and non‐differential rates between study arms
Selective reporting (reporting bias) Unclear risk No protocol available
Other bias Unclear risk Proportion responding to baseline survey differed between study arms (81% from intervention schools, 68% from comparison schools).