Mental Disorder
Conditions
Keywords
Familial high-risk children, preventive psychiatry, offspring
Brief summary
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: 1. Do children participating in the VIA Family intervention experience a greater decrease in symptoms of mental illness from baseline (timepoint 0) to long-term follow-up (timepoint 2) compared with children allocated to TAU? 2. Do parents participating in the VIA Family intervention experience a greater decrease in perceived parental stress from baseline (timepoint 0) to long-term follow-up (timepoint 2) compared with parents allocated to TAU?
Interventions
BEHAVIORALVIA Family
A family-based, multi-component, individual-tailored intervention based on case-management.
BEHAVIORALTreatment As Usual (TAU)
care as usual
Sponsors
TrygFonden, Denmark
Child and Adolescent Mental Health Services, Research Unit, Capital Region, Denmark
Mental Health Services in the Capital Region, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Strength and Difficulties Questionnaire (SDQ) | Change from baseline to 4 years follow-up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Family Assessment Device (FAD) | Change from baseline to 4 years follow-up | A 60 item parent report questionaire assesing family functioning ( scale 1-4. Low score represent better outcome) \[Time Frame: Change from baseline at 18 month follow-up\] |
| Change in Home Observation for Measurement of the Environment (HOME) | Change from baseline to 4 years follow-up | A clinican rated semi structured interview measuring stimulation and support in the home ( scale 0-60. High score represent better outcome) |
| Health-Related Quality of Life Questionnaire: KIDSCREEN -10 | Change from baseline to 4 years follow-up | A child-rated questionnaire on Healthrelated Quality of Life., 5-point Likert Scale, score range 10-50 ( higher score better quality of life) |
| Change in Children's Global Assessment Scale (CGAS) | Change from baseline to 4 years follow-up | A clinician rated measurment to asses general functioning in children (scale from 1-100. High score represent better outcome) |
| Parental Stress Scale (PSS) | Change from baseline to 4 years follow-up | A parent-rated questionnaire on the quality of experienced stress related to parenting, score 1-5, higher score more perceived parental stress |
| Personal and Social Performance Scale (PSP) | Change from baseline to 4 years follow-up | A clinician rated measurement to asses global functioning in parents, higher score indicates higher functioning |
| Parenting Scale (PS) | Change from baseline to 4 years follow-up | A parent-rated questionnaire on parenting (30items) Higher scores indicate dysfunctional parenting |
| This is Me (TIM) | Change from baseline to 4 years follow-up | A child-rated questionnaire on self-esteem,higher scores indicate better self-esteem |
Countries
Denmark
Outcome results
None listed