Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312410
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-28
Brief Title:
The VIA Family 20 - a Family Based Intervention for Families With Parental Mental Illness
Sponsor:
Mental Health Services in the Capital Region Denmark
Organization:
Mental Health Services in the Capital Region Denmark
Study Overview
Official Title:
The VIA Family 20 Study a Randomized Clinical Trial Evaluating Family-based Interventions for Children Born to Parents With Mental Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
VIA Family 20 - a Family Based Intervention for families with parental mental illness
Background Children born to parents with mental illness have consistently been shown to have increased risks for a range of negative life outcomes including increased frequencies of mental disorders somatic disorders poorer cognitive functioning social emotional and behavioral problems and lower quality of life Further these children are often overlooked by both society and mental health services although they represent a potential for prevention and early intervention
A collaboration between researchers and clinicians from two regions the Capital Region and the North Region Denmark has been established as the Research Center for Family Based Interventions The research center is an umbrella for a series of research activities all focusing on children and adolescents in families with parental mental illness
Method A large randomized controlled trial RCT for families with parental mental illness will be conducted in order to evaluate the effect of a two-year multidisciplinary holistic team intervention the VIA Family 20 team intervention against treatment as usual TAU Inclusion criteria will be biological children 0-17 of parents with any mental disorder treated in the secondary sector at any time of their life and receiving treatment in primary or secondary sector within the previous three years A total of 870 children or approx 600 families will be included from two sites Primary outcomes will be changes in child well being parental stress family functioning and quality of the home environment
Time plan The RCT will start including families from March 1st 2024 to Dec 2025 or later if needed All families will be assessed at baseline and at end of treatment ie after 24 months and after 36 months Baseline data will inform the intervention team about each familys needs problems and motivation TAU will be similar in the two regions which means three family meetings and option for children to participate in peer groups
Challenges final funding is being applied for Recruitment of families can be challenging but we have decades of experience in conducting research in the field Since both the target group their potential problems and the intervention is complex primary outcome is difficult to determine
Background Children born to parents with mental illness have consistently been shown to have increased risks for a range of negative life outcomes including increased frequencies of mental disorders somatic disorders poorer cognitive functioning social emotional and behavioral problems and lower quality of life Further these children are often overlooked by both society and mental health services although they represent a potential for prevention and early intervention
A collaboration between researchers and clinicians from two regions the Capital Region and the North Region Denmark has been established as the Research Center for Family Based Interventions The research center is an umbrella for a series of research activities all focusing on children and adolescents in families with parental mental illness
Method A large randomized controlled trial RCT for families with parental mental illness will be conducted in order to evaluate the effect of a two-year multidisciplinary holistic team intervention the VIA Family 20 team intervention against treatment as usual TAU Inclusion criteria will be biological children 0-17 of parents with any mental disorder treated in the secondary sector at any time of their life and receiving treatment in primary or secondary sector within the previous three years A total of 870 children or approx 600 families will be included from two sites Primary outcomes will be changes in child well being parental stress family functioning and quality of the home environment
Time plan The RCT will start including families from March 1st 2024 to Dec 2025 or later if needed All families will be assessed at baseline and at end of treatment ie after 24 months and after 36 months Baseline data will inform the intervention team about each familys needs problems and motivation TAU will be similar in the two regions which means three family meetings and option for children to participate in peer groups
Challenges final funding is being applied for Recruitment of families can be challenging but we have decades of experience in conducting research in the field Since both the target group their potential problems and the intervention is complex primary outcome is difficult to determine
Detailed Description:
A detailed study protocol will be published in 2024
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None