Kemp 2007.
Methods | Allocation: randomised.
Design: single‐centre.
Duration: 6 months.
Setting: community based early intervention programme. Location: Western Sydney, NSW, Australia. |
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Participants | Diagnosis: DSM‐IV psychotic illness and current alcohol or cannabis use based on AUDIT or DAST scores.
N = 19.
Age: mean ˜ 21 years, range 17‐25 years.
Sex: 13 M, 3 F (3, Unknown). Ethnicity: not stated. Inclusion criteria: young English speaking, living within the area health sector and not homeless. |
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Interventions |
1. Psychosocial intervention: MI + CBT, Stop using stuff (SUS) manualised 4‐6 hours. N = 10. 2. Standard care: TAU, standard care included case management and has a significant focus on substance reduction. N = 9. |
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Outcomes | Leaving the study early: lost to evaluation. Mental state: PANSS total. Unable to use Mental State: DASS (some data skewed). Substance use: AUDIT, DAST‐10 frequency and quantity of cannabis or alcohol use (skewed data). |
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Notes | Authors have kindly provided additional data. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised, cards were shuffled, numbered and placed in sealed envelopes. |
Allocation concealment (selection bias) | Unclear risk | Numbered sealed envelopes with the allocation placed into a box by a third person. Envelopes were then drawn in order from the box each time a patient was randomised. Unclear whether envelopes were opaque. |
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 | High risk | Measures that were clinician‐rated were all performed by the clinician providing the treatment and were therefore not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Lost to follow‐up: 16% (3/19) 6 months. Three patients dropped out of the TAU group, no explanation was given. No ITT analysis. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement of 'yes' or 'no' as no protocol was available. |
Other bias | Unclear risk | Had extreme baseline imbalance in substance use (AUDIT), DASS and self‐efficacy score. This could be due to low subject numbers recruited for study. |