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

Mental Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06218693
• Other study ID #: MHSCRDenmark_VIAFAMILY
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: April 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders

Intervention

Behavioral:
• VIA Family
A family-based, multi-component, individual-tailored intervention based on case-management.
• Treatment As Usual (TAU)
care as usual

Locations

Country	Name	City	State
Denmark	Research Unit at Child and Adolescent Mental Health Center, Capital Region, Denmark	Hellerup

Sponsors (3)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Child and Adolescent Mental Health Services, Research Unit, Capital Region, Denmark, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline to 4 years follow-up
Secondary	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)	Change from baseline to 4 years follow-up
Secondary	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]	Change from baseline to 4 years follow-up
Secondary	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)	Change from baseline to 4 years follow-up
Secondary	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)	Change from baseline to 4 years follow-up
Secondary	This is Me (TIM)	A child-rated questionnaire on self-esteem,higher scores indicate better self-esteem	Change from baseline to 4 years follow-up
Secondary	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	Change from baseline to 4 years follow-up
Secondary	Personal and Social Performance Scale (PSP)	A clinician rated measurement to asses global functioning in parents, higher score indicates higher functioning	Change from baseline to 4 years follow-up
Secondary	Parenting Scale (PS)	A parent-rated questionnaire on parenting (30items) Higher scores indicate dysfunctional parenting	Change from baseline to 4 years follow-up