Storr 2002 (CC).
Methods | Country: USA Site: 9 public primary schools in Baltimore Focus: classroom management Design: cluster RCT (Group 1: never smoking prevention cohort) | |
Participants | Baseline: 678
Age: 5.3 ‐ 7.7 years (av 5.7)
Gender: 47% F Ethnicity: 86% African Americans, 14% European heritage Baseline smoking data: As age 6, assumed no smoking |
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Interventions | Category: social competence vs. social competence vs. control (classroom management vs. teachers communicating with parents vs. usual contact control) Programme deliverer: teachers Intervention:
Control: usual curriculum and parent‐teacher communications |
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Outcomes | Self reported time to initiation of smoking Follow‐up: At age 12, "... 6 years after end of intervention year..." |
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Notes | Quality of intervention delivery: implementation scores for the CC intervention averaged 60% (range 30% to 78%), and parents in the FSP intervention attended an average of 4/7 sessions; teachers received 60 hrs of training and attended monthly meetings to discuss intervention issues and receive support; fidelity to the interventions was assessed at the monthly meetings and during observation of 3 classroom sessions during the year; the FSP group teachers were asked to document all contacts with parents; and parents reported on the interventions and the skill of the presenters; teachers rated the child's adaptation to school on a 6‐point scale and family and household characteristics were assessed in a 60‐min interview with parents. Statistical quality: Was a power computation performed? The power computation assessed that 150 children per group would be needed; with an av 30% cumulative risk of initiating smoking; between‐group relative risk of initiating smoking = 1.75; and alpha 0.05, 2‐tailed for 80% power. Was an intention‐to‐treat analysis performed? Yes Was a correction for clustering made? No Were appropriate statistical methods used? Yes. Analysis was by general estimating equations with a multivariate response profile approach; Cox regression models to estimate risk of starting smoking. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Within each school, children and teachers were randomly assigned to one of two intervention or control classrooms."; (an e‐mail from Dr. Ialongo states that an SAS programme generated the class lists and randomly assigned students; that children and teachers were randomly assigned to 1st grade within each of the 9 participating schools; and that there was balancing for gender and kindergarten teacher ratings of aggressive disruptive behaviour and academic readiness). Clusters: classrooms Cluster constraints: "A randomised block design was employed, with each of the nine schools serving as a blocking factor..." Baseline comparability: Children in control group somewhat less likely to be male, and African American, more likely to be from 2 parent households, teacher ratings of problem behaviour higher in CC group; these differences were statistically adjusted in the analyses. |
Allocation concealment (selection bias) | Unclear risk | No statement |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No statement |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Storr 2002 (Figure 1): Of the 678 pupils who entered Grade 1, 549 at 6 year (7th grade) follow‐up (189 CC, 192 FS, 168 control); Furr‐Holden 2004 reported ‐ "At follow‐up, 5, 6, 7 years after randomisation (sixth through eighth grades), approximately 84% (566/678) of the sample was available.". No differential attrition among groups across baseline characteristics or smoking status. |
Selective reporting (reporting bias) | Low risk | No selective reporting |