Kamal 2020.
| Study characteristics | ||
| Methods |
Study design: randomized controlled trial Country: India Setting: university Eligibility criteria: students were included if they screened positive for hazardous alcohol use. Students with harmful alcohol use or displaying severe withdrawal symptoms were excluded. Duration of follow‐up: 3 months Informed consent:all participants provided informed consent Ethical approvals: study procedures were approved by the PGIMER Institute Ethics Committee |
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| Participants |
Sample size: 130 (64 intervention, 66 control) Description of the target population: university students with hazardous alcohol use Age: 19 years Sex: 80.8% male Race/Ethnicity: not reported Marital status: not reported Harmful alcohol use (baseline): mean AUDIT score is 9.53 (SD=2.0) in intervention group and 9.6 (SD = 2.1) in control group Co‐occurring disorders: not reported |
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| Interventions |
Type: non‐pharmacologic Description: Brief intervention based on the FRAMES model involving personalized feedback, advice, menu of options, empathy, self‐efficacy, pros/cons, intent/reason to quit, brainstorm alternatives and means to quit, and goal setting. Duration and frequency: one session (15‐20 minutes) Delivery and provider: trained nurse Comparison group: Brief advice involving AUDIT feedback (1 session) |
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| Outcomes |
Primary outcome(s): hazardous alcohol use Primary outcome measurement tool(s): AUDIT Secondary outcome(s): binge drinking, transition from high to low‐risk alcohol use Secondary outcome measurement tool(s): AUDIT Time points: 0, 3 months |
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| Notes |
Study funding and conflicts of interest: not reported Linked study records: none |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "One of the investigators (DK) had generated a random sequence by the Statistical Package for Social Sciences (16.0). The nature of intervention was decided on the odd and even numbers. The sequen‐ tially numbered opaque sealed envelopes were used for allocation concealment. The envelopes would be opened by DK immediately before the intervention and she would telephonically inform the nurse, KK, about the type of the intervention." Pg. 286 |
| Allocation concealment (selection bias) | Low risk | Quote: "The sequentially numbered opaque sealed envelopes were used for allocation concealment." ‐ Pg. 286 |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind the providers and participants given the nature of the intervention. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "we used the self‐administered paper version of the AUDIT, for initial screening as well as for follow‐up. Therefore, the participants them‐ selves were outcome assessors. Hence, the study could be considered as double‐blind, because although the nurse could know the group of each subject, the AUDIT form was completed by the subject, not the nurse." Pg. 286 Outcome assessment based on self report by unblinded participant |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Data were analyzed by using Statistical Package for Social Sciences (IBM SPSS Statistics 16.0). Last observation carried forward method was used to replace missing values (loss to follow‐up)." Pg. 286 |
| Selective reporting (reporting bias) | Unclear risk | Not reported |