Segatto 2011.
Study characteristics | ||
Methods |
Study design: Randomized controlled trial Country: Brazil Setting: Emergency department Eligibility criteria: Included were adolescents (16‐25 years) who were seeking care in the emergency department and had consumed alcohol within the past 6 hours. Excluded were individuals without a permanent address within the Sao Paulo, who couldn't complete the interview due to a severe physical condition, having a psychotic disorder or mental/cognitive difficulties, were under arrest, or were receiving substance use treatment. Duration of follow‐up: 3‐months Informed consent: All participants provided written informed consent Ethical approvals: Universidade Federal de Sao Paulo (UNIFESP), Universidade Federal de Uberlandia (UBU) Ethics Committee |
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Participants |
Sample size: 175 (87 intervention, 88 control) Description of the target population: Adolescents/young adults seeking care in the emergency department for alcohol‐related problems Age: 21.8 years (SD=2.6) Sex: 9.7% female Race/Ethnicity: 71.4% Caucasian Marital status: 27.4% married Harmful alcohol use (baseline): Days of use: 10.4 (SD=18.8); Alcohol‐related problems (RAPI) score: 1.00 (SD=0.84); 36.6% met criteria for alcohol dependence Co‐occurring disorders: Not reported |
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Interventions |
Type: Non‐pharmacologic Description: Motivational interviewing focused on developing skills and arguments in favor of behavior change, offering information and guidance, removing barriers, encouraging reflection, establishing a plan for change, an educational brochure, and following up on plan development by telephone Duration and frequency: One 45‐minute session followed by telephone contact at 1‐ and 3‐months Delivery and provider: Senior psychologist Comparison group: One 5‐minute session delivered by a junior research psychologist (post‐graduate or master's level) involving an educational brochure with guidance on alcohol consumption and tips to reduce or avoid alcohol‐related problems followed by telephone contact at 1‐ and 3‐months |
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Outcomes |
Primary outcome(s): Days of alcohol use Primary outcome measurement tool(s): Alcohol consumption questionnaire (ACQ) Secondary outcome(s): Days of light, moderate, and heavy alcohol use, Alcohol‐related problems Secondary outcome measurement tool(s): Rutgers Alcohol Problem Index (RAPI), Alcohol Consumption Risk QUestionnaire (ACRQ) Time points: 0‐ and 3‐months |
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Notes |
Study funding and conflicts of interest: None Linked study records: None |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Eligible subjects were randomized at baseline to one of two groups: motivational interviewing group (MI) plus educational brochure group (EB) or EB alone. A lottery system was employed and it was performed by ER personnel not linked to the clinical trial in order to avoid selection bias" Pg. 227 |
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 "Patients were blinded to the intervention applied." Pg. 228. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcomes reported by participant not blind to intervention |
Incomplete outcome data (attrition bias) All outcomes | High risk | "Analyses were performed to subjects who completed the process ("completers")." Pg. 228 |
Selective reporting (reporting bias) | Unclear risk | Protocol not available |