Taylor 2014.
Methods | Design: cluster randomized trial; 16 high schools (urban and rural) allocated to conditions Location: KwaZulu‐Natal, South Africa Time frame: 2009 Sample size estimation and outcome of focus: no information |
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Participants | General with N: 16 high schools; 816 students Inclusion criteria: 2 of 11 districts (1 urban and 1 rural); 16 of 1580 high schools on Department of Education list; randomly selected grade 8 classes (1st year high school) Exclusion criteria: no information |
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Interventions | Study focus: teenage pregnancy prevention Theory or model: I‐Change model from 2005 (DeVries 2013); integration of ideas from Theory of Planned Behavior, Social Cognitive Theory, Transtheoretical Model, Health Belief Model, and goal setting theories
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Outcomes | Primary: been pregnant or caused pregnancy; condom use (any); condom use consistency as 4‐point scale from 1 (never) to 4 (always) Secondary: attitudes to teen pregnancy (pro and con scales); intent to prevent pregnancy and to use condoms Follow‐up: 4 months postprogram (8 months after baseline) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No specifics on sequence generation: 16 of 1580 schools selected; geographical stratification; randomly allocated schools to groups |
Allocation concealment (selection bias) | Unclear risk | Students invited from 1 randomly selected grade 8 class |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Presume no blinding of participants or providers; not feasible due to type of intervention |
Blinding of outcome assessment (detection bias) | Unclear risk | No mention |
Outcome measures | High risk | Contraceptive use and pregnancy by self‐report |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up: intervention 11% (48/431); control 23% (89/385); differential losses |
Other bias | High risk | Analysis for cluster randomized trial: multivariate linear and logistic regression models included covariates of age, gender, socioeconomic status, sexual experience, and baseline scores. Analysis of behavioral outcomes based on who had sex (could be affected by intervention), rather than all randomized (high risk) |