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.
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.
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)
Parallel
VIA Family 2.0
Other interventionMultidisciplinary team based preventive intervention. For details, please see arm/group description.
Change in Strengths and Difficulties Questionnaire (SDQ)
Primary outcome for children/adolescents aged 3 years to 17 years will be child's development and wellbeing measured by Strengths and Difficulties Questionnaire (SDQ), which has been used in several other studies, is easy to complete, has Danish norms and is a part of the diagnostic evaluation, Development and Well-Being Assessment, (DAWBA), will be used for psychopathology assessment as well, and can be filled in digitally by the primary caregiver before the clinical assessment. The higher score, the more problems Rated by child from age 11 and by always by parent. A 25 item self-report questionnaire assessing developmental, behavioural and emotional problems completed by children aged 11-17. Items are rated on a three-point Likert scale (0= not true, 1= somewhat true, 2= certainly true).
Change in Bayley-4 Bayley Scales Test for Infant and Toddler Development
The primary outcome for the youngest children aged 0-2 years will be scores from Bayley-4, a clinical test of the child's cognitive, language, motor and emotional development, conducted by a trained researcher. Scores range from 1-19, the higher score the better functioning
Change in Family Assessment Device - General Function Scale (FAD-GF)
Primary outcome for the whole family is family functioning rated by the primary caregiver. Family function will be measured by the questionnaire Family Assessment Device, a 12 item questionnaire by the parents and children from age 12 Scale from 1-4. Low score represents better outcome.
Change in Parental Stress Scale (PSS)
The primary outcome for the parents is parental stress measured by the Parental Stress Scale (PSS), which is a 18 item parent-reported questionnaire on the quality of experienced stress related to parenting. Score 1-5. A higher score indicates more parental stress.
Change in Home Observation for Measurement of the Environment (HOME)
A clinician rated semi-structured interview with both caregiver and child measuring stimulation and support in the home environment (scale 0-60/62 dep on age versions). Higher score represents better outcome.
Change in Parenting and Family Adjustment Scales (PAFAS)
30 item questionnaire assessing changes in parenting practices, parental adjustment, and family relationships. Scores from 0-90, higher scores indicates poorer parenting or adaptation
Change in Children's Global Assessment Scale (CGAS)
A clinical rated measurement based on interview to assess general functioning in children. Information is obtained from the child and the caregiver, separately. Scale from 1-100. Higher score indicates better functioning.
Change in Perceived Stress Scale (PSS)
10 item questionnaire measuring perceived stress (parents)
Change in Ages and Stages Questionnaire:SE-2 (ASQ-SE)
Questionnaire measuring child social and emotional development and milestones. Scores range from 0-465, higher scores above cut-off (59) indicate social and emotional problems.
Change in Daily Life Stressor Scale (DLSS)
14 item questionnaire measuring child stress, scores range from 0-56, the higher score the higher level of perceived stress
Change in Child and Youth Resilience Measure (CYRM-R)
A 12 item self-report questionnaire from age 5 assessing resiliency in children across a number of areas including personal skills, peer support, social skills, physical and psychological caregiving, educational and cultural. Items are rated on a 3- or 5-point Likert scale. Higher scores indicating greater resiliency.
Alarm Distress Baby Scale (ADBB)
Test for children aged 2-24 months measuring social withdrawal, scores range from 0-32, scores above 4 indicate social withdrawal, the higher score the more severe
Click on the lead sponsor to view all of their trials.
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Lead sponsor
Aalborg Psychiatric Hospital
Collaborator
TrygFonden, Denmark
Collaborator
Novo Nordisk A/S
Collaborator
Lundbeck Foundation
Collaborator
Liljeborgfonden
Collaborator
Ebbefos Fonden
Collaborator
KV Fonden
Collaborator
