ChildNCT06312410
The VIA Family 2.0 - a Family Based Intervention for Families with Parental Mental Illness
A study testing VIA Family 2.0 in people with Child and Parents, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Child, Parents, Mental Disorder
- What is being tested?
- VIA Family 2.0
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,452 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Mar 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)?
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
VIA Family 2.0 at BFOR, Gentofte Hospitalsvej 3A, Gentofte Hospital
Copenhagen, Hellerup, 2900
Anne Thorup, Phd, +4526210826, anne.amalie.elgaard.thorup@regionh.dk
Rikke Vinding, MS, rikke.vinding@regionh.dk
About this study
Official title: The VIA Family 2.0 Study: a Randomized Clinical Trial Evaluating Family-based Interventions for Children Born to Parents with Mental Disorders
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.
Read more
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.
Read the detailed description
A detailed study protocol will be published in 2024
- Being tested
- VIA Family 2.0
- Keywords
- family based intervention, early intervention, familial high risk, COPMI - children of parents with mental illness, parental mental illness
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIA Family 2.0Other
Multidisciplinary team based preventive intervention. For details, please see arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| VIA Family 2.0 | Experimental | In the intervention all child-involving elements are adapted to the specific age groups of the children, but everything is built on the same basic multidisciplinary, holistic and cross-sectional team model.
Every family will be affiliated to a case manager, who will coordinate all activities and appointments and be available throughout the intervention period of two years. A range of intervention elements will be offered to the family, depending on age of the child(ren), the family's needs and will always rely on their motivation:
* Case-management supporting to reach good family functioning
* Family-based psychoeducation
* Parents' and children's groups with integrated peer-support
* Parenting support and training
* Mapping and nurturing of resources in the social network and social counseling
* Early assessment of children's possible mental health problems
* All elements will be adapted to the age of the children (details available upon request) Receives: Other: VIA Family 2.0 |
| Treatment as usual (TAU) | Active comparator | TAU varies to some extent in the two regions, but common is that it consists of 2-3 family consultations (family sessions) with the presence of parents and all children above the age of six years.
These consultations will be managed by the Center for Relatives in the North Denmark Region and by the clinical 'child key persons' , who are staff with a special training in children and family impact in all departments of mental health services in the Capital Region.
The child is also referred to participate in a psychoeducational group for same aged children. Children can participate in a group with peers, who have a parent with a mental illness as well. These groups are run by two therapists with many years of experience working with groups like this for different age groups. Participation in groups like this is voluntary, and not all children continue in a group after the family consultations. Receives: Other: VIA Family 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, end of intervention (24 months) and 36 months follow up.
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
Measured: Baseline, after 6 months, after 12 months, after 18 months and after 24 months.
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.
Measured: Baseline, end of intervention (24 months), and 36 months follow up
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.
Measured: Baseline, end of intervention (24 months) and 36 months follow up.
Secondary outcomes (5)
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.
Measured: Baseline, end of intervention (24 months) and 36 months follow up.
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
Measured: Baseline, end of intervention (24 months), and 36 months follow up
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.
Measured: Baseline, end of intervention (24 months) and 36 months follow up
Change in Perceived Stress Scale (PSS)
10 item questionnaire measuring perceived stress (parents)
Measured: Baseline, end of intervention (24 months) and 36 months follow up.
Client Satisfaction Scale (CSQ)
Questionnaire with 8 items measuring patient/client .Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Measured: End of intervention (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start18 Mar 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg Psychiatric Hospital, TrygFonden, Denmark, Novo Nordisk A/S, Lundbeck Foundation, Liljeborgfonden, Ebbefos Fonden, KV Fonden
- Responsible party
- Principal investigator, Anne Amalie Elgaard Thorup, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312410
- Sponsor's protocol ID
- H-23067714
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heuckendorff S, Ranning A, Ingversen S, Vinding R, Bars EM, Forman J, Muller AD, Hjorthoj C, Moszkowicz M, Kristensen JS, Lauritsen MB, Sandberg J, Eplov LF, Nordentoft M, Thorup AAE. The VIA Family 2.0 study: a randomized clinical trial evaluating a family-based intervention for children born to parents with mental illnesses-study protocol. Trials. 2026 May 27;27(1):509. doi: 10.1186/s13063-026-09792-3.
PubMed 42192567
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VIA Family 2.0 Study: a Randomized Clinical Trial Evaluating Family-based Interventions for Children Born to Parents with Mental Disorders
- ClinicalTrials.gov ID
- NCT06312410
- Acronym / sponsor ID
- H-23067714
- Keywords
- family based intervention, early intervention, familial high risk, COPMI - children of parents with mental illness, parental mental illness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,452 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Aalborg Psychiatric Hospital, TrygFonden, Denmark, Novo Nordisk A/S, Lundbeck Foundation, Liljeborgfonden, Ebbefos Fonden, KV Fonden
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIA Family 2.0 | Experimental | Other: VIA Family 2.0In the intervention all child-involving elements are adapted to the specific age groups of the children, but everything is built on the same basic multidisciplinary, holistic and cross-sectional team model. Every family will be affiliated to a case manager, who will coordinate all activities and appointments and be available throughout the intervention period of two years. A range of intervention elements will be offered to the family, depending on age of the child(ren), the family's needs and will always rely on their motivation: * Case-management supporting to reach good family functioning * Family-based psychoeducation * Parents' and children's groups with integrated peer-support * Parenting support and training * Mapping and nurturing of resources in the social network and social counseling * Early assessment of children's possible mental health problems * All elements will be adapted to the age of the children (details available upon request) |
| Treatment as usual (TAU) | Active comparator | Other: VIA Family 2.0TAU varies to some extent in the two regions, but common is that it consists of 2-3 family consultations (family sessions) with the presence of parents and all children above the age of six years. These consultations will be managed by the Center for Relatives in the North Denmark Region and by the clinical 'child key persons' , who are staff with a special training in children and family impact in all departments of mental health services in the Capital Region. The child is also referred to participate in a psychoeducational group for same aged children. Children can participate in a group with peers, who have a parent with a mental illness as well. These groups are run by two therapists with many years of experience working with groups like this for different age groups. Participation in groups like this is voluntary, and not all children continue in a group after the family consultations. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIA Family 2.0Multidisciplinary team based preventive intervention. For details, please see arm/group description. | Other | Treatment as usual (TAU), VIA Family 2.0 |
Primary outcome
Change in Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline, end of intervention (24 months) and 36 months follow up.
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
Time frame: Baseline, after 6 months, after 12 months, after 18 months and after 24 months.
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)
Time frame: Baseline, end of intervention (24 months), and 36 months follow up
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)
Time frame: Baseline, end of intervention (24 months) and 36 months follow up.
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.
5 secondary outcomes
Change in Home Observation for Measurement of the Environment (HOME)
Time frame: Baseline, end of intervention (24 months) and 36 months follow up.
Change in Parenting and Family Adjustment Scales (PAFAS)
Time frame: Baseline, end of intervention (24 months), and 36 months follow up
Change in Children's Global Assessment Scale (CGAS)
Time frame: Baseline, end of intervention (24 months) and 36 months follow up
Change in Perceived Stress Scale (PSS)
Time frame: Baseline, end of intervention (24 months) and 36 months follow up.
Client Satisfaction Scale (CSQ)
Time frame: End of intervention (24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Derived from this study: PubMed 42192567Heuckendorff S, Ranning A, Ingversen S, Vinding R, Bars EM, Forman J, Muller AD, Hjorthoj C, Moszkowicz M, Kristensen JS, Lauritsen MB, Sandberg J, Eplov LF, Nordentoft M, Thorup AAE. The VIA Family 2.0 study: a randomized clinical trial evaluating a family-based intervention for children born to parents with mental illnesses-study protocol. Trials. 2026 May 27;27(1):509. doi: 10.1186/s13063-026-09792-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIA Family 2.0 in people with Child and Parents, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne A.E. Thorup, Professor (+4526210826, Anne.Amalie.Elgaard.Thorup@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Strengths and Difficulties Questionnaire (SDQ) (time frame: Baseline, end of intervention (24 months) and 36 months follow up.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06312410, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.