Christoff 2015.
Study characteristics | ||
Methods |
Study design: 3‐arm parallel‐group RCT Duration of study: 3 months |
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Participants |
Country: Brazil Income classification: upper‐middle income between 2006 and 2015 Geographical scope: urban Healthcare setting: university Mental health condition: Alcohol Use Disorder Population (mention whether patient, carer, or dyad) 1. Age: 18 years and older 2. Gender: both 3. Socioeconomic background: 58% of participants were in socioeconomic class B 4. Inclusion criteria (including threshold cutoff score of measurement tool) a. College students from 2 universities with alcohol or substance abuse b. ASSIST score 4 to 26 (moderate) and above (dependent) for substance use and/or 11 to 26 (moderate) and above (dependent) for alcohol use c. Ability and consent to participate in 2 sessions that lasted from 5 minutes (control group) to 40 minutes (other 2 groups) with no compensation or payment for participation d. Declaration that they would not engage in other substance treatments/programmes before or during the study 5. Exclusion criteria a. None |
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Interventions |
Stated purpose: to evaluate the efficacy of a computer‐based intervention programme, called ASSIST/Motivational Brief Intervention (ASSIST/MBIc), for substance involvement compared with only feedback about ASSIST scores (control group) and feedback plus MBI in an interview (ASSIST/MBIi) INTERVENTION 1 (n = 128) Name: computer‐based ASSIST/Motivational Brief Intervention (ASSIST/MBIc) Delivered by: computer programme Title/name of PW and number: none 1. Selection: none 2. Educational background: none 3. Training (contents, duration, by whom): none 4. Supervision: none Intervention details: NA (will not analyse) 1. Duration/frequency: NA (will not analyse) INTERVENTION 2 (n = 106) Name: feedback plus MBI in an interview (ASSIST/MBIi) Delivered by: CP (community professional) Title/name of PW and number: interviewers ‐ 6 1. Selection: not specified 2. Educational background: not specified 3. Training: in ASSIST and motivational interviewing by principal investigator using the WHO manual 4. Supervision: none specified Intervention details 1. Duration/frequency: a single‐session brief intervention following the ASSIST interview lasting 5 to 20 minutes. Contents: a personal face‐to‐face intervention that provides feedback on scores, gives advice about identifying potential problems, encourages behavioural change, allows participants to report substance‐related problems, lists the advantages and disadvantages of using the substance(s), lists skills to cope with risky behaviours related to the substance(s), and provides goals to change behaviours in the short, medium, and long term. ASSISTi on follow‐up at 3 months CONTROL (n = 99) Randomly screened by ASSISTi or ASSISTc and received feedback about the score. Wait‐list – received MBIi after the study ended CO‐INTERVENTIONS: none |
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Outcomes |
Patients 1. ASSIST Total* (Men, Women) 2. ASSIST Alcohol (Men, Women) 3. ASSIST Marijuana (Men, Women) 4. ASSIST Other Drugs (Men, Women) 5. ASSIST Tobacco (Men, Women)# Carers Nil Process/health workers Nil Economic outcomes (and where these can be found, e.g. ref or table number) Nil (asterisk for study's primary outcomes; star: outcomes that we have not reported in this review) Time points: 3 months |
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Notes |
Source of funding: institutional (Universidade Federal do Paraná) support only Notes on validation of instruments (screening and outcomes): validated Additional information (e.g. provided by authors, existence of a published study protocol): declaration of interests ‐ all study authors reported no conflicts of interest Prospective trial registration number: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Judgement comment: Yen rated "unclear" and stated "random sequence generation is not described, apart from mentioning that each student received a personal code at time of enrolment"; Antonio rated "low" without comment. Final decision by Yen ‐ "unclear" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: Yen rated "unclear" and stated "allocation concealment is not described"; Antonio rated "low" without comment. Final decision by Yen "unclear" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Yen rated "high"; "subjects received the intervention and were thus not blinded to their intervention. Assessments were performed by an interviewer or were self‐assessed using computer software. Blinding was not performed" Antonio rated "unclear"; final decision by Yen ‐ "unclear" because although study design made it difficult to blind subjects to their intervention; this may have influenced the outcome as it is self‐assessed for some participants |
Blinding of outcome assessment (detection bias) all outcomes | High risk | Assessments were performed by an interviewer or were self‐assessed using computer software. Blinding was not performed |
Baseline outcome measurements similar | Low risk | Baseline total involvement, tobacco, alcohol, marijuana, and other drug ASSIST scores were statistically similar in all 3 groups |
Baseline characteristics similar? | Low risk | Randomisation successfully balanced intervention assignments and ensured equal characteristics in the groups (no signiciant differences; chi² test) |
Incomplete outcome data (attrition bias) Efficacy data | Unclear risk | Students: 458 students scored on ASSIST; 4 did not agree to participate in the RCT (1 in the ASSIST/MBIi group, 3 in the control group). Over the course of the trial, 121 students were lost (14%; i.e. not found after 3 attempts by phone or personal contact within 1 month after scheduled follow‐up) or dropped out (11%; i.e. when they personally or by phone/email gave up the study), for an overall response rate of 75%. Twenty‐three per cent of ASSIST/MBIc, 25% of ASSIST/MBIi, and 28% of control did not complete the 2 sessions, with no significant differences among groups Significant dropout rate (25%) in total ‐ this may have influenced results had these participants not dropped out |
Protection against contamination | Low risk | Judgement comment: both reviewers rated "low" |
Selective reporting (reporting bias) | Unclear risk | No published clinical trial protocol available; outcomes planned in methods section were reported in results section |
Other bias | Low risk | No other sources of bias were found |