VIA Family - Family Based Early Intervention Versus Treatment as Usual
1 other identifier
interventional
96
1 country
1
Brief 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 risk.The children and their parents will be assessed at baseline and thereafter randomized and allocated to either Treatment as Usual or VIA Family.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 25, 2017
CompletedFirst Submitted
Initial submission to the registry
March 19, 2018
CompletedFirst Posted
Study publicly available on registry
April 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedMarch 16, 2023
October 1, 2020
3.3 years
March 19, 2018
March 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Change from baseline at 18 month follow-up
Secondary Outcomes (4)
Change in Childrens Behaviour Checklist (CBCL)
Change from baseline at 18 month follow-up
Change in Family Assessment Device (FAD)
Change from baseline at 18 month follow-up
Change in child's number of days absent from school
Change from baseline at 18 month follow-up
Change in Home Observation for Measurement of the Environment (HOME)
Change from baseline at 18 month follow-up
Study Arms (2)
VIA Family intervention
EXPERIMENTALVIA 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 COMPARATORTAU 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Unit at Child and Adolescent Mental Health Center, Capital Region
Copenhagen, Denmark
Related Publications (3)
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.
PMID: 40796986DERIVEDGjode 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.
PMID: 39666517DERIVEDMuller 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.
PMID: 30736834DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Thorup
Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Baseline Assessor
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2018
First Posted
April 13, 2018
Study Start
September 25, 2017
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
March 16, 2023
Record last verified: 2020-10