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. 2013 Apr 30;2013(4):CD001293. doi: 10.1002/14651858.CD001293.pub3

Hansen 1991.

Methods Country: USA 
 Site: 12 Junior high schools in LA and Orange County, CA.
Adolescent Alcohol Prevention trial (AAPT). 
 Focus: Preventing onset of alcohol abuse, marijuana and tobacco use; primary outcome was alcohol use. 
 Design: Cluster RCT (excluded from analysis).
Participants Baseline: (1987) 3011 
 Age: 7th graders
Gender: 48 ‐ 55% F.
Ethnicity (range by intervention group): Asian 9% ‐ 26% (significant differences); B 1 ‐ 3%; H 11 ‐ 43% (significant differences); W 33 ‐ 52%.
Baseline smoking data: smoking public schools = 4%, private schools = 4%.
Interventions Category: information vs social influences vs information/perceptions vs social influences.
Programme deliverer: project staff (received 2 wks intensive training)
Intervention:
  1. Information (32 classrooms): 4 x 45‐min lessons about the social and health consequences of alcohol, tobacco and drugs.

  2. Resistance training [RT] (33 classrooms): 4 lessons on consequences of using substances, 5 on resisting peer and media pressures to use alcohol, tobacco and other drugs (ATOD)

  3. Normative Education [NE] (27 classrooms): 4 information lessons, 5 lessons on perceptions on prevalence and acceptability of using ATOD

  4. Combined programme of NE and RT (26 classrooms): 3 information, 3.5 resistance skills, 3.5 conservative norms


Control: No control (author considers intervention 1 a placebo comparison)
Outcomes Smoking index, and never/ever smoking/ 30 day smoking. 
 Follow up: 8th grade, 1 yr from baseline.
Notes Part of Adolescent Alcohol Prevention Trial (AAPT); Rohrbach 1993 discusses techniques of implementing the AAPT in Los Angeles, but without any data on student smoking.
Quality of intervention delivery: Process analysis showed high fidelity in the delivery (average 6 on a 7‐point scale for 8 aspects of programme implementation were achieved) of the interventions; but 3 of the independent variables (skill, resistance knowledge and acceptability) were judged by programme specialists to have been affected by programme integrity.
Statistical quality:
Was a power computation performed? No.
Was an intention‐to‐treat analysis performed? Not stated.
Was a correction for clustering made? Yes.
Were appropriate statistical methods used? The unit of allocation was the school, and the unit of analysis in the 1991 paper was class. General linear model analysis of covariance approach was used with classroom means for each composite index and for each dichotomous item. In the 1998 re‐analysis, a combination of multilevel analysis (ML3 programme) and ordinary least‐squares analysis for the post‐test at 2 yrs were used for: (i) the 2370 individuals, (ii) the 120 classes, and (iii) the 12 schools.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No statement on how schools were selected.
"Schools were stratified by size, test scores and ethnic composition and then randomly assigned to receive one of four intervention programs".
Method of randomisation not stated.
Clusters: Schools
Cluster constraint: Stratification by size, test scores and ethnic composition.
Baseline comparability: Not stated.
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 Pre‐test (1987) = 3011; Follow‐up at 1 year: 20% attrition with differential attrition in the resistance training group (P < 0.01), but the authors comment: "Since main effects of Resistance Training did not even approach significance, the interpretation of findings is not threatened".
Selective reporting (reporting bias) Low risk No selective reporting