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VIA Family - Family Based Early Intervention Versus Treatment as Usual

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ClinicalTrials.gov Identifier: NCT03497663
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborators:
Municipality of Frederiksberg, Denmark
Ministry of the Interior and Health, Denmark
TrygFonden, Denmark
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

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.

Condition or disease Intervention/treatment Phase
Early Intervention Child of Impaired Parents Child Adolescent Mental Disorders, Severe Schizophrenia Bipolar Disorder Depressive Disorder, Recurrent Psychotic Disorders Parent-Child Relations Other: VIA Family intervention Other: Treatment As Usual Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
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)
Masking Description: Baseline Assessor
Primary Purpose: Treatment
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?
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


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 Name: TAU




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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).

  2. 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)

  3. 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.

  4. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497663


Locations
Denmark
Research Unit at Child and Adolescent Mental Health Center, Capital Region
Copenhagen, Denmark
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT03497663     History of Changes
Other Study ID Numbers: VIAFAMILYFEB18
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mental Health Services in the Capital Region, Denmark:
Familial high risk
offspring
schizophrenia
bipolar disorder
recurrent depression
early intervention
parental training
family based intervention

Additional relevant MeSH terms:
Disease
Schizophrenia
Depressive Disorder
Depression
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mood Disorders
Behavioral Symptoms
Bipolar and Related Disorders