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. 2019 Dec 12;2019(12):CD001088. doi: 10.1002/14651858.CD001088.pub4

Barrowclough 2001.

Methods Allocation: randomised.
 Design: single‐centre (three sites).
 Duration: 12, 18* months.
Setting: own homes.
Location: Tameside & Glossop, Stockport and Oldham, UK.
Participants Diagnosis: ICD‐10 & DSM‐IV schizophrenia or schizoaffective disorder with DSM‐IV substance abuse or dependence.
 N = 36.
 Age: 18‐65 years, mean ˜ 31 years.
 Sex: 33 M, 3 F.
 Ethnicity: white European.
 Inclusion criteria: current substance abuse, in current contact with mental health services, min. 10 hours face‐to‐face contact with the caregiver per week, no organic brain disease or other serious medical illness or learning disability.
Interventions 1. Psychosocial intervention: MI with annualised individual CBT for the participant and CBT for family/caregiver for 9 months (plus routine care with family support worker). N = 18.
 2. Standard care: routine care plus family support worker. N = 18.
Outcomes Leaving the study early: lost to treatment, lost to evaluation.
 Adverse events: death.
 Mental state: PANSS, relapse: number of participants experiencing relapse.
 Global state: GAF.
 Social functioning: SFS.
Unable to use
 Substance use: ASI ‐ % days abstinent (no mean/SD).
 Mental state: PANSS (some data skewed).
 Relapse: duration of relapse (only median and range supplied).
 Other: SFS 18‐month (only adjusted means reported).
Notes Part ITT analysis.
*18‐month data (see secondary reference Haddock et al 2003).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated list stratified for sex and three types of substance use.
Allocation concealment (selection bias) Low risk Allocated by third party.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Clinician‐/participant‐mediated and participants and personnel not blinded. It is not possible to blind a psychosocial intervention.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Raters independent and blind so detection bias rated as low.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Lost to follow‐up: 22% (8/36) 18 months.
Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.
Selective reporting (reporting bias) Low risk No selective reporting evident between study protocol (N0244032344) and published article.
Other bias Low risk Funded by public institution (local health authorities). No evidence other bias occurring.