title: Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care.
  
  
  METHODS
  The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742) attending their booking appointment with a community midwife (n = 31) in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C). Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120). Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control) or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention). As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants' views on instruments and procedures will be sought to confirm their acceptability.
  
  
  CONCLUSIONS
  The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN43218782.
authors.affiliation: Institute of Health & Society, Baddiley-Clark Building, Newcastle University, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
authors.forename: Graeme B
authors.initials: GB
authors.lastname: Wilson
authors.forename: Ruth
authors.initials: R
authors.lastname: McGovern
authors.forename: Grace
authors.initials: G
authors.lastname: Antony
authors.forename: Paul
authors.initials: P
authors.lastname: Cassidy
authors.forename: Mark
authors.initials: M
authors.lastname: Deverill
authors.forename: Erin
authors.initials: E
authors.lastname: Graybill
authors.forename: Eilish
authors.initials: E
authors.lastname: Gilvarry
authors.forename: Moira
authors.initials: M
authors.lastname: Hodgson
authors.forename: Eileen F S
authors.initials: EF
authors.lastname: Kaner
authors.forename: Kirsty
authors.initials: K
authors.lastname: Laing
authors.forename: Elaine
authors.initials: E
authors.lastname: McColl
authors.forename: Dorothy
authors.initials: D
authors.lastname: Newbury-Birch
authors.forename: Judith
authors.initials: J
authors.lastname: Rankin
mesh_terms: D000428:Alcohol Drinking / Q000009:adverse effects / Q000517:prevention & control* / Q000523:psychology; D002985:Clinical Protocols; D004739:England; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008425:Maternal Behavior / Q000523:psychology*; D008880:Midwifery; D062405:Motivational Interviewing; D010865:Pilot Projects; D011247:Pregnancy; D011248:Pregnancy Complications / Q000209:etiology / Q000517:prevention & control*; D011295:Prenatal Care / Q000379:methods*; D011614:Psychotherapy, Brief; D012107:Research Design; D040242:Risk Reduction Behavior; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome