Signor 2013.
Study characteristics | ||
Methods |
Study design: Randomized controlled trial Country: Brazil Setting: Telephone‐based intervention Eligibility criteria: Included were self‐reported alcohol users from Brazil who had consumed alcohol in the past month and who were seeking help for alcohol use problems through a hotline or a health provider. Excluded were individuals who were unable to answer interview questions due to cognitive difficulties or the effects of alcohol/drugs and those who could not be contacted for a follow‐up interview. Duration of follow‐up: 6‐months Informed consent: Not reported Ethical approvals: Universidade Federal de Ciencias de Saude de Porto Alegre (UFCSPA) Ethics Committee |
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Participants |
Sample size: 637 (293 intervention, 344 control) Description of the target population: Help‐seeking individuals in general population Age: 27 years (Range 21‐37) Sex: 29% female Race/Ethnicity: Not reported Marital status: 30% married or cohabitating Harmful alcohol use (baseline): 84% met criteria for dependence Co‐occurring disorders: Not reported |
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Interventions |
Type: Non‐pharmacologic Description: Brief motivational intervention including self‐help material sent by mail, a 20‐minute brief motivational interview session by phone along with a 10‐minute assessment, and 7 follow‐up calls over a 6‐month period Duration and frequency: One 30‐minute session and 7 follow‐up calls at 1 day, 3 days, 7 days, 1 month, 2 months, 3 months and 6 months Delivery and provider: Trained university students from health programs Comparison group: Necessary advice provided by phone from trained university students from health programs and self‐help material sent by mail |
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Outcomes |
Primary outcome(s): Abstinence Primary outcome measurement tool(s): Not reported Secondary outcome(s): Not reported Secondary outcome measurement tool(s): N/A Time points: 6‐months |
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Notes |
Study funding and conflicts of interest: Brazilian National Secretariat on Drug Policies (Secretaria Nacional Antidrogas, SENAD), Associacao Mario Tannhauser de Ensino Pesquisa e Assistencia (AMTEPA), Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (CNPq), Coordenacao de Aperfeicoamento de Pessoal d Nivel Superior Linked study records: None |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Group allocation was performed using a Microsoft H software application that applied a random number technique." Pg. 255 |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel cannot be blinded for this type of intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcomes reported by participant not blind to intervention "Counselors were blinded to the collection of follow‐up data by a random assignment that used scripts to guide the telephone interviews." Pg. 256 |
Incomplete outcome data (attrition bias) All outcomes | High risk | "Based on continuous abstinence time and the ITT principle, in which dropouts are considered people who relapse, a Cox proportional hazards model detected a significant difference between the BMI and control groups" Pg. 256 "The study attrition rate was 76.9% (490 participants dropped out)." Pg. 256 |
Selective reporting (reporting bias) | Unclear risk | Protocol not available |