Abstract
BackgroundParental mental illness is common and can lead to dependent children incurring a high risk of developing mental disorders, physical illness, and impaired educational and occupational outcomes. Family Talk is one of the better known interventions designed to prevent the intergenerational transmission of mental illness. However, its evidence base is small, with few robust independent randomised controlled trials, and no associated process or cost evaluations. The PRIMERA (Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children) research programme involves a mixed method evaluation of Family Talk which is being delivered in mental health settings in Ireland to improve child and family psychosocial functioning in families with parental mental illness.MethodsThe study comprises a multi-centre, randomised controlled trial (RCT), with nested economic and process evaluations, to assess the clinical and cost-effectiveness and implementation mechanisms of Family Talk compared to usual services. The study is being conducted in 15 adult and child mental health settings in Ireland. Families with a parent with mental illness, and children aged 5–18 years (n = 144 families) will be randomised to either the 7-session Family Talk programme (n = 96) or to standard care (n = 48) using a 2:1 allocation ratio. The primary outcomes are child psychosocial functioning and family functioning. Secondary outcomes are as follows: understanding and experience of parental mental illness, parental mental health, child and parental resilience, partner wellbeing and service utilisation. Blind assessments will take place at pre-intervention and at 6- and 12-month follow-up.DiscussionGiven the prevalence and burden of intergenerational mental illness, it is imperative that prevention through evidence-based interventions becomes a public health priority. The current study will provide an important contribution to the international evidence base for Family Talk whilst also helping to identify key implementation lessons in the scaling up of Family Talk, and other similar interventions, within routine mental health settings.Trial registrationISRCTN Registry, ISRCTN13365858. Registered 5th February 2019.
Highlights
Parental mental illness is common and can lead to dependent children incurring a high risk of developing mental disorders, physical illness, and impaired educational and occupational outcomes
Given the prevalence and burden of intergenerational mental illness, it is imperative that prevention through evidence-based interventions becomes a public health priority
The current study will provide an important contribution to the international evidence base for Family Talk whilst helping to identify key implementation lessons in the scaling up of Family Talk, and other similar interventions, within routine mental health settings
Summary
The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines [36] (Additional file 1). MMRM was chosen as the primary method for analysis as it can reduce several analytic problems that may arise within the current study It allows for different numbers of measurements per participant, thereby tolerating a level of missing data, which is problematic with RCTs with vulnerable populations, as follow-up data are often collected many months after treatment has ended and participants may be difficult to contact [59]. Written informed consent/assent will be obtained at each data collection time point (e.g. baseline, 6- and 12-month follow-ups, and if a parent/child is asked to participate in a qualitative interview). This will be available within 12 months of the trial end date
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