Early InterventionNCT03497663
VIA Family - Family Based Early Intervention Versus Treatment as Usual
A study testing VIA Family intervention and Treatment As Usual in people with Early Intervention and Child of Impaired Parents, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
This RCT aims to investigate the effect of an early family-based intervention (VIA Family) focusing on reducing risk and increasing resilience for children in families where at least one parent has a severe mental illness.The study is a randomized clinical trial including 100 children age 6-12 with familial high… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Intervention, Child of Impaired Parents, Child
- What is being tested?
- VIA Family intervention and Treatment As Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Sep 2017to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child must have address registered in the municipality of Frederiksberg or Copenhagen.
- At least one of the biological parents must have a diagnosis of schizophrenia spectrum disorder, bipolar affective disorder or recurrent major depression.
- The parent with a diagnosis must have had at least one in- or outpatient contact with the mental health system within the lifetime of the child.
Who cannot join
- Parents who do not speak and understand enough Danish to be able to give informed consent for their own and for the child's participation.
- If all family members are currently engaged in an intensive family intervention program addressing parental functioning and child development, they are excluded from the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit at Child and Adolescent Mental Health Center, Capital Region
Copenhagen
About this study
Official title: VIA Family - Family Based Early Intervention Versus Treatment as Usual. Study Protocol for a Randomized Clinical Trial. Can a Multidisciplinary Specialized Intervention Improve General Functioning and Decrease Symptoms of Psychopathology in Familial High Risk Children Born to Parents With Severe Mental Illness?
This RCT aims to investigate the effect of an early family-based intervention (VIA Family) focusing on reducing risk and increasing resilience for children in families where at least one parent has a severe mental illness.The study is a randomized clinical trial including 100 children age 6-12 with familial high risk.The children and their parents will be assessed at baseline and thereafter randomized and allocated to either Treatment as Usual or VIA Family.
Read the detailed description
Background: Children born to parents with severe mental illness like schizophrenia, bipolar disorder or major recurrent depression have an increased risk of developing a mental illness themselves during life. These children are also more likely to display developmental delays, cognitive disabilities, social problems and may have a higher risk than background population of experiencing adverse life events. This is due to both genetic and environmental factors, but in spite of the well documented increased risk for children with familial high risk no family-based early intervention has been developed. This study aims to investigate the effect of an early intervention model focusing on reducing risk and increasing resilience for children in families where at least one parent has a severe mental illness.
Methods: The study is a randomized clinical trial including 100 children age 6-12 with familial high risk. Families will be recruited from registers or be referred from the primary sector or from hospitals. The children and their parents will be assessed at baseline and thereafter randomized and allocated to either Treatment as Usual or VIA Family. In the VIA Family group the families will be offered regular contact with a case manager. A multidisciplinary team of specialists from Adult Mental Health Services, Child and Adolescent Mental Health Services and Social Services will be responsible for providing the basic treatment elements that are: case management, psychoeducation for the whole family, parental training (Triple P) and early intervention for mental problems of the child. The study period is 18 months for both groups and all participants will be assessed at baseline and after 18 months. Primary outcome measure will be daily functioning of the child (CGAS), and secondary measures are psychopathology in the child and days of school absence, family functioning and child's home environment.
Discussion: This study is to the investigators knowledge the first to explore the effects on children with familial high risk for severe mental illness of a multidisciplinary team intervention providing an intensive and flexible support matching the families' needs. The study will provide important knowledge about the possibilities of increasing resilience and reducing risk of a child by supporting the whole family. However, longer follow-up time may be needed.
- Conditions
- Early Intervention, Child of Impaired Parents, Child, Adolescent, Mental Disorders, Severe, Schizophrenia
- Being tested
- VIA Family intervention, Treatment As Usual
- Keywords
- Familial high risk, offspring, schizophrenia, bipolar disorder, recurrent depression, early intervention, parental training, family based intervention
- Medical subject headings
- Mental Disorders, Schizophrenia, Bipolar Disorder, Depressive Disorder, Recurrence, Psychotic Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIA Family interventionOther
Family based intervention
Treatment As UsualOther
Also called TAU
Treatment As Usual
| Study group | Role | What they receive |
|---|---|---|
| VIA Family intervention | Experimental | VIA Family is a family based intervention. A multidisciplinary team of specialists from adult mental health services, child and adolescent mental health services and social services will be responsible for providing the basic treatment elements that are: case management and regular contact with the case manager, psychoeducation for the whole family, parental training (Triple P) and early intervention for mental problems of the child. Receives: Other: VIA Family intervention |
| Treatment as Usual (TAU) | Active comparator | TAU is defined as any kind of help and support focusing on high risk children and parental mental illness. At present, the municipalities and the mental health services do not offer any kind of family focused intervention addressing parental mental illness that can be compared to the VIA Family program. Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Childrens Global Assesment Scale (CGAS)
A clinician rated measurment to asses general functioning in children (scale from 1-100. High score represent better outcome)
Measured: Change from baseline at 18 month follow-up
Secondary outcomes (4)
Change in Childrens Behaviour Checklist (CBCL)
Parent and teacher reported questionaire on child behavior ( low score represent better outcome).
Measured: Change from baseline at 18 month follow-up
Change in Family Assessment Device (FAD)
A 60 item parent report questionaire assesing family functioning ( scale 1-4. Low score represent better outcome)
Measured: Change from baseline at 18 month follow-up
Change in child's number of days absent from school
Number of days child was absent from school within the last 6 month (low number represent better outcome). Teacher rated.
Measured: Change from baseline at 18 month follow-up
Change in Home Observation for Measurement of the Environment (HOME)
A clinican rated semi structured interview measuring stimulation and support in the home ( scale 0-60. High score represent better outcome)
Measured: Change from baseline at 18 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start25 Sep 2017
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Early InterventionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The families randomly assigned to the VIA Family Group will be offered regular contact with a case manager. A multidisciplinary team of specialists from adult mental health services/psychiatry , child and adolescent mental health services and social services will be responsible for providing the basic treatment elements that are: case management, psychoeducation for the whole family, parental training (Triple P) and early intervention for mental problems of the child.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Municipality of Frederiksberg, Denmark, Ministry of the Interior and Health, Denmark, TrygFonden, Denmark
- Responsible party
- Sponsor
- Investigators
- Anne Thorup, Principal investigator, Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497663
- Sponsor's protocol ID
- VIAFAMILYFEB18
- Status last verified
- Oct 2020
- First submitted
- 19 Mar 2018
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muller AD, Gjode ICT, Christensen SH, Jorgensen SK, Fischer K, Moszkowicz M, Hemager N, Nordentoft M, Piche G, Thorup AAE. Perceived Need and Social Relatedness Contribute to Change in Selective Prevention for Mental Illness: a Mixed Methods Study. Prev Sci. 2025 Aug;26(6):908-920. doi: 10.1007/s11121-025-01831-w. Epub 2025 Aug 12.
PubMed 40796986Gjode ICT, Muller AD, Hjorthoj C, Hemager N, Ingversen S, Moszkowicz M, Christensen SH, Mikkelsen LJ, Nielsen SS, Melau M, Forman J, Nordentoft M, Thorup AAE. Effects on family functioning and the home environment of a family-based preventive intervention for children of parents with severe mental illness: A randomized controlled trial. J Consult Clin Psychol. 2025 Apr;93(4):267-280. doi: 10.1037/ccp0000924. Epub 2024 Dec 12.
PubMed 39666517Muller AD, Gjode ICT, Eigil MS, Busck H, Bonne M, Nordentoft M, Thorup AAE. VIA Family-a family-based early intervention versus treatment as usual for familial high-risk children: a study protocol for a randomized clinical trial. Trials. 2019 Feb 8;20(1):112. doi: 10.1186/s13063-019-3191-0.
PubMed 30736834
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIA Family - Family Based Early Intervention Versus Treatment as Usual. Study Protocol for a Randomized Clinical Trial. Can a Multidisciplinary Specialized Intervention Improve General Functioning and Decrease Symptoms of Psychopathology in Familial High Risk Children Born to Parents With Severe Mental Illness?
- ClinicalTrials.gov ID
- NCT03497663
- Acronym / sponsor ID
- VIAFAMILYFEB18
- Conditions
- Early Intervention, Child of Impaired Parents, Child, Adolescent, Mental Disorders, Severe, Schizophrenia
- Keywords
- Familial high risk, offspring, schizophrenia, bipolar disorder, recurrent depression, early intervention, parental training, family based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Municipality of Frederiksberg, Denmark, Ministry of the Interior and Health, Denmark, TrygFonden, Denmark
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 13 Apr 2018 (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.
This RCT aims to investigate the effect of an early family-based intervention (VIA Family) focusing on reducing risk and increasing resilience for children in families where at least one parent has a severe mental illness.The study is a randomized clinical trial including 100 children age 6-12 with familial high risk.The children and their parents will be assessed at baseline and thereafter randomized and allocated to either Treatment as Usual or VIA Family.
Detailed description
Background: Children born to parents with severe mental illness like schizophrenia, bipolar disorder or major recurrent depression have an increased risk of developing a mental illness themselves during life. These children are also more likely to display developmental delays, cognitive disabilities, social problems and may have a higher risk than background population of experiencing adverse life events. This is due to both genetic and environmental factors, but in spite of the well documented increased risk for children with familial high risk no family-based early intervention has been developed. This study aims to investigate the effect of an early intervention model focusing on reducing risk and increasing resilience for children in families where at least one parent has a severe mental illness.
Methods: The study is a randomized clinical trial including 100 children age 6-12 with familial high risk. Families will be recruited from registers or be referred from the primary sector or from hospitals. The children and their parents will be assessed at baseline and thereafter randomized and allocated to either Treatment as Usual or VIA Family. In the VIA Family group the families will be offered regular contact with a case manager. A multidisciplinary team of specialists from Adult Mental Health Services, Child and Adolescent Mental Health Services and Social Services will be responsible for providing the basic treatment elements that are: case management, psychoeducation for the whole family, parental training (Triple P) and early intervention for mental problems of the child. The study period is 18 months for both groups and all participants will be assessed at baseline and after 18 months. Primary outcome measure will be daily functioning of the child (CGAS), and secondary measures are psychopathology in the child and days of school absence, family functioning and child's home environment.
Discussion: This study is to the investigators knowledge the first to explore the effects on children with familial high risk for severe mental illness of a multidisciplinary team intervention providing an intensive and flexible support matching the families' needs. The study will provide important knowledge about the possibilities of increasing resilience and reducing risk of a child by supporting the whole family. However, longer follow-up time may be needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The families randomly assigned to the VIA Family Group will be offered regular contact with a case manager. A multidisciplinary team of specialists from adult mental health services/psychiatry , child and adolescent mental health services and social services will be responsible for providing the basic treatment elements that are: case management, psychoeducation for the whole family, parental training (Triple P) and early intervention for mental problems of the child.
| Arm | Type | Receives |
|---|---|---|
| VIA Family intervention | Experimental | Other: VIA Family interventionVIA Family is a family based intervention. A multidisciplinary team of specialists from adult mental health services, child and adolescent mental health services and social services will be responsible for providing the basic treatment elements that are: case management and regular contact with the case manager, psychoeducation for the whole family, parental training (Triple P) and early intervention for mental problems of the child. |
| Treatment as Usual (TAU) | Active comparator | Other: Treatment As UsualTAU is defined as any kind of help and support focusing on high risk children and parental mental illness. At present, the municipalities and the mental health services do not offer any kind of family focused intervention addressing parental mental illness that can be compared to the VIA Family program. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child must have address registered in the municipality of Frederiksberg or Copenhagen.
- At least one of the biological parents must have a diagnosis of schizophrenia spectrum disorder, bipolar affective disorder or recurrent major depression.
- The parent with a diagnosis must have had at least one in- or outpatient contact with the mental health system within the lifetime of the child.
Key exclusion criteria (2 listed)
- Parents who do not speak and understand enough Danish to be able to give informed consent for their own and for the child's participation.
- If all family members are currently engaged in an intensive family intervention program addressing parental functioning and child development, they are excluded from the study.
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 interventionFamily based intervention | Other | VIA Family intervention |
| Treatment As UsualAlso: TAUTreatment As Usual | Other | Treatment as Usual (TAU) |
Primary outcome
Change in Childrens Global Assesment Scale (CGAS)
Time frame: Change from baseline at 18 month follow-up
A clinician rated measurment to asses general functioning in children (scale from 1-100. High score represent better outcome)
4 secondary outcomes
Change in Childrens Behaviour Checklist (CBCL)
Time frame: Change from baseline at 18 month follow-up
Change in Family Assessment Device (FAD)
Time frame: Change from baseline at 18 month follow-up
Change in child's number of days absent from school
Time frame: Change from baseline at 18 month follow-up
Change in Home Observation for Measurement of the Environment (HOME)
Time frame: Change from baseline at 18 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 40796986Muller AD, Gjode ICT, Christensen SH, Jorgensen SK, Fischer K, Moszkowicz M, Hemager N, Nordentoft M, Piche G, Thorup AAE. Perceived Need and Social Relatedness Contribute to Change in Selective Prevention for Mental Illness: a Mixed Methods Study. Prev Sci. 2025 Aug;26(6):908-920. doi: 10.1007/s11121-025-01831-w. Epub 2025 Aug 12.
- Derived from this study: PubMed 39666517Gjode ICT, Muller AD, Hjorthoj C, Hemager N, Ingversen S, Moszkowicz M, Christensen SH, Mikkelsen LJ, Nielsen SS, Melau M, Forman J, Nordentoft M, Thorup AAE. Effects on family functioning and the home environment of a family-based preventive intervention for children of parents with severe mental illness: A randomized controlled trial. J Consult Clin Psychol. 2025 Apr;93(4):267-280. doi: 10.1037/ccp0000924. Epub 2024 Dec 12.
- Derived from this study: PubMed 30736834Muller AD, Gjode ICT, Eigil MS, Busck H, Bonne M, Nordentoft M, Thorup AAE. VIA Family-a family-based early intervention versus treatment as usual for familial high-risk children: a study protocol for a randomized clinical trial. Trials. 2019 Feb 8;20(1):112. doi: 10.1186/s13063-019-3191-0.
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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. This study is not recruiting at the moment.
Anne Thorup principal investigator
Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark
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 intervention and Treatment As Usual in people with Early Intervention and Child of Impaired 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 16 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Childrens Global Assesment Scale (CGAS) (time frame: Change from baseline at 18 month follow-up). 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 NCT03497663, which also lists 3 linked publications.
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 16 Mar 2023.