Dataset Information

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.

Discussion

The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention.

Trial registration

Current Controlled Trials ISRCTN43218782.

SUBMITTER: Wilson GB

PROVIDER: S-EPMC3543230 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial.

Wilson Graeme B GB McGovern Ruth R Antony Grace G Cassidy Paul P Deverill Mark M Graybill Erin E Gilvarry Eilish E Hodgson Moira M Kaner Eileen F S EF Laing Kirsty K McColl Elaine E Newbury-Birch Dorothy D Rankin Judith J

Trials 20120924

<h4>Background</h4>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 r ...[more]

PMID: 23006975

Similar Datasets

Project description:BackgroundRisky driving and hazardous drinking are associated with significant human and economic costs. Brief interventions for more than one risky behavior have the potential to reduce health-compromising behaviors in populations with multiple risk-taking behaviors such as young adults. Emergency department (ED) visits provide a window of opportunity for interventions meant to reduce both risky driving and hazardous drinking.MethodsWe determined the efficacy of a Screening, Brief Intervention, and Referral to Treatment (SBIRT) protocol addressing risky driving and hazardous drinking. We used a randomized controlled trial design with follow-ups through 12 months. ED patients aged 18 to 44 who screened positive for both behaviors (n = 476) were randomized to brief intervention (BIG), contact control (CCG), or no-contact control (NCG) groups. The BIG (n = 150) received a 20-minute assessment and two 20-minute interventions. The CCG (n = 162) received a 20-minute assessment at baseline and no intervention. The NCG (n = 164) were asked for contact information at baseline and had no assessment or intervention. Outcomes at 3, 6, 9, and 12 months were self-reported driving behaviors and alcohol consumption.ResultsOutcomes were significantly lower in BIG compared with CCG through 6 or 9 months, but not at 12 months: Safety belt use at 3 months (adjusted odds ratio [AOR], 0.22; 95% confidence interval [CI], 0.08 to 0.65); 6 months (AOR, 0.13; 95% CI, 0.04 to 0.42); and 9 months (AOR, 0.18; 95% CI, 0.06 to 0.56); binge drinking at 3 months (adjusted rate ratio [ARR] 0.84; 95% CI, 0.74 to 0.97) and 6 months (ARR, 0.81; 95% CI, 0.67 to 0.97); and ≥5 standard drinks/d at 3 months (AOR, 0.43; 95% CI, 0.20 to 0.91) and 6 months (AOR, 0.41; 95% CI, 0.17 to 0.98). No substantial differences were observed between BIG and NCG at 12 months.ConclusionsOur findings indicate that SBIRT reduced risky driving and hazardous drinking in young adults, but its effects did not persist after 9 months. Future research should explore methods for extending the intervention effect.

Project description:BackgroundSexually transmitted infections (STIs) are an increasingly critical and costly health problem for American childbearing women. Pregnant women who misuse substances are more likely to engage in risky sexual behavior that leads to STIs. Substance use and risky sex during pregnancy are both associated with numerous negative consequences for the woman and the developing fetus.Study designA two-group, randomized controlled trial.ParticipantsRecruitment of 50 pregnant women (30% Latina; 24.4 years old [SD = 5.31]) with an average of 13 weeks gestation (SD = 4.5 weeks) was conducted at a prenatal clinic in a large inner-city hospital. Recruitment took place between 2015 and 2016, and data analysis took place in 2016.InterventionA computer-delivered, single-session brief motivational intervention plus booster session addressing both substance use and STI risk.ObjectiveTo assess participants' perceptions of the intervention and to examine the preliminary efficacy in reduction of substance use and risky sex at 4-month follow-up assessment.ResultsThere were consistently very high ratings of acceptability of the intervention, ranging between 6.3 and 6.8 on a 1-7 scale. At the 4-month follow-up, participants in the intervention arm reported a significantly larger reduction (54%) in any marijuana or alcohol use compared with participants in the control group (16%) (p = 0.015) based on two-group clustered logistic regression using a generalized estimating equations approach. There was a higher reduction in condomless vaginal sex at follow-up in the health checkup for expectant moms (HCEM) arm than control (27% vs. 5%), although this was not significant (p = 0.127).ConclusionsThe results of this pilot study are encouraging with respect to the acceptability and preliminary efficacy of an intervention in reducing alcohol/marijuana use and condomless sex during pregnancy, supporting the next step of testing the intervention in a larger sample.

Project description:BackgroundThis paper describes the research protocol for a randomized controlled trial of a multimodal mobile sleep intervention for heavy-drinking young adults. Young adults report the highest rates of heavy, risky alcohol consumption and are a priority population for alcohol prevention and intervention efforts. Alcohol strategies that leverage other health concerns and use technology may offer an innovative solution. Poor sleep is common among young adults and is a risk factor for developing an alcohol use disorder. Moreover, young adults are interested in information to help them sleep better, and behavioral sleep interventions address alcohol use as a standard practice.ObjectiveThe primary aim of this study is to assess the effectiveness of a 2-week multimodal mobile sleep intervention for reducing drinks consumed per week among heavy-drinking young adults. We will explore the effects on alcohol-related consequences, assessing quantitative and qualitative sleep characteristics as secondary aims. The study's goals are to identify the optimal combination of sleep intervention components for improving drinking outcomes, the feasibility and acceptability of these components, and the potential mechanisms by which these components may promote alcohol behavior change.MethodsYoung adults (aged 18-25 years) who report recent heavy drinking will be randomly assigned to one of three conditions: mobile sleep hygiene advice (n=30), mobile sleep hygiene advice and sleep and alcohol diary self-monitoring (n=30), or mobile sleep hygiene advice, sleep and alcohol diary self-monitoring, and sleep and alcohol data feedback (n=60). For the feedback component, participants will complete two web-based sessions with a health coach during which they will receive summaries of their sleep and alcohol data, and the potential association between them along with brief advice tailored to their data. All participants will wear sleep and alcohol biosensors daily for 2 weeks for objective assessments of these outcomes.ResultsThe study was funded by the National Institutes of Health in May 2018. Recruitment began in December 2018 and will be concluded in Spring 2021. As of February 4, 2021, we have enrolled 110 participants.ConclusionsUltimately, this research could result in an efficacious, low-cost intervention with broad population reach through the use of technology. In addition, this intervention may substantially impact public health by reducing alcohol use disorder risk at a crucial developmental stage.Trial registrationClinicalTrials.gov NCT03658954; https://clinicaltrials.gov/ct2/show/NCT03658954.International registered report identifier (irrid)DERR1-10.2196/26557.

Project description:BackgroundVarious hospital accreditation and quality assurance entities in the United States have approved and endorsed performance measures promoting alcohol brief intervention (BI) for hospitalized individuals who screen positive for unhealthy alcohol use, the spectrum of use ranging from hazardous use to alcohol use disorders. These performance measures have been controversial due to the limited and equivocal evidence for the efficacy of BI among hospitalized individuals. The few BI trials conducted with hospital inpatients vary widely in methodological quality. While the majority of these studies indicate limited to no effects of BI in this population, none have been designed to account for the most pervasive methodological issue in BI studies presumed to drive study findings towards the null: assessment reactivity (AR).Methods/designThis is a three-arm, single-site, randomized controlled trial of BI for hospitalized patients at a large academic medical center affiliated with the U.S. Department of Veterans Affairs who use alcohol at hazardous levels but do not have an alcohol use disorder. Participants are randomized to one of three study conditions. Study Arm 1 receives a three-part alcohol BI. Study Arm 2 receives attention control. To account for potential AR, Study Arm 3 receives AC with limited assessment. Primary outcomes will include the number of standard drinks/week and binge drinking episodes reported in the 30-day period prior to a final measurement visit obtained 6 months after hospital discharge. Additional outcomes will include readiness to change drinking behavior and number of adverse consequences of alcohol use. To assess differences in primary outcomes across the three arms, we will use mixed-effects regression models that account for a patient's repeated measures over the timepoints and clustering within medical units. Intervention implementation will be assessed by: a) review of intervention audio recordings to characterize barriers to intervention fidelity; and b) feasibility of participant recruitment, enrollment, and follow-up.DiscussionThe results of this methodologically rigorous trial will provide greater justification for or against the use of BI performance measures in the inpatient setting and inform organizational responses to BI-related hospital accreditation and performance measures.Trial registrationNCT01602172.

Project description:BackgroundHeavy episodic (binge) drinking is common among young adults and can lead to injury and illness. Young adults who seek care in the Emergency Department (ED) may be disproportionately affected with binge drinking behavior, therefore provide an opportunity to reduce future risk through screening, brief intervention and referral to treatment (SBIRT). Mobile phone text messaging (SMS) is a common form of communication among young adults and has been shown to be effective at providing behavioral support to young adult drinkers after ED discharge. Efficacy of SMS programs to reduce binge drinking remains unknown.Methods/designWe will conduct a three parallel arm, randomized trial. A convenience sample of adults aged 18 to 25 years attending three EDs in Pittsburgh, PA and willing to participate in the study will be screened for hazardous alcohol consumption. Participants identified as hazardous drinkers will then be allocated to either 12 weeks of weekly SMS drinking assessments with feedback (SA+F), SMS drinking assessments without feedback (SA), or a control group. Randomization will be via an independent and remote computerized randomization and will be stratified by study site. The SA+F group will be asked to provide pre-weekend drinking intention as well as post-weekend consumption via SMS and will receive feedback messages focused on health consequences of alcohol consumption, personalized normative feedback, protective drinking strategies and goal setting. Follow-up data on alcohol use and injury related to alcohol will be collected through a password-protected website three, six and nine months later. The primary outcome for the study is binge drinking days (≥4 drinks for women; ≥5 drinks for men) during the previous month, and the main secondary outcome is the proportion of participants who report any injury related to alcohol in the prior three months.DiscussionThis study will test the hypothesis that a mobile phone text-messaging program will result in immediate and durable reductions in binge drinking among at-risk young adults. By testing an intervention group to an assessment-only and control group, we will be able to separate the effect of assessment reactivity. By collecting pre-weekend drinking intentions and post-weekend consumption data in the SA+F group, we will be able to better understand mechanism of change.Trial registrationClinicaltrials.gov NCT01688245.

Project description:BACKGROUND:Despite intervention efforts to date, the prevalence of risky drinking among adolescents and emerging adults remains high, increasing the risk for health consequences and the development of alcohol use disorders. Peer influences are particularly salient among this age group, including via social media. Thus, the development of efficacious early interventions for youth, delivered with a broad reach via trained peers on social media, could have an important role in addressing risky drinking and concomitant drug use. OBJECTIVE:This paper describes the protocol of a randomized controlled trial (RCT) testing the efficacy of a social media intervention among adolescents and emerging adults who meet the criteria for risky drinking (using the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]), delivered with and without financial incentives for participation, compared with an attention placebo control condition (ie, entertaining social media content), on alcohol consumption and consequences. METHODS:This RCT involved recruiting 955 youths (aged 16-24 years) via advertisements on Facebook and Instagram to self-administer a brief web-based screening survey. Those screening positive for past 3-month risky drinking (AUDIT-C positive: ages 16-17 years: ?3 females and ?4 males; and ages 18-24 years: ?4 females and ?5 males) were eligible for the RCT. After providing consent (a waiver of parental consent was obtained for minors), participants completed a web-based baseline survey and several verification procedures, including a selfie photo matched to Facebook profile photos. Participants were then randomized to join invitation-only secret Facebook groups, which were not searchable or viewable by parents, friends, or anyone not recruited by the study. The 3 conditions were social media intervention with incentives, social media intervention without incentives (SMI), and attention placebo control. Each condition lasted 8 weeks and consisted of bachelor's-level and master's-level therapist electronic coaches posting relevant content and responding to participants' posts in a manner consistent with Motivational Interviewing. Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions. Follow-ups are ongoing and occur at 3, 6, and 12 months poststart of the groups. RESULTS:We enrolled 955 participants over 10 waves of recruitment who screened positive for risky drinking into the RCT. CONCLUSIONS:The findings of this study will provide the critical next step in delivering early alcohol interventions to the youth, capitalizing on social media platforms, which could have significant public health impact by altering alcohol use trajectories of adolescents and emerging adults engaged in risky drinking. TRIAL REGISTRATION:ClinicalTrials.gov NCT02809586; https://clinicaltrials.gov/ct2/show/NCT02809586. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16688.

Dataset Information

Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets