An interventional study of VIA Family and Treatment As Usual (TAU) in Mental Disorder, sponsored by Mental Health Services in the Capital Region, Denmark. Completed at 1 site in Denmark. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Mental Health Services in the Capital Region, Denmark · Not applicable, Interventional, and Prevention
This study aims to investigate the long-term effects (2.5 years after post-intervention) of a preventive family-based intervention (VIA Family) compared with treatment as usual (TAU) for children of parents with a severe mental illness.
Background:
Children of parents with a mental illness have an increased lifetime risk of developing a mental illness themselves. Preventive interventions for families with children with high familial risk can potentially disrupt the transgenerational transmission.
The current study is a follow-up study of a trial investigating the effect of the preventive intervention: the VIA Family trial.
The VIA Family trial investigated the superiority of a preventive family-based intervention, VIA Family, compared with treatment as usual (TAU) in improving children's, parents' and families' functioning and well-being. Eligible families had at least one parent with a lifetime severe mental illness diagnosis ( i.e. recurrent major or moderate depression, bipolar disorder, or schizophrenia spectrum disorder), at least one child between the ages of 6-12 years and lived within the Frederiksberg or Copenhagen (Denmark). The trial had a randomized, two-armed, parallel and controlled design. The participating families were randomly assigned to both groups with an allocation ratio of 1:1.
The current study is a follow-up study aiming to explore the effect of the intervention 2.5 years after post-intervention.
The main research questions for the current follow-up study are:
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's enrollment of 113 is above the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Mental Health Services in the Capital Region, Denmark is the lead sponsor of 51 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: VIA Family
TAU is defined as any kind of help and support focusing on high risk children and parental mental illness within the catchment area of the study. 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.
Behavioral: Treatment As Usual (TAU)
A family-based, multi-component, individual-tailored intervention based on case-management.
care as usual
Change in "Strength and Difficulties Questionnaire" (SDQ)
Parent reported 25-items questionaire of their child's behavioural and emotional difficulties, 3-point Likert scale (0,1,2), higher scores indicate more emotional or behavioral problems
Time frame: Change from baseline to 4 years follow-up
Change in Children's Global Assessment Scale (CGAS)
A clinician rated measurment to asses general functioning in children (scale from 1-100. High score represent better outcome)
Time frame: Change from baseline to 4 years follow-up
Change in Family Assessment Device (FAD)
A 60 item parent report questionaire assesing family functioning ( scale 1-4. Low score represent better outcome) \[Time Frame: Change from baseline at 18 month follow-up\]
Time frame: Change from baseline to 4 years follow-up
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)
Time frame: Change from baseline to 4 years follow-up
Health-Related Quality of Life Questionnaire: KIDSCREEN -10
A child-rated questionnaire on Healthrelated Quality of Life., 5-point Likert Scale, score range 10-50 ( higher score better quality of life)
Time frame: Change from baseline to 4 years follow-up
This is Me (TIM)
A child-rated questionnaire on self-esteem,higher scores indicate better self-esteem
Time frame: Change from baseline to 4 years follow-up
Parental Stress Scale (PSS)
A parent-rated questionnaire on the quality of experienced stress related to parenting, score 1-5, higher score more perceived parental stress
Time frame: Change from baseline to 4 years follow-up
Personal and Social Performance Scale (PSP)
A clinician rated measurement to asses global functioning in parents, higher score indicates higher functioning
Time frame: Change from baseline to 4 years follow-up
Parenting Scale (PS)
A parent-rated questionnaire on parenting (30items) Higher scores indicate dysfunctional parenting
Time frame: Change from baseline to 4 years follow-up
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Mental Health Services in the Capital Region, Denmark