CompletedNot Applicable

VIA Family - Family Based Early Intervention Versus Treatment as Usual

Denmark96 participantsStarted 2017-09-25

Plain-language 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.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Childrens Global Assesment Scale (CGAS)

Timeframe: Change from baseline at 18 month follow-up

Trial details

NCT IDNCT03497663

SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-01

View on ClinicalTrials.gov More Early Intervention trials