NCT06312410

The VIA Family 2.0 - a Family Based Intervention for Families with Parental Mental Illness

Recruiting now NA Last updated 26 October 2024

What this trial tests

NA trial testing VIA Family 2.0 in Child in 1,452 participants. Currently enrolling.

Timeline

18 March 2024

Primary endpoint
31 December 2027

31 December 2028

Quick facts

Lead sponsor	Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	1,452
Start date	18 March 2024
Primary completion	31 December 2027
Estimated completion	31 December 2028
Sites	1 location across Denmark

Drugs / interventions tested

• VIA Family 2.0

Conditions studied

• Child — all drugs for Child →
• Parents — all drugs for Parents →
• Mental Disorder — all drugs for Mental Disorder →
• Child of Impaired Parents — all drugs for Child of Impaired Parents →

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Who can join

Adults 0 to 17, any sex, with Child or Parents. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

VIA Family 2.0 - a Family Based Intervention for families with parental mental illness

Background: Children born to parents with mental illness have consistently been shown to have increased risks for a range of negative life outcomes including increased frequencies of mental disorders, somatic disorders, poorer cognitive functioning, social, emotional and behavioral problems and lower quality of life. Further these children are often overlooked by both society and mental health services, although they represent a potential for prevention and early intervention.

A collaboration between researchers and clinicians from two regions, the Capital Region and the North Region Denmark has been established as the Research Center for Family Based Interventions. The research center is an umbrella for a series of research activities, all focusing on children and adolescents in families with parental mental illness.

Method: A large randomized, controlled trial (RCT) for families with parental mental illness will be conducted in order to evaluate the effect of a two-year multidisciplinary, holistic team intervention (the VIA Family 2.0 team intervention) against treatment as usual (TAU). Inclusion criteria will be biological children 0-17 of parents with any mental disorder treated in the secondary sector at any time of their life and receiving treatment in primary or secondary sector within the previous three years. A total of 870 children or approx. 600 families will be included from two sites. Primary outcomes will be changes in child well being, parental stress, family functioning and quality of the home environment, .

Time plan: The RCT will start including families from March 1st, 2024 to Dec 2025 (or later if needed). All families will be assessed at baseline and at end of treatment, i.e. after 24 months and after 36 months. Baseline data will inform the intervention team about each family's needs, problems, and motivation. TAU will be similar in the two regions, which means three family meetings and option for children to participate in peer groups.

Challenges: final funding is being applied for. Recruitment of families can be challenging but we have decades of experience in conducting research in the field. Since both the target group, their potential problems and the intervention is complex, primary outcome is difficult to determine.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The VIA Family 2.0 study: a randomized clinical trial evaluating a family-based intervention for children born to parents with mental illnesses-study protocol.
   Heuckendorff S, Ranning A, Ingversen S, Vinding R, et al · · 2026 · PMID 42192567 · DOI 10.1186/s13063-026-09792-3