Actively Recruiting

Phase Not Applicable
Age: 0Years - 17Years
All Genders
NCT06312410

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

Led by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Updated on 2024-10-26

1452

Participants Needed

1

Research Sites

249 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least one parent must live in the Capital Region or Region North, Denmark, with a biological child under 18 living with them
  • The parent with mental health problems must have been diagnosed in secondary care and treated in primary or secondary care within the last three years
  • Patients with substance abuse can join only if substance abuse is a secondary diagnosis to another mental disorder treated in secondary care in the last three years
  • All adult participants must provide informed consent; both parents must consent if there is shared custody, though both do not need to participate
Not Eligible

You will not qualify if you...

  • Not meeting the inclusion criteria
  • Not providing informed consent
  • Living in Læsø or Bornholm, Denmark
  • Children placed fulltime in institutional or professional family care outside the home; part-time or fulltime family care within the family is allowed
  • No risk factors identified after baseline assessment; these families can be re-referred if situations change
  • Receiving ongoing intensive family treatment from municipal authorities (e.g., staying at an institution for parental evaluation)

AI-Screening

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Trial Site Locations

Total: 1 location

1

VIA Family 2.0 at BFOR, Gentofte Hospitalsvej 3A, Gentofte Hospital

Copenhagen, Hellerup, Denmark, 2900

Actively Recruiting

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Research Team

A

Anne A.E. Thorup, Professor

CONTACT

S

Signe Heuckendorff, PhD

CONTACT

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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