Falloon 1982.
Methods | Allocation: randomised.
Blindness: medication prescriber blind to treatment group, some outcome assessments blind.
Duration: 2 years. Design: parallel. Setting: outpatients. Country: USA. |
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Participants | Diagnosis: schizophrenia (DSM‐III).
N = 39.
Age: mean˜26 years, range 18‐41 years.
Sex: 26M, 13F. History: definite diagnosis of schizophrenia according to PSE, residence or close daily contact with one or both biological parents, and use of English as primary language in the home. Exclusions: < 18 or > 45 years old, |
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Interventions | 1. Individual supportive therapy: dose weekly for 3 months, fortnightly for 6 months, then monthly. N = 19. 2. Family treatment approach: dose weekly for 3 months, fortnightly for 6 months, then monthly. N = 20. | |
Outcomes | Global state: relapse, remission.
Service outcomes: hospitalisation.
Leaving the study early.
General functioning: paid for work, admission to residential placement, admission to jail.
Behaviour: SBAS, coping style.
Engagement with services: poor attendance at appointments. Complicance: poor compliance to therapy Medication: prescribed IM depot medication. Unable to use ‐ Service outcomes: average number of days in hospital (SDs not reported). Mental state: Hopkins' Symptom Checklist (data not reported), target symptom rating (scale not peer‐reviewed), episode of depression (data not reported). General functioning: problem solving score (no SDs reported), change in work and social status (means and SDs not reported), SAS‐SR (means and SDs not reported), knowledge about schizophrenia (scale not peer‐reviewed). Family coping score (no SDs reported). Antipsychotic drug dose (no SDs reported), antipsychotic drug plasma level (data not reported), co‐efficient of variation in plasma drug level/prescribed dose ratio (data not reported). Economic outcomes: direct costs (data not reported), indirect costs (data not reported). |
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Notes | Percentage of participants for whom no outcome data is available at 2 years: 1. Supportive psychotherapy 11%. 2. Family therapy 15%. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Randomized”, no further details reported. |
Allocation concealment (selection bias) | Unclear risk | No information reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "All patients were seen monthly at the clinic by a research psychiatrist or a clinical pharmacist, who was blinded to the type of treatment and responsible for managing the pharmacologic aspects of treatment." No details reported about other staff. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes either self‐assessments or by blinded assessors. “The raters were the prescribing doctors who were blinded to the assignment to treatment." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | “Two patients receiving family therapy and one receiving individual therapy withdrew from the study in the early stages of treatment”. Patients who withdrew were not analysed for any outcome. Losses to follow‐up or missing data balanced across intervention groups, with similar reasons for missing data. |
Selective reporting (reporting bias) | High risk | Reports results incompletely, data not reported for Hopkins' Symptom Checklist and episode of depression, SDs not reported for average number of days in hospital. |
Other bias | Low risk | Funded by an NIH grant. |