Family-based intervention for families with parental mental illness
Official title: The VIA Family 2.0 Study: a Randomized Clinical Trial Evaluating Family-based Interventions for Children Born to Parents with Mental Disorders
Run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · NCT06312410 · Data updated 2026-11-12
This study is testing a new program to help families where one parent has a mental illness, to see if it can better support their children and prevent problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Years to 17 Years |
| Sex | All |
| Enrollment | 1452 (estimated) |
| Sponsor | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital Academic / other |
| Locations | 1 site (Copenhagen, Hellerup) |
| Status | Recruiting |
| Started | March 18, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | October 26, 2024 |
| Trial ID | NCT06312410 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include families with at least one parent diagnosed with a mental health disorder and a biological child under 18 living with them.
✕Probably not a fit
Patients who do not have a biological child living with them or whose mental health issues are not being actively treated may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The VIA Family 2.0 program is designed to support families where at least one parent has a mental illness, aiming to prevent negative outcomes for their children. This large randomized controlled trial will involve families living in the Capital Region and North Region of Denmark, focusing on early intervention strategies. The program seeks to address the unique challenges faced by children of parents with mental health issues, providing them with necessary support and resources. A detailed study protocol will be published in 2024 to outline the specific methodologies and interventions used.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and overall well-being of children living with parents who have mental illness.
How similar studies have gone: Other studies focusing on family-based interventions for children of parents with mental illness have shown promising results, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least one of the parents must be living in Capital Region or in Region North, Denmark, and at least one biological child under age 18 must be living with one of the parents. Only biological children of the parent with at mental health problem can be included. * The parent with the mental health problems has at some point been diagnosed in the secondary sector and has within the last three years been treated in the primary sector (GP or private psychiatric clinic) or in the secondary sector (hospital psychiatry). * Patients with substance abuse can only be included if substance abuse is a secondary diagnosis to another mental illness disorder being treated within the secondary sector during the last three years. * All adult participants must give informed consent. Both parents will need to consent in case of shared custody, but do not have to participate if they are reluctant to do so. Exclusion Criteria: * Not fulfilling inclusion criteria * Not giving informed consent * Living at Læsø or at Bornholm, Denmark * Children placed in care outside of the home fulltime in institution of professional family care (the family is not excluded if the children placed in part time in care outside home or fulltime family care within the family) * No risk factors found after baseline assessment (as described in the stepped care model) at baseline - these families can be re-referred if their situation changes. * Ongoing intensive family treatment in the municipality (for example staying at an institution for parental evaluation by the authorities)?
Where it's running
-
VIA Family 2.0 at BFOR, Gentofte Hospitalsvej 3A, Gentofte Hospital
Copenhagen, Hellerup, Denmark Recruiting
Study contacts
- Study coordinator: Anne A.E. Thorup, Professor
- Email: Anne.Amalie.Elgaard.Thorup@regionh.dk
- Phone: +4526210826
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.