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Completed

NCT Number: NCT06218693

VIA Family 4 Year Follow-up of a Family-based Preventive Intervention

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:

1. 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? 2. 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?

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Key information

Conditions

Mental Disorder Mental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VIA Family

Behavioral

A family-based, multi-component, individual-tailored intervention based on case-management.

Treatment as Usual (TAU)

Behavioral

care as usual

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Children's Global Assessment Scale (CGAS)

    Time frame: Change from baseline to 4 years follow-up

    A clinician rated measurment to asses general functioning in children (scale from 1-100. High score represent better outcome)

  2. Change in Family Assessment Device (FAD)

    Time frame: Change from baseline to 4 years follow-up

    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]

  3. Change in Home Observation for Measurement of the Environment (HOME)

    Time frame: Change from baseline to 4 years follow-up

    A clinican rated semi structured interview measuring stimulation and support in the home ( scale 0-60. High score represent better outcome)

  4. Health-Related Quality of Life Questionnaire: KIDSCREEN -10

    Time frame: Change from baseline to 4 years follow-up

    A child-rated questionnaire on Healthrelated Quality of Life., 5-point Likert Scale, score range 10-50 ( higher score better quality of life)

  5. This is Me (TIM)

    Time frame: Change from baseline to 4 years follow-up

    A child-rated questionnaire on self-esteem,higher scores indicate better self-esteem

  6. Parental Stress Scale (PSS)

    Time frame: Change from baseline to 4 years follow-up

    A parent-rated questionnaire on the quality of experienced stress related to parenting, score 1-5, higher score more perceived parental stress

  7. Personal and Social Performance Scale (PSP)

    Time frame: Change from baseline to 4 years follow-up

    A clinician rated measurement to asses global functioning in parents, higher score indicates higher functioning

  8. Parenting Scale (PS)

    Time frame: Change from baseline to 4 years follow-up

    A parent-rated questionnaire on parenting (30items) Higher scores indicate dysfunctional parenting

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Child and Adolescent Mental Health Services, Research Unit, Capital Region, Denmark
  • TrygFonden, Denmark

Registry information

Official study title

VIA Family - Family Based Early Intervention Versus Treatment as Usual- 4 Year Follow-up

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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