Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
100

Summary

Conditions
  • Adolescent
  • Bipolar Disorder
  • Child
  • Child of Impaired Parents
  • Depressive Disorder, Recurrent
  • Early Intervention
  • Mental Disorders, Severe
  • Parent-Child Relations
  • Psychotic Disorders
  • Schizophrenia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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)Masking Description: Baseline AssessorPrimary Purpose: Treatment

Participation Requirements

Age
Between 6 years and 12 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT03497663
Collaborators
  • Municipality of Frederiksberg, Denmark
  • Ministry of the Interior and Health, Denmark
  • TrygFonden, Denmark
Investigators
Principal Investigator: Anne Thorup Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark