Mental DisorderNCT06218693
VIA Family 4 Year Follow-up of a Family-based Preventive Intervention
A study testing VIA Family and Treatment As Usual (TAU) in people with Mental Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
This study aims to investigate the long-term effects (2.5 years after post-intervention) of a preventive family-based intervention (VIA Family) compared with treatment as usual (TAU) for children of parents with a severe mental illness. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder
- What is being tested?
- VIA Family and Treatment As Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2022to 30 Jan 2024
- 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, Denmark
Hellerup, 2900
About this study
Official title: VIA Family - Family Based Early Intervention Versus Treatment as Usual- 4 Year Follow-up
This study aims to investigate the long-term effects (2.5 years after post-intervention) of a preventive family-based intervention (VIA Family) compared with treatment as usual (TAU) for children of parents with a severe mental illness.
Background:
Read more
Children of parents with a mental illness have an increased lifetime risk of developing a mental illness themselves. Preventive interventions for families with children with high familial risk can potentially disrupt the transgenerational transmission.
The current study is a follow-up study of a trial investigating the effect of the preventive intervention: the VIA Family trial.
The VIA Family trial investigated the superiority of a preventive family-based intervention, VIA Family, compared with treatment as usual (TAU) in improving children's, parents' and families' functioning and well-being. Eligible families had at least one parent with a lifetime severe mental illness diagnosis ( i.e. recurrent major or moderate depression, bipolar disorder, or schizophrenia spectrum disorder), at least one child between the ages of 6-12 years and lived within the Frederiksberg or Copenhagen (Denmark). The trial had a randomized, two-armed, parallel and controlled design. The participating families were randomly assigned to both groups with an allocation ratio of 1:1.
The current study is a follow-up study aiming to explore the effect of the intervention 2.5 years after post-intervention.
The main research questions for the current follow-up study are:
- Do children participating in the VIA Family intervention experience a greater decrease in symptoms of mental illness from baseline (timepoint 0) to long-term follow-up (timepoint 2) compared with children allocated to TAU?
- Do parents participating in the VIA Family intervention experience a greater decrease in perceived parental stress from baseline (timepoint 0) to long-term follow-up (timepoint 2) compared with parents allocated to TAU?
- Conditions
- Mental Disorder
- Being tested
- VIA Family, Treatment As Usual (TAU)
- Keywords
- Familial high-risk children, preventive psychiatry, offspring
- 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 FamilyBehavioural
A family-based, multi-component, individual-tailored intervention based on case-management.
Treatment As Usual (TAU)Behavioural
care 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: Behavioral: VIA Family |
| 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 within the catchment area of the study. 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: Behavioral: Treatment As Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in "Strength and Difficulties Questionnaire" (SDQ)
Parent reported 25-items questionaire of their child's behavioural and emotional difficulties, 3-point Likert scale (0,1,2), higher scores indicate more emotional or behavioral problems
Measured: Change from baseline to 4 years follow-up
Secondary outcomes (8)
Change in Children's Global Assessment 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 to 4 years 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) [Time Frame: Change from baseline at 18 month follow-up]
Measured: Change from baseline to 4 years 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 to 4 years follow-up
Health-Related Quality of Life Questionnaire: KIDSCREEN -10
A child-rated questionnaire on Healthrelated Quality of Life., 5-point Likert Scale, score range 10-50 ( higher score better quality of life)
Measured: Change from baseline to 4 years follow-up
This is Me (TIM)
A child-rated questionnaire on self-esteem,higher scores indicate better self-esteem
Measured: Change from baseline to 4 years follow-up
Parental Stress Scale (PSS)
A parent-rated questionnaire on the quality of experienced stress related to parenting, score 1-5, higher score more perceived parental stress
Measured: Change from baseline to 4 years follow-up
Personal and Social Performance Scale (PSP)
A clinician rated measurement to asses global functioning in parents, higher score indicates higher functioning
Measured: Change from baseline to 4 years follow-up
Parenting Scale (PS)
A parent-rated questionnaire on parenting (30items) Higher scores indicate dysfunctional parenting
Measured: Change from baseline to 4 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Apr 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
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 Mental DisorderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, Child and Adolescent Mental Health Services, Research Unit, Capital Region, Denmark
- Responsible party
- Sponsor
- Investigators
- Anne A E Thorup, Principal investigator, Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218693
- Sponsor's protocol ID
- MHSCRDenmark_VIAFAMILY
- Status last verified
- Apr 2024
- First submitted
- 11 Jan 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muller AD, Gjode ICT, Moszkowicz M, Frostholm EP, Kristensen JS, Forman J, Nordentoft M, Thorup AAE. Long-term effects of an intervention for families with parental severe mental illness-A 2.5-year RCT follow-up. JCPP Adv. 2026 Oct 21:e70178. doi: 10.1002/jcv2.70178. Online ahead of print.
PubMed 42910365
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. 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- 4 Year Follow-up
- ClinicalTrials.gov ID
- NCT06218693
- Acronym / sponsor ID
- MHSCRDenmark_VIAFAMILY
- Conditions
- Mental Disorder
- Keywords
- Familial high-risk children, preventive psychiatry, offspring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, Child and Adolescent Mental Health Services, Research Unit, Capital Region, Denmark
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 23 Jan 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.
This study aims to investigate the long-term effects (2.5 years after post-intervention) of a preventive family-based intervention (VIA Family) compared with treatment as usual (TAU) for children of parents with a severe mental illness.
Background:
Children of parents with a mental illness have an increased lifetime risk of developing a mental illness themselves. Preventive interventions for families with children with high familial risk can potentially disrupt the transgenerational transmission.
The current study is a follow-up study of a trial investigating the effect of the preventive intervention: the VIA Family trial.
The VIA Family trial investigated the superiority of a preventive family-based intervention, VIA Family, compared with treatment as usual (TAU) in improving children's, parents' and families' functioning and well-being. Eligible families had at least one parent with a lifetime severe mental illness diagnosis ( i.e. recurrent major or moderate depression, bipolar disorder, or schizophrenia spectrum disorder), at least one child between the ages of 6-12 years and lived within the Frederiksberg or Copenhagen (Denmark). The trial had a randomized, two-armed, parallel and controlled design. The participating families were randomly assigned to both groups with an allocation ratio of 1:1.
The current study is a follow-up study aiming to explore the effect of the intervention 2.5 years after post-intervention.
The main research questions for the current follow-up study are:
- Do children participating in the VIA Family intervention experience a greater decrease in symptoms of mental illness from baseline (timepoint 0) to long-term follow-up (timepoint 2) compared with children allocated to TAU?
- Do parents participating in the VIA Family intervention experience a greater decrease in perceived parental stress from baseline (timepoint 0) to long-term follow-up (timepoint 2) compared with parents allocated to TAU?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIA Family intervention | Experimental | Behavioral: VIA FamilyVIA 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 | Behavioral: Treatment As Usual (TAU)TAU is defined as any kind of help and support focusing on high risk children and parental mental illness within the catchment area of the study. 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 FamilyA family-based, multi-component, individual-tailored intervention based on case-management. | Behavioural | VIA Family intervention |
| Treatment As Usual (TAU)care as usual | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Change in "Strength and Difficulties Questionnaire" (SDQ)
Time frame: Change from baseline to 4 years follow-up
Parent reported 25-items questionaire of their child's behavioural and emotional difficulties, 3-point Likert scale (0,1,2), higher scores indicate more emotional or behavioral problems
8 secondary outcomes
Change in Children's Global Assessment Scale (CGAS)
Time frame: Change from baseline to 4 years follow-up
Change in Family Assessment Device (FAD)
Time frame: Change from baseline to 4 years follow-up
Change in Home Observation for Measurement of the Environment (HOME)
Time frame: Change from baseline to 4 years follow-up
Health-Related Quality of Life Questionnaire: KIDSCREEN -10
Time frame: Change from baseline to 4 years follow-up
This is Me (TIM)
Time frame: Change from baseline to 4 years follow-up
Parental Stress Scale (PSS)
Time frame: Change from baseline to 4 years follow-up
Personal and Social Performance Scale (PSP)
Time frame: Change from baseline to 4 years follow-up
Parenting Scale (PS)
Time frame: Change from baseline to 4 years 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 17 Apr 2024.
- Derived from this study: PubMed 42910365Muller AD, Gjode ICT, Moszkowicz M, Frostholm EP, Kristensen JS, Forman J, Nordentoft M, Thorup AAE. Long-term effects of an intervention for families with parental severe mental illness-A 2.5-year RCT follow-up. JCPP Adv. 2026 Oct 21:e70178. doi: 10.1002/jcv2.70178. Online ahead of print.
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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 A E 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 and Treatment As Usual (TAU) in people with Mental Disorder, 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 17 Apr 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?
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 "Strength and Difficulties Questionnaire" (SDQ) (time frame: Change from baseline to 4 years 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 NCT06218693, 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 17 Apr 2024.