Abstract
BackgroundSevere mental illness (SMI), including schizophrenia, bipolar disorder and severe depression, is responsible for a substantial proportion of disability in the population. This article describes the aims and design of a research study that takes a novel approach to targeted prevention of SMI. It is based on the rationale that early developmental antecedents to SMI are likely to be more malleable than fully developed mood or psychotic disorders and that low-risk interventions targeting antecedents may reduce the risk of SMI.Methods/DesignFamilies Overcoming Risks and Building Opportunities for Well-being (FORBOW) is an accelerated cohort study that includes a large proportion of offspring of parents with SMI and embeds intervention trials in a cohort multiple randomized controlled trial (cmRCT) design. Antecedents are conditions of the individual that are distressing but not severely impairing, predict SMI with moderate-to-large effect sizes and precede the onset of SMI by at least several years. FORBOW focuses on the following antecedents: affective lability, anxiety, psychotic-like experiences, basic symptoms, sleep problems, somatic symptoms, cannabis use and cognitive delay. Enrolment of offspring over a broad age range (0 to 21 years) will allow researchers to draw conclusions on a longer developmental period from a study of shorter duration. Annual assessments cover a full range of psychopathology, cognitive abilities, eligibility criteria for interventions and outcomes. Pre-emptive early interventions (PEI) will include skill training for parents of younger children and courses in emotional well-being skills based on cognitive behavioural therapy for older children and youth. A sample enriched for familial risk of SMI will enhance statistical power for testing the efficacy of PEI.DiscussionFORBOW offers a platform for efficient and unbiased testing of interventions selected according to best available evidence. Since few differences exist between familial and ’sporadic’ SMI, the same interventions are likely to be effective in the general population. Comparison of short-term efficacy of PEI on antecedents and the long term efficacy for preventing the onset of SMI will provide an experimental test of the etiological role of antecedents in the development of SMI.Electronic supplementary materialThe online version of this article (doi:10.1186/s12888-014-0344-2) contains supplementary material, which is available to authorized users.
Highlights
Severe mental illness (SMI), including schizophrenia, bipolar disorder and severe depression, is responsible for a substantial proportion of disability in the population
Because the familial and environmental risk factors for mood and psychotic disorders largely overlap [5,6] and because early antecedents are less specific than prodrome [7], pre-emptive early interventions (PEI) may need to focus on broader categories, such as SMI, rather than a specific diagnosis
We propose that antecedents in combination with family history of SMI present an opportunity for developing and testing PEI at earlier stages of development than current ‘early interventions’
Summary
Ethical aspects FORBOW assessments involve safe established procedures and participation in FORBOW does not limit participants in accessing any type of care. It is essential to ensure confidentiality and minimize the risk of stigmatization (including self-stigmatization). We ask all parents and offspring who have the capacity to provide written consent after the study procedures are explained and written information is provided. We ask parents or guardians for written authorization for participation of offspring who may not have the capacity to provide consent. This includes consent to access electronic health-care related data through linkage with health card numbers, and consent to be contacted for additional research studies, including studies of interventions. Any feedback respects confidentiality of individual participants: information provided by offspring is not disclosed to parents unless such disclosure is necessary to prevent significant harm.
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