VIA Family - Family Based Early Intervention Versus Treatment as Usual

Schizophrenia Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497663
• Other study ID #: VIAFAMILYFEB18
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: January 1, 2021

Study information

• Verified date: October 2020
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent
• Bipolar Disorder
• Child
• Child of Impaired Parents
• Depressive Disorder
• Depressive Disorder, Recurrent
• Disease
• Early Intervention
• Mental Disorders
• Mental Disorders, Severe
• Parent-Child Relations
• Psychotic Disorders
• Schizophrenia

Intervention

Other:
• VIA Family intervention
Family based intervention
• Treatment As Usual
Treatment As Usual

Locations

Country	Name	City	State
Denmark	Research Unit at Child and Adolescent Mental Health Center, Capital Region	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Ministry of the Interior and Health, Denmark, Municipality of Frederiksberg, Denmark, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Childrens Global Assesment Scale (CGAS)	A clinician rated measurment to asses general functioning in children (scale from 1-100. High score represent better outcome)	Change from baseline at 18 month follow-up
Secondary	Change in Childrens Behaviour Checklist (CBCL)	Parent and teacher reported questionaire on child behavior ( low score represent better outcome).	Change from baseline at 18 month follow-up
Secondary	Change in Family Assessment Device (FAD)	A 60 item parent report questionaire assesing family functioning ( scale 1-4. Low score represent better outcome)	Change from baseline at 18 month follow-up
Secondary	Change in child's number of days absent from school	Number of days child was absent from school within the last 6 month (low number represent better outcome). Teacher rated.	Change from baseline at 18 month follow-up
Secondary	Change in Home Observation for Measurement of the Environment (HOME)	A clinican rated semi structured interview measuring stimulation and support in the home ( scale 0-60. High score represent better outcome)	Change from baseline at 18 month follow-up