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. 2023 May 9;2023(5):CD013350. doi: 10.1002/14651858.CD013350.pub2

Pengpid 2013a.

Study characteristics
Methods Study design: randomized controlled trial
Country: South Africa
Setting: university
Eligibility criteria: included were university studies 18 years of age and older who visited public recruitment venues at the university campus and who were risky drinkers (AUDIT>=8). Excluded were students who were pregnant or already in alcohol treatment.
Duration of follow‐up: 12‐months
Informed consent: all participants provided informed consent
Ethical approvals: Medunsa Research and Ethics Committee
Participants Sample size: 152 (81 intervention 71 control)
Description of the target population: university students with risky drinking
Age: 21.9 years (SD = 3.5)
Sex: 12.7% female
Race/Ethnicity: not reported
Marital status: not reported
Harmful alcohol use (baseline): AUDIT=16.2 (SD=7.1)
Co‐occurring disorders: 23.8% PTSD, 12.6% Depression
Interventions Type: non‐pharmacologic
Description: Brief intervention including personalized feedback, health education, simple advice, brief counseling about reducing excessive drinking informed by the Information‐Motivation‐Behavioral Skills Model
Duration and frequency: one 20‐minute session
Delivery and provider: Nurse counselor
Comparison group: one health education session focused on responsible drinking and feedback on alcohol screening delivered by a nurse counselor
Outcomes Primary outcome(s): hazardous alcohol use
Primary outcome measurement tool(s): AUDIT
Secondary outcome(s): heavy episodic drinking, PTSD symptoms, Depressive symptoms, High risk alcohol use, Alcohol dependence,
Secondary outcome measurement tool(s): AUDIT, 7‐item PTSD screener, CES‐D
Time points: 0, 6, 12‐months
Notes Study funding and conflicts of interest: Directorate General for Development Corporation (DGDC) through the Flemish Interuniversity Council (VLIR‐UOS)
Linked study records: None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "After baseline assessment, each student was randomized to either a control or a brief intervention group. Students were randomized using sequentially numbered opaque sealed envelopes prepared according to a computer‐generated (prepared using Stata version 10) randomization allocation sequence. This was carried out separately by an off‐side data management group. After randomization interventionists were instructed to implement the brief intervention." Pg. 2045
Allocation concealment (selection bias) Low risk Quote: "Students were randomized using sequentially numbered opaque sealed envelopes prepared according to a computer‐generated (prepared using Stata version 10) randomization allocation sequence." Pg. 2045
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Research assistant nurses and university students were not blind to their intervention." Pg. 2046
Blinding of outcome assessment (detection bias)
All outcomes High risk Outcomes reported by participant not blind to intervention
Quote: "However, to protect against information biases in the reporting of alcohol use behaviour, the data collection team who assessed the outcomes were blind to the client’s status as intervention arm." Pg. 2046
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: "The extent of the missing component was 3.3% at 12 months. The single follow‐up measurement and the extent of the expected dropout was considered for the statistical method that was used to provide an unbiased estimate of the intervention effect under the principle of intention to treat." Pg. 2049
Selective reporting (reporting bias) Unclear risk Protocol not available