Mental Disorder Clinical Trial
Official title:
VIA Family - Family Based Early Intervention Versus Treatment as Usual- 4 Year Follow-up
Verified date | April 2024 |
Source | Mental Health Services in the Capital Region, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 113 |
Est. completion date | January 30, 2024 |
Est. primary completion date | January 30, 2024 |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark | Hellerup |
Lead Sponsor | Collaborator |
---|---|
Mental Health Services in the Capital Region, Denmark | Child and Adolescent Mental Health Services, Research Unit, Capital Region, Denmark, TrygFonden, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change from baseline to 4 years follow-up | |
Secondary | 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) | Change from baseline to 4 years 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) [Time Frame: Change from baseline at 18 month follow-up] | Change from baseline to 4 years 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 to 4 years follow-up | |
Secondary | 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) | Change from baseline to 4 years follow-up | |
Secondary | This is Me (TIM) | A child-rated questionnaire on self-esteem,higher scores indicate better self-esteem | Change from baseline to 4 years follow-up | |
Secondary | 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 | Change from baseline to 4 years follow-up | |
Secondary | Personal and Social Performance Scale (PSP) | A clinician rated measurement to asses global functioning in parents, higher score indicates higher functioning | Change from baseline to 4 years follow-up | |
Secondary | Parenting Scale (PS) | A parent-rated questionnaire on parenting (30items) Higher scores indicate dysfunctional parenting | Change from baseline to 4 years follow-up |
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