Clinical trial NCT06312410: The VIA Family 2.0 - a 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child
Parents
Mental Disorder
Child of Impaired Parents
Preventive Health Services
Keywords: family based intervention
early intervention
familial high risk
COPMI - children of parents with mental illness
parental mental illness
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Aalborg Psychiatric Hospital
name: TrygFonden, Denmark
name: Novo Nordisk A/S
name: Lundbeck Foundation
name: Liljeborgfonden
name: Ebbefos Fonden
name: KV Fonden
First posted: 2024-03-15
Enrollment: 1452
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: A detailed study protocol will be published in 2024

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)?

Primary outcomes:
measure: Change in Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: Change in Bayley-4 Bayley Scales Test for Infant and Toddler Development
timeFrame: Baseline, after 6 months, after 12 months, after 18 months and after 24 months.
measure: Change in Family Assessment Device - General Function Scale (FAD-GF)
timeFrame: Baseline, end of intervention (24 months), and 36 months follow up
measure: Change in Parental Stress Scale (PSS)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
Secondary outcomes:
measure: Change in Home Observation for Measurement of the Environment (HOME)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: Change in Parenting and Family Adjustment Scales (PAFAS)
timeFrame: Baseline, end of intervention (24 months), and 36 months follow up
measure: Change in Children's Global Assessment Scale (CGAS)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up
measure: Change in Perceived Stress Scale (PSS)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: Client Satisfaction Scale (CSQ)
timeFrame: End of intervention (24 months)
Other outcomes:
measure: Change in Ages and Stages Questionnaire:SE-2 (ASQ-SE)
timeFrame: Baseline, after 6 months, after 12 months, after 18 months, after 24 months and 36 months (for children aged 3-5 years)
measure: Change in Daily Life Stressor Scale (DLSS)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: Change in Child and Youth Resilience Measure (CYRM-R)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: Alarm Distress Baby Scale (ADBB)
timeFrame: Baseline, after 6 month (for children age 0-2 years), after 12 month, after 18 months, after 24 months), and 36 months follow up
measure: Change in Personal and Social Performance Scale (PSP)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: Change in Global Assessment of Function - Symptoms (GAF-S)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: Change in Kessler Psychological Distress Scale, K10
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: Change in General Self-Efficacy Scale (GSE)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: Change in Social Provision Scale-short form (SPS)
timeFrame: Baseline, end of intervention (24 months), and 36 months follow up
measure: Change in Quality-adjusted life year (EQ-5D)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: Change in Self-Stigma of Mental Illness Scale - short form (SSMIS-SF)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: Change in The Questionnaire about the Process of Recovery (QPR)
timeFrame: Baseline, end of intervention (24 months) and 36 months follow up.
measure: General Intelligence Test (RIST)
timeFrame: Baseline
Locations:
city: Copenhagen
country: Denmark
facility: VIA Family 2.0 at BFOR, Gentofte Hospitalsvej 3A, Gentofte Hospital
state: Hellerup
Study officials:
References: