Mechanisms of change in control group drinking in clinical trials of brief alcohol intervention: Implications for bias toward the null

Bernstein, Judith; Bernstein, Elizabeth; Heeren, Timothy

doi:10.1111/j.1465-3362.2010.00174.x

Cited by 62 publications

(78 citation statements)

References 88 publications

(131 reference statements)

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“…A protocol for VC/T and referral to substance abuse treatment, if delivered appropriately, is expected to produce major effects [4,6,[29][30][31]. Control group improvements have also been reported in a large number of randomized controlled trials of brief alcohol interventions [32]. These changes, which may also have been operating in our study, have been attributed to a number of factors, including regression to the mean and study participation effects, particularly heightened self-monitoring, and assessment reactivity.…”

Section: Control Group Improvements Over Timesupporting

confidence: 61%

The Impact of a Brief Motivational Intervention on Unprotected Sex and Sex While High Among Drug-Positive Emergency Department Patients Who Receive STI/HIV VC/T and Drug Treatment Referral as Standard of Care

et al. 2012

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This randomized, controlled trial, conducted among out-of-treatment heroin/cocaine users at an emergency department visit, tests the impact on sexual risk of adding brief motivational intervention (B-MI) to point-of-service testing, counseling and drug treatment referral. 1,030 enrollees aged 18-54 received either voluntary counseling/testing (VC/T) with drug treatment referral, or VC/T, referral, and B-MI, delivered by an outreach worker. We measured number and proportion of non-protected sex acts (last 30 days) at 6 and 12 months (n = 802). At baseline, 70% of past-30-days sex acts were non-protected; 35% of sex acts occurred while high; 64% of sexual acts involved main, 24% casual and 12% transactional sex partners; 1.7% tested positive for an STI, and 8.8% for HIV. At six or 12 month follow-up, 20 enrollees tested positive for Chlamydia and/or Gonorrhea, and 6 enrollees HIV sero-converted. Self-reported high-risk behaviors declined in both groups with no significant between-group differences in behaviors or STI/HIV incidence.

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Section: Control Group Improvements Over Timesupporting

confidence: 61%

The Impact of a Brief Motivational Intervention on Unprotected Sex and Sex While High Among Drug-Positive Emergency Department Patients Who Receive STI/HIV VC/T and Drug Treatment Referral as Standard of Care

et al. 2012

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“…However, it is possible that these questions could motivate the control group to modify their drinking. This possibility is supported by recent systematic reviews 70, 71 that confirm that baseline questions can lead participants to re‐evaluate drinking behaviour. The use of these baseline questions could partly explain why the intervention effect appears so modest, as they may bias intervention effects to the null.…”

Section: Discussionmentioning

confidence: 70%

Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone

Crombie

Irvine

Falconer

et al. 2017

Drug and Alcohol Review

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Introduction and AimsDisadvantaged men suffer substantial harm from heavy drinking. This feasibility study developed and evaluated the methods for a trial of a brief intervention delivered by text messages to disadvantaged men. It aimed to test the methods for recruitment and retention, to monitor engagement with the intervention and assess the overall acceptability of study methods.Design and MethodsDisadvantaged men aged 25–44 years who had ≥2 episodes of binge drinking (≥8 units in one session) in the preceding month were recruited. Two recruitment strategies were assessed: recruitment from general practice registers and by a community outreach strategy. Theoretically and empirically based text messages were tailored to the target group.ResultsThe study recruited 67 disadvantaged men at high risk of alcohol‐related harm, exceeding the target of 60. Evaluation showed that 95% of text messages were delivered, and the men engaged enthusiastically with the intervention. Retention at follow up was 96%. Outcomes were successfully measured on all men followed up. This provided data for the sample size calculation for the full trial. Post‐study evaluation showed high levels of satisfaction with the study.Discussion and ConclusionsThis study has shown that disadvantaged men can be recruited and follow‐up data obtained in an alcohol intervention study. The study methods were acceptable to the participants. The men recruited were at high risk of alcohol‐related harms. It also clarified ways in which the recruitment strategy, the baseline questionnaire and the intervention could be improved. The full trial is currently underway. [Crombie IK, Irvine L, Falconer DW, Williams B, Ricketts IW, Jones C, Humphris G, Norrie J, Slane P, Rice P. Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone. Drug Alcohol Rev 2017;36:468‐476]

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“…Also, although all outcome data are derived from patient self-report, the investigation used a reliable timeline follow-back method to document alcohol use and related problems (37). No significant group differences were observed for binge drinking or for other negative drinking consequences; a number of study design considerations including potential for assessment reactivity, exposure to non-study related alcohol SBI training, and the possible training effect of repeated standardized patient interviews could have contributed to reductions in observed treatment effects (17, 25, 59, 60). Finally, the current manuscript does not include a comprehensive cost-effectiveness analysis that would aid in determining whether the statistically significant, yet modest clinical reductions in alcohol consumption observed in the investigation are associated with substantial cost savings from the individual, trauma center or societal perspective.…”

Section: Discussionmentioning

confidence: 91%

Disseminating alcohol screening and brief intervention at trauma centers: a policy-relevant cluster randomized effectiveness trial

et al. 2014

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Background and aims In 2005 the American College of Surgeons passed a mandate requiring that Level I trauma centers have mechanisms to identify and intervene with problem drinkers. The aim of this investigation was to determine if a multilevel trauma center intervention targeting both providers and patients would lead to higher quality alcohol screening and brief intervention (SBI) when compared with trauma center mandate compliance without implementation enhancements. Design Cluster randomized trial in which intervention site (site n =10, patient n =409) providers received 1-day workshop training on evidence-based motivational interviewing (MI) alcohol interventions and four 30-minute feedback and coaching sessions; control sites (site n =10, patient n =469) implemented the mandate without study team training enhancements. Setting Trauma centers in the United States of America. Participants 878 blood alcohol positive inpatients with and without traumatic brain injury (TBI). Measurements MI skills of providers were assessed with fidelity coded standardized patient interviews. All patients were interviewed at baseline, and 6- and 12-months post-injury with the Alcohol Use Disorders Identification Test (AUDIT). Findings Intervention site providers consistently demonstrated enhanced MI skills compared with control providers. Intervention patients demonstrated an 8% reduction in AUDIT hazardous drinking relative to controls over the course of the year after injury (RR =0.88, 95%, CI =0.79, 0.98). Intervention patients were more likely to demonstrate improvements in alcohol use problems in the absence of TBI (p =0.002). Conclusion Trauma center providers can be trained to deliver higher quality alcohol screening and brief intervention than untrained providers, which is associated with modest reductions in alcohol use problems, particularly among patients without traumatic brain injury.

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Mechanisms of change in control group drinking in clinical trials of brief alcohol intervention: Implications for bias toward the null

Cited by 62 publications

References 88 publications

The Impact of a Brief Motivational Intervention on Unprotected Sex and Sex While High Among Drug-Positive Emergency Department Patients Who Receive STI/HIV VC/T and Drug Treatment Referral as Standard of Care

The Impact of a Brief Motivational Intervention on Unprotected Sex and Sex While High Among Drug-Positive Emergency Department Patients Who Receive STI/HIV VC/T and Drug Treatment Referral as Standard of Care

Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone

Disseminating alcohol screening and brief intervention at trauma centers: a policy-relevant cluster randomized effectiveness trial

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