VIA Family - Family Based Early Intervention Versus Treatment as Usual

March 15, 2023 updated by: Mental Health Services in the Capital Region, Denmark

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?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Research Unit at Child and Adolescent Mental Health Center, Capital Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VIA Family intervention
VIA Family is a family based intervention. 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 and regular contact with the case manager, psychoeducation for the whole family, parental training (Triple P) and early intervention for mental problems of the child.
Other: VIA Family intervention
Family based intervention
Active Comparator: Treatment as Usual (TAU)
TAU is defined as any kind of help and support focusing on high risk children and parental mental illness. At present, the municipalities and the mental health services do not offer any kind of family focused intervention addressing parental mental illness that can be compared to the VIA Family program.
Other: Treatment As Usual
Treatment As Usual
Other Names:
  • TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Childrens Global Assesment Scale (CGAS)
Time Frame: Change from baseline at 18 month follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Childrens Behaviour Checklist (CBCL)
Time Frame: Change from baseline at 18 month follow-up
Parent and teacher reported questionaire on child behavior ( low score represent better outcome).
Change from baseline at 18 month follow-up
Change in Family Assessment Device (FAD)
Time Frame: Change from baseline at 18 month follow-up
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
Change in child's number of days absent from school
Time Frame: Change from baseline at 18 month follow-up
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
Change in Home Observation for Measurement of the Environment (HOME)
Time Frame: Change from baseline at 18 month follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mental Health Services in the Capital Region, Denmark

Collaborators

TrygFonden, Denmark
Ministry of the Interior and Health, Denmark
Municipality of Frederiksberg, Denmark

Investigators

  • Principal Investigator: Anne Thorup, Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2017

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIAFAMILYFEB18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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