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. 2012 Aug 15;2012(8):CD009325. doi: 10.1002/14651858.CD009325.pub2

Gilchrist 1987.

Methods Country: United States of America
Design: Randomized controlled trial, cluster, nested
Objective/s: To determine the effectiveness of a skills enhancement model for preventing substance abuse with American Indian adolescents
Study Site: Reservation and non‐reservation settings in the Pacific Northwest; Three intervention sites (one urban and two rural) and four control sites (one urban and three rural)
Programme name: Not reported
Methods of analysis: Not reported
Cluster adjustment made: No
Participants Eligible for study (n‐value): Not reported
Recruited:
Clusters: n = 3 intervention sites (one urban and two rural); n = 4 control sites (one urban and three rural)
Individuals: n = 109
Completed: n = 39 intervention; n = 58 control
Age: Intervention mean = 11.22 +1.15; Control mean = 11.46 +1.43
Gender: Intervention = 52% female; Control = 46% female
Ethnicity: Native American
Socio‐economic status: Not reported
Recruitment means: Not reported however intervention occurred in schools
Interventions Theoretical basis: Skills enhancement approaches; SODAS (Stop, Options, Decide, Act/communication skills, Self‐praise) problem solving model
Intervention description/s: Ten session skills enhancement programme through school curriculum delivered by two people, one a Native American research staff member and the other an Indigenous community leader; Intervention included: discussion of myths concerning Native American drug use, impact of stereotypes on behaviour, provision of health education information through games, handouts, films and posters, group discussions and peer guest speakers sharing personal reasons for rejecting drug use, discussions around SODAS problem solving model, opportunities for skills practice, creation of videotape and adult guest speaker invited from tribal alcohol treatment programme
Control description/s: Test only control subjects
Duration of intervention: Ten, 60‐ minute classroom sessions
Intervention delivered by: Two person team consisting of one Native American research staff member and one Indigenous community leader (e.g., Native American teachers, school counsellors and alcohol and drug treatment staff members whom subjects knew well and respected; All professional personnel received 10 hours of training about how to deliver the prevention curriculum
Outcomes Method of outcome collection: Not reported
Pre‐specified outcome data: Demographics, drug knowledge scales, attitude scales, interpersonal behaviour tests and if any/amount of alcohol, marijuana, tobacco and inhalants used
Validation: None reported
Follow‐up period: Six months
Number of follow‐up periods reported: Two; post‐test and 6 months
Process measures: Attendance rates for the intervention condition indicated that 83% of subjects completed the 10 session programme, bulk of remaining subjects attended at least 8 sessions
Definition of tobacco use: Not reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomization mentioned however methods not described
Allocation concealment (selection bias) Unclear risk No mention of allocation concealment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Due to the nature of the intervention it is not possible to blind participants
 
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No mention of blinding for outcome assessors
Incomplete outcome data (attrition bias) 
 All outcomes High risk Attrition reported however reasons not specified and no mention of any missing outcome data or how it was addressed
Selective reporting (reporting bias) Unclear risk Baseline outcomes reported and similar between groups
Imbalance of outcome measures at baseline Low risk Baseline characteristics reported and similar between groups
Comparability of intervention and control group characteristics at baseline Unclear risk Insufficient information to permit judgement of yes or no
Protection against contamination Unclear risk Insufficient information to permit judgement of yes or no
Selective recruitment of participants Unclear risk Insufficient information to permit judgement of yes or no