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

Child Clinical Trial

Official title: The VIA Family 2.0 Study: a Randomized Clinical Trial Evaluating Family-based Interventions for Children Born to Parents With Mental Disorders

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

A detailed study protocol will be published in 2024 ;

Related Conditions & MeSH terms

• Child
• Child of Impaired Parents
• Mental Disorder
• Mental Disorders
• Parents
• Preventive Health Services
• Psychotic Disorders

• NCT number: NCT06312410
• Study type: Interventional
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Anne A.E. Thorup, Professor
• Phone: +4526210826
• Email: Anne.Amalie.Elgaard.Thorup@regionh.dk
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 18, 2024
• Completion date: December 31, 2028