Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315114
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-05
Brief Title:
A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders
Sponsor:
Mental Health Services in the Capital Region Denmark
Organization:
Mental Health Services in the Capital Region Denmark
Study Overview
Official Title:
A Transdiagnostic Mentalization-based Intervention LIGHTHOUSE Parenting Program Versus Care as Usual for Parents With Mental Disorders in Adult Mental Health Service a Randomised Clinical Trial
Status:
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:
LIGHTHOUSE
Brief Summary:
The aim of this randomised clinical trial is to evaluate the short and longterm effects of a transdiagnostic mentalization-based intervention Lighthouse MBT Parenting Program compared to care as usal CAU for parents with a mental disorder in adult mental health service
Detailed Description:
According to the World Health Organization WHO 970 million people worldwide suffer from mental disorders many of whom are parents Cross-sectional studies indicate that between 15-55 of the patients attending adult mental health service AMHS are parents In Denmark about 430000 children have at least one parent with a mental disorder
Parental mental health problems have a detrimental impact on parenting leading to long-term negative consequences for their children Robust evidence shows that children of parents with mental disorders have an elevated risk of various adverse outcomes and events such as developing a mental disorder themselves and exposure to child maltreatment compared to children of healthy unaffected parents suggesting an intergenerational transmission of adversity from parent to child Mental disorders in parents thus leaves deep traces throughout their childrens lives and entails major socio-economic consequences Given the high prevalence and substantial burden of parental mental disorders there is an urgent need for evidence-based interventions targeting the specific needs of this population to prevent the adverse impact on their children Despite this the existing services in AMHS for parents with mental disorders are insufficient and not evidence based The present trial seeks to fill in this gap
This is an investigator-initiated single-center two-arm parallel group randomized clinical trial testing for superiority of a transdiagnostic mentalization-based intervention Lighthouse MBT Parenting Program versus care as usual in 170 parents with various mental disorders The experimental intervention and active control group intervention are delivered as an add-on to the participants outpatient treatment
Participants will be recruited from the outpatient clinics at Psychotherapy Centre Stolpegaard PCS Capital Region of Denmark Participants will be included if they comply with the eligibility criteria Participants will be assessed at baseline and at 6 12 and 24 months follow-up after randomization
Parental mental health problems have a detrimental impact on parenting leading to long-term negative consequences for their children Robust evidence shows that children of parents with mental disorders have an elevated risk of various adverse outcomes and events such as developing a mental disorder themselves and exposure to child maltreatment compared to children of healthy unaffected parents suggesting an intergenerational transmission of adversity from parent to child Mental disorders in parents thus leaves deep traces throughout their childrens lives and entails major socio-economic consequences Given the high prevalence and substantial burden of parental mental disorders there is an urgent need for evidence-based interventions targeting the specific needs of this population to prevent the adverse impact on their children Despite this the existing services in AMHS for parents with mental disorders are insufficient and not evidence based The present trial seeks to fill in this gap
This is an investigator-initiated single-center two-arm parallel group randomized clinical trial testing for superiority of a transdiagnostic mentalization-based intervention Lighthouse MBT Parenting Program versus care as usual in 170 parents with various mental disorders The experimental intervention and active control group intervention are delivered as an add-on to the participants outpatient treatment
Participants will be recruited from the outpatient clinics at Psychotherapy Centre Stolpegaard PCS Capital Region of Denmark Participants will be included if they comply with the eligibility criteria Participants will be assessed at baseline and at 6 12 and 24 months follow-up after randomization
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H-23064491 | OTHER | Regional Committee of Health Research Ethics VEK | None |