Pbert 2020.
Study characteristics | ||
Methods |
Study design: cluster‐RCT Location: USA Setting: high schools Recruitment: parents of all 9‐12 grade students were sent letters allowing them to opt out of their adolescent participating in the study Study dates: 2014‐16 |
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Participants | N = 146 (across 9 schools) Specialist population?: high school students Definition of smoker used: average of ≥ 5 cpd for the past 7 days Participant characteristics: 56% female; average age: 17 years; 90% white; 69% in reduced or free lunch programme; average cpd: 5; 23% high level of nicotine dependence; 43% elevated depressive symptoms |
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Interventions | All participants had weekly visits with the school nurse for 4 weeks, plus written self‐help materials or 1 of 2 smartphone apps Comparator 1: written self‐help materials (pamphlets) Mode of delivery: written materials, face‐to‐face Intensity: weekly visits with the school nurse over 4 weeks Pharmacotherapy: none Type of therapist/provider: school nurse BCTs: 1.2 Problem solving, 4.1 Instruction on how to perform behaviour Comparator 2: National Cancer Institute QuitSTART App, a free smartphone app developed as a smoking cessation resource for teens Mode of delivery: smartphone app, face‐to‐face Intensity: app intensity unclear, weekly visits with the school nurse over 4 weeks Pharmacotherapy: none Type of therapist/provider: school nurse, smartphone app BCTs: 1.1 Goal setting (behaviour), 1.2 Problem solving, 2.3 Self‐monitoring of behaviour, 15.4 Self‐talk Intervention: craving to quit (C2Q) app adapted for teens, based on core elements of mindfulness training for smoking Mode of delivery: smartphone app, face‐to‐face Intensity: 22 training modules plus 4 bonus modules (5‐15 min/module), weekly visits with the school nurse over 4 weeks Pharmacotherapy: none Type of therapist/provider: school nurse, smartphone app BCTs: 1.1 Goal setting (behaviour), 1.2 Problem solving, 2.3 Self‐monitoring of behaviour |
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Outcomes |
Definition of abstinence: 7‐day point prevalence Longest follow‐up: 6 months Biochemical verification: salivary cotinine < 11.4 ng/mL Other relevant outcomes reported: none |
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Notes |
Relevant comparisons:
Funding source: National Institute on Drug Abuse (R34 DA037886) Author conflicts of interest: "JB owns stock in Claritas MindSciences, the company that developed the Craving to Quit app. The other authors declare that they have no competing interest." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not reported |
Allocation concealment (selection bias) | Unclear risk | Concealment not reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstinence biochemically verified |
Incomplete outcome data (attrition bias) All outcomes | Low risk | At 6‐month follow‐up 8.3% (4/48) were lost to follow‐up in the intervention (C2Q) group, 2.0% (1/50) in the QuitSTART group, and 4.2% (2/48) in the materials group |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes reported |