VIA Family - Family Based Early Intervention Versus Treatment as Usual
Condition: Early Intervention; Child of Impaired Parents; Child; Adolescent; Mental Disorders, Severe; Schizophrenia; Bipolar Disorder; Depressive Disorder, Recurrent; Psychotic Disorders; Parent-Child Relations
MeSH terms: Schizophrenia; Depressive Disorder; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      This RCT aims to investigate the effect of an early family-based intervention (VIA Family)
      focusing on reducing risk and increasing resilience for children in families where at least
      one parent has a severe mental illness.The study is a randomized clinical trial including 100
      children age 6-12 with familial high risk.The children and their parents will be assessed at
      baseline and thereafter randomized and allocated to either Treatment as Usual or VIA Family.
    

Detailed description: 
      Background: Children born to parents with 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 display developmental delays,
      cognitive disabilities, social problems and may have a higher risk than background population
      of experiencing adverse life events. This is due to both genetic and environmental factors,
      but in spite of the well documented increased risk for children with familial high risk no
      family-based early intervention has been developed. This study aims to investigate the effect
      of an early intervention model focusing on reducing risk and increasing resilience for
      children in families where at least one parent has a severe mental illness.

      Methods: The study is a randomized clinical trial including 100 children age 6-12 with
      familial high risk. Families will be recruited from registers or be referred from the primary
      sector or from hospitals. The children and their parents will be assessed at baseline and
      thereafter randomized and allocated to either Treatment as Usual or VIA Family. In the VIA
      Family group the families will be offered regular contact with a case manager. A
      multidisciplinary team of specialists from Adult Mental Health Services, Child and Adolescent
      Mental Health Services and Social Services will be responsible for providing the basic
      treatment elements that are: case management, psychoeducation for the whole family, parental
      training (Triple P) and early intervention for mental problems of the child. The study period
      is 18 months for both groups and all participants will be assessed at baseline and after 18
      months. Primary outcome measure will be daily functioning of the child (CGAS), and secondary
      measures are psychopathology in the child and days of school absence, family functioning and
      child's home environment.

      Discussion: This study is to the investigators knowledge the first to explore the effects on
      children with familial high risk for severe mental illness of a multidisciplinary team
      intervention providing an intensive and flexible support matching the families' needs. The
      study will provide important knowledge about the possibilities of increasing resilience and
      reducing risk of a child by supporting the whole family. However, longer follow-up time may
      be needed.
    

Intervention name(s): VIA Family intervention; Treatment As Usual
Intervention type(s): Other; Other
Intervention description(s): Family based intervention; Treatment As Usual
Other intervention name(s): TAU
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The families randomly assigned to the VIA Family Group will be offered regular contact with a case manager. A multidisciplinary team of specialists from adult mental health services/psychiatry , child and adolescent mental health services and social services will be responsible for providing the basic treatment elements that are: case management, psychoeducation for the whole family, parental training (Triple P) and early intervention for mental problems of the child.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Familial high risk; offspring; schizophrenia; bipolar disorder; recurrent depression; early intervention; parental training; family based intervention