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Background: This study assessed the efficacy of the Falloon model of psychoeducational family intervention (PFI), originally developed for schizophrenia management and adapted to bipolar I disorder. The efficacy of the intervention was evaluated in terms of improvement of patients׳ social functioning and reduction of family burden., Methods: This was a multicentre, real-world, controlled, outpatient trial carried out in 11 randomly recruited Italian mental health centres. Enroled patients and key-relatives were consecutively allocated either to receive PFI and Treatment As Usual (TAU) or to a waiting list receiving TAU alone. The efficacy of the intervention was evaluated in terms of improvement in patients׳ social functioning (primary outcome) and reduction of family burden (secondary outcome)., Results: Of the 137 recruited families, 70 were allocated to the experimental group and 67 to the control group. At the end of the intervention, significant improvements in patients׳ social functioning and in relatives׳ burden were found in the treated group compared to TAU. This effect of the intervention remained also after controlling for several confounding patient׳s socio-demographic and clinical factors. The experimental intervention had an impact also on other outcome measures, such as patients׳ clinical status and personal burden., Limitations: Lack of an active control group., Conclusions: The results of this study clearly show that the psychoeducational family intervention according to the Falloon model is effective in improving the social outcome of patients with bipolar I disorder., (Copyright © 2014 Elsevier B.V. All rights reserved.)