VIA Family - A family-based early intervention versus treatment as usual for familial high-risk children: A study protocol for a randomized clinical trial

Background: Children born to parents with a severe mental illness, like schizophrenia, bipolar disorder, or major recurrent depression, have an increased risk of developing a mental illness themselves during life. These children are also more likely to have developmental delays, cognitive disabilities, or social problems, and they may have a higher risk than the background population of experiencing adverse life events. This is due to both genetic and environmental factors, but despite the well-documented increased risk for children with a familial high risk, no family-based early intervention has been developed for them. This study aims to investigate the effect of an early intervention that focuses on reducing risk and increasing resilience for children in families where at least one parent has a severe mental illness. Methods/design: The study is a randomized clinical trial with 100 children aged 6-12 with familial high risk. It is performed in the context of the Danish health-care system. Families will be recruited from registers or be referred from the primary sector or hospitals. The children and their parents will be assessed at baseline and thereafter randomized and allocated to either treatment as usual or VIA Family. The intervention group will be assigned to a multidisciplinary team of specialists from adult mental health services, child and adolescent mental health services, and social services. This team will provide the basic treatment elements: case management, psychoeducation for the whole family, parental training, a safety plan, and potentially an early intervention if the child has mental problems. The study period is 18 months for both groups, and all participants will be assessed at baseline and after 18 months. The primary outcome measure will be daily functioning of the child, and the secondary measures are the psychopathology of the child, days of absence from school, family functioning, child's home environment, and parental stress. Discussion: This study is to our knowledge the first to explore the effects of a multidisciplinary team intervention that provides an intensive and flexible support to match the families' needs for children with a familial high risk for severe mental illness. The study will provide important knowledge about the potential for increasing resilience and reducing risk for children by supporting the whole family. However, a longer follow-up period may be needed. Trial registration: ClinicalTrials.gov, NCT03497663. Registered on 13 April 2018.