Audrain‐McGovern 2011.
Methods | Study design: RCT Location: USA Setting: children's hospitals Recruitment: through flyers and brochures advertising the study, available at the participating medical sites. Participants were also referred by their physicians. |
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Participants | Defining eligibility criteria?: adolescents aged 14 to 18 years Participant characteristics: 355 adolescent smokers; 195/355 (54.9%) female; mean age: 17.02; mean cpd: 9.8; nicotine dependence: mean modified Fagerstrom Tolerance Questionnaire (MFTQ)= 4.26 Motivation to quit?: not selected on motivation |
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Interventions | Control: structured brief advice (SBA): based on clinical practice guidelines for treating nicotine dependence ‐ the “5 A’s” for those interested in quitting, and the “5 R’s” for participants not interested in quitting smoking. In each session, the 5 A’s/R’s were followed by a review of self‐help materials (smoking cessation print materials, list of resources), and a brief check‐in to see if the adolescent needed help in gaining access to services (e.g. appointment with their physician for pharmacotherapy). Intervention: motivational interviewing (MI), based on motivational enhancement therapy (MET), an adaptation of motivational interviewing. MET adds personalised feedback about assessment results (e.g. adolescent's tobacco use at baseline and during treatment) and collaborative development of a formal change plan to the standard principles and techniques of MI. Provider: counsellor Intensity: the MI intervention consisted of three 45‐minute office sessions and two 30‐minute office or telephone sessions over 12 weeks. Was MI fidelity monitored?: "To promote treatment integrity, all treatment sessions were audio recorded and reviewed weekly by the treatment supervisor, who used an adherence checklist. MI and SBA counselors received extensive training on the treatment protocol and received weekly individual or group supervision." |
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Outcomes | Definition of cessation used: 7‐day point prevalence Length of longest follow‐up: 24 weeks Validation: Saliva cotinine (<= 15 ng/mL classified as abstinent) Was mental health and/or well‐being measured at follow‐up?: yes, however results were not reported by group at follow‐up. Was quality of life measured at follow‐up?: no |
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Funding source | "This study was supported by grant SAP 4100027295 from the Commonwealth of Pennsylvania, Pennsylvania Department of Health". | |
Author conflicts of interest | "The authors have indicated they have no financial relationships relevant to this article to disclose." | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | At this initial assessment, participants were randomly assigned (stratified by precontemplation stage of quitting smoking). |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessment of smoking outcome was blinded and cessation was biochemically verified. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up low and similar across study arms 14/177 (8%) in MI group; 4/178 (2%) in control group. |