VIA Family 4 Year Follow-up of a Family-based Preventive Intervention
- Conditions
- Mental Disorder
- Registration Number
- NCT06218693
- Lead Sponsor
- Mental Health Services in the Capital Region, Denmark
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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
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)
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)
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
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
Parenting Scale (PS) Change from baseline to 4 years follow-up A parent-rated questionnaire on parenting (30items) Higher scores indicate dysfunctional parenting
Trial Locations
- Locations (1)
Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark
🇩🇰Hellerup, Denmark
Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark🇩🇰Hellerup, Denmark