Patten 2009.

Methods	Randomised controlled pilot study of a targeted intervention to support pregnant Alaskan Native women to stop smoking in pregnancy. Study conducted in the Y‐K Delta region in Western Alaska (USA), with recruitment from 2007 to 2008.
Participants	Inclusion criteria: Pregnant Alaskan women ≥ 18 years, ≤ 24 weeks' gestation, self‐reported smoking or Iqmik/ST use in the last 7 days, planning to quit in the next 30 days, access to a telephone and VCR/DVD player, and willing to participate in all study procedures. Exclusion criteria: Planning an abortion, current (past 3 months) participation in pharmacological or behavioural tobacco treatment, and another woman from her household had enrolled. Recruitment: 293 women expressed an interest in the study and were referred to study co‐ordinator. 81 did not attend screening appointment, 114 reported not smoking and 4 were ineligible. 35/94 (37%) of the remaining eligible women agreed to participate and were randomised (C = 18, I = 17). Baseline smoking characteristics: Current tobacco use (in past 7 days): Iqmik C = 44% (8), I = 47% (8); Commercial chew C = 22% (4), I = 18% (3); Cigarette smoking C = 33% (6), I = 35% (6). Spouse/partner uses tobacco: C = 78% (14), I = 54% (7). Smoking ban in the home C =89% (16), I = 88% (14). Chewing ban in the home C = 12% (2), I = 19% (3). Baseline characteristics not reported. Progress + coding: Low SES, ethnic minority population.
Interventions	Control: Participants in the control arm received an intervention consistent with the 5‐component treatment (5A’s) recommended for pregnant smokers by the Clinical Practice Guideline: Ask, Advise, Assess, Assist, and Arrange. At the first visit, participants in this condition received a brief (5‐min) face‐to‐face intervention based on the 5A’s and 4 pregnancy and culturally specific brochures. The counsellor encouraged and assisted the participant to set a quit date. Participants requesting NRT or another medication from the counsellor were referred to the YKDRH clinical cessation program and enrolment in this program was tracked as part of this study. Intervention: At the first visit women in the intervention group received: (i) a self‐help guide adapted from the SCRIPT trials (Windsor 1999) and from culturally appropriate brochures developed and used by the YKDRH clinical cessation program. (ii) 15‐25 mins of face‐to‐face counselling based on the 5A's. (iii) a video which was produced that included stories of Alaska Native women who stopped using tobacco during pregnancy. Focus groups suggested that story‐telling was a potentially acceptable intervention component. The counsellor then discussed the video with the woman. (iv) A further 4 x 10‐ to 15‐min proactive interactive sessions were provided by telephone, based on a counsellor manual which was developed based on completed evaluation research, at Weeks 1, 2, 4, and 6. These sessions provided opportunities for the counsellor to teach additional cessation skills and reinforce self‐efficacy. The woman was encouraged to set a quit date at each contact, if she had not quit. Main intervention strategies: Counselling (multiple intervention) compared to a less intensive intervention. Intensity: Frequency (C = 2, I = 6), Duration (C = 2, I = 3). Intervention provided by dedicated study staff: Efficacy study.
Outcomes	Biochemically validated tobacco use in (salivary cotinine < 20 ng/mL) 60 days post randomisation (late pregnancy*). Acceptability to women.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	35 participants were stratified by primary type of tobacco used (Iqmik, commercial ST, or cigarettes) and randomly assigned.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Attrition: C = 1/18 (6%), I = 5/17 (29%). 1 miscarriage in each study arm excluded from this analysis. All other dropouts counted as continuing smokers.
Selective reporting (reporting bias)	Low risk	All primary outcomes reported.
Other bias	Low risk	No other bias detected.
Biochemical validation of smoking abstinence (detection bias)	Low risk	Self‐reported tobacco use status biochemically validated using salivary cotinine (< 20 ng/mL). Some women were using NRT.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not feasible to blind participants and personnel to counselling intervention.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Not reported.
Incomplete implementation	Low risk	Process evaluation showed good treatment compliance and acceptability of intervention.
Equal baseline characteristics in study arms	High risk	Level of education and spouse/partner smoking unequal.
Contamination of control group	High risk	Assessments and interventions provided by the same individual in each community.