Clinical trial NCT03497663: VIA Family - Family Based Early Intervention Versus Treatment as Usual
Official title: VIA Family - Family Based Early Intervention Versus Treatment as Usual. Study Protocol for a Randomized Clinical Trial. Can a Multidisciplinary Specialized Intervention Improve General Functioning and Decrease Symptoms of Psychopathology in Familial High Risk Children Born to Parents With Severe Mental Illness?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Intervention
Child of Impaired Parents
Child
Adolescent
Mental Disorders, Severe
Schizophrenia
Bipolar Disorder
Depressive Disorder, Recurrent
Psychotic Disorders
Parent-Child Relations
Keywords: Familial high risk
offspring
schizophrenia
bipolar disorder
recurrent depression
early intervention
parental training
family based intervention
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Municipality of Frederiksberg, Denmark
name: Ministry of the Interior and Health, Denmark
name: TrygFonden, Denmark
First posted: 2018-04-13
Enrollment: 96
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Child must have address registered in the municipality of Frederiksberg or Copenhagen.
* At least one of the biological parents must have a diagnosis of schizophrenia spectrum disorder, bipolar affective disorder or recurrent major depression.
* The parent with a diagnosis must have had at least one in- or outpatient contact with the mental health system within the lifetime of the child.

Exclusion Criteria:

* Parents who do not speak and understand enough Danish to be able to give informed consent for their own and for the child's participation.
* If all family members are currently engaged in an intensive family intervention program addressing parental functioning and child development, they are excluded from the study.

Primary outcomes:
measure: Change in Childrens Global Assesment Scale (CGAS)
timeFrame: Change from baseline at 18 month follow-up
Secondary outcomes:
measure: Change in Childrens Behaviour Checklist (CBCL)
timeFrame: Change from baseline at 18 month follow-up
measure: Change in Family Assessment Device (FAD)
timeFrame: Change from baseline at 18 month follow-up
measure: Change in child's number of days absent from school
timeFrame: Change from baseline at 18 month follow-up
measure: Change in Home Observation for Measurement of the Environment (HOME)
timeFrame: Change from baseline at 18 month follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Research Unit at Child and Adolescent Mental Health Center, Capital Region
Study officials:
affiliation: Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark
name: Anne Thorup
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller AD, Gjode ICT, Eigil MS, Busck H, Bonne M, Nordentoft M, Thorup AAE. VIA Family-a family-based early intervention versus treatment as usual for familial high-risk children: a study protocol for a randomized clinical trial. Trials. 2019 Feb 8;20(1):112. doi: 10.1186/s13063-019-3191-0.