The VIA Family 2.0 study: a randomized clinical trial evaluating a family-based intervention for children born to parents with mental illnesses–study protocol

BACKGROUND: Children of parents with mental illness face significant increased risks of developing mental health problems and experiencing developmental delays or other negative life outcomes due to genetic and environmental factors. Parental symptoms often disrupt caregiving, leading to family stress, inadequate routines, and insufficient stimulation and support in the home. Research, including findings from the Danish High Risk and Resilience Study, the VIA cohort, has shown substantial developmental, social, and cognitive challenges in these children. This study aims to evaluate the efficacy of a team-based, multidisciplinary preventive intervention compared with standard treatment for families with recent parental mental illness via a series of predefined outcome measures. METHODS/DESIGN: This randomized controlled trial, VIA Family 2.0, includes 304 children aged 3-17 years and 128 children aged 0-2 years with a parent with a psychiatric diagnosis and having received treatment within the past three years. The families will be assessed at baseline and thereafter randomized to either treatment as usual or VIA Family 2.0 intervention. The intervention group will be assigned to a multidisciplinary team with expertise from municipal services, child and adolescent psychiatry, and adult psychiatry. A case manager coordinates all the elements and supports the family with their challenges, on the basis of their own motivation. The study period is 24 months, and all participants will be assessed at baseline and after 24 months. The primary outcomes are cognitive, language and motor development for infants and toddlers aged 0-2 years (Bayley-4, Bayley Scales of Infant and Toddler Development), well-being and behavioral and social development for children aged 3-17 years (the Strengths and Difficulties Questionnaire (SDQ)), perceived parental stress for parents (Parental Stress Scale, PSS), and family functioning for the family (Family Assessment Device, FAD). DISCUSSION: This study examines the impact of a cross-sectoral intervention that integrates expertise across sectors. This study contributes critical knowledge about whether improving family resilience, supporting children's development, and reducing risk loads through holistic family support is possible. This research highlights the potential of preventive public health initiatives to promote well-being and reduce long-term adverse outcomes in a high-risk group of children and adolescents. TRIAL REGISTRATION: The study is registered at ClinicalTrials.Gov (NCT06312410) on March 15, 2024.