NCT06312410 The VIA Family 2.0 - a Family Based Intervention for Families with Parental Mental Illness

Eligibility & Interventions

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This trial targets 1,452 participants in total. It began in 2024-03-18 with a primary completion date of 2027-12-31.

Brief 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.

Eligibility 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)?

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