Actively Recruiting
The VIA Family 2.0 Study: a Randomized Clinical Trial Evaluating Family-based Interventions for Children Born to Parents with Mental Disorders
Led by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Updated on 2024-10-26
1452
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Lead Sponsor
A
Aalborg Psychiatric Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate a family-based intervention called VIA Family 2.0 for children born to parents with mental illness. The study addresses the increased risks these children face, such as mental and physical health issues, cognitive difficulties, and behavioral problems. It is a large randomized controlled trial comparing a two-year multidisciplinary, holistic team intervention against usual treatment in families from the Capital Region and North Region of Denmark. Families in the intervention group will work with a case manager who coordinates various support activities tailored to the children's ages and the family's needs. These include family-based psychoeducation, parenting support, peer groups, social counseling, and early assessment of children's mental health. The comparison group receives usual care involving a few family sessions and optional peer support groups for children. The intervention lasts for two years with assessments at baseline, 24 months, and a follow-up at 36 months. Participants will undergo several assessments measuring child well-being, parental stress, family functioning, and home environment quality using tools like the Strengths and Difficulties Questionnaire and the Family Assessment Device. These evaluations occur at multiple time points including baseline, during the intervention, and after completion. The study monitors family motivation and outcomes over three years to assess the impact of the intervention on these families' lives.
CONDITIONS
Brief Title
The VIA Family 2.0 - a Family Based Intervention for Families with Parental Mental Illness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least one parent living in Capital Region or Region North, Denmark
- At least one biological child under 18 living with the parent
- Parent has been diagnosed with a mental disorder and treated in primary or secondary care in the last 3 years
- Substance abuse as a secondary diagnosis is allowed if treated in secondary care within the last 3 years
- All adult participants must give informed consent; both parents must consent if they share custody
You will not qualify if you...
- Not meeting inclusion criteria
- Not giving informed consent
- Living in Læsø or Bornholm, Denmark
- Child placed full-time outside the home in an institution or professional family care
- No risk factors found after baseline assessment
- Ongoing intensive family treatment in the municipality, such as institutional parental evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants receive a family-based intervention coordinated by a case manager, including various supportive activities tailored to the family's needs and children's ages over a two-year period.
Ongoing activities coordinated by a case manager over 24 months
Duration - 12 months
Participants are assessed to evaluate the intervention's impact 12 months after the treatment period ends.
1 visit at 36 months post-baseline
Trial Site Locations
Total: 1 location
1
VIA Family 2.0 at BFOR, Gentofte Hospitalsvej 3A, Gentofte Hospital
Copenhagen, Hellerup, Denmark, 2900
Actively Recruiting
Research Team
A
Anne A.E. Thorup, Professor
S
Signe Heuckendorff, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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