Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05615324
Status:
RECRUITING
Last Update Posted:
2022-11-17
First Post:
2022-10-26
Brief Title:
SAFIR Family Talk - Investigating the Effect of The Family Talk Intervention
Sponsor:
Mental Health Services in the Capital Region Denmark
Organization:
Mental Health Services in the Capital Region Denmark
Study Overview
Official Title:
The Randomized Clinical Trial SAFIR FAMILY TALK a Short Family-based Early Intervention vs Service as Usual for Children of Parents With Mental Illness in the Capital Region of Denmark
Status:
RECRUITING
Status Verified Date:
2022-11
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:
The goal of this clinical trial is to test the effect of the Family Talk Preventive Intervention compared to service as usual for families where a parent has mental illness Participants are the parent with a mental illness receiving treatment from a secondary mental health service within the last two years from inclusion their youngest child aged 7-17 years and the other parent of this child The main questions it aims to answer are
Is Family Talk superior to service as usual regarding improving
The childs level of functioning
The parents sense of competence
Family functioning Participants will undergo interviews and fill out questionnaires Half will be randomized to Family Talk and receive a manualized family-based intervention of approximately 8 conversations with a trained Family Talk interventionist The other half will be randomized to service as usual which is normally two conversations with a professional in the mental health sector The researchers will compare the two groups on childs level of functioning parental sense of competence and family functioning
Is Family Talk superior to service as usual regarding improving
The childs level of functioning
The parents sense of competence
Family functioning Participants will undergo interviews and fill out questionnaires Half will be randomized to Family Talk and receive a manualized family-based intervention of approximately 8 conversations with a trained Family Talk interventionist The other half will be randomized to service as usual which is normally two conversations with a professional in the mental health sector The researchers will compare the two groups on childs level of functioning parental sense of competence and family functioning
Detailed Description:
Children of parents with mental illness are at increased risk for mental illness themselves and therefore interventions aimed at mitigating this risk are important The Family Talk Preventive Intervention was developed by William Beardslee in the 1980s for families with parental depression but has been widely used to treat families with other mental health conditions as well Nevertheless only few high-quality clinical trials exist and the results are inconclusive
The objective of this clinical trial is to test the effect of Family Talk Preventive Intervention compared to service as usual for families where a parent has mental illness and receiving treatment from a secondary mental health service within the last two years from inclusion Participants are the parent with a mental illness their youngest child aged 7-17 years and the other parent of this child The hypothesis is that Family Talk will be superior to service as usual in improving the childs level of functioning the parents sense of competence and family functioning at 4 moths follow-up
Participants will undergo interviews and fill out questionnaires at baseline four- and twelve months follow-up assessments Half of the families will be randomized to Family Talk and receive a manualized family-based intervention of approximately 8 conversations with a trained Family Talk interventionist The other half will be randomized to service as usual which is normally two conversations with a professional in the mental health sector The researchers will compare the two groups on childs level of functioning parental sense of competence and family functioning and other measures including childs quality of life communication in the family and parental personal recovery
The objective of this clinical trial is to test the effect of Family Talk Preventive Intervention compared to service as usual for families where a parent has mental illness and receiving treatment from a secondary mental health service within the last two years from inclusion Participants are the parent with a mental illness their youngest child aged 7-17 years and the other parent of this child The hypothesis is that Family Talk will be superior to service as usual in improving the childs level of functioning the parents sense of competence and family functioning at 4 moths follow-up
Participants will undergo interviews and fill out questionnaires at baseline four- and twelve months follow-up assessments Half of the families will be randomized to Family Talk and receive a manualized family-based intervention of approximately 8 conversations with a trained Family Talk interventionist The other half will be randomized to service as usual which is normally two conversations with a professional in the mental health sector The researchers will compare the two groups on childs level of functioning parental sense of competence and family functioning and other measures including childs quality of life communication in the family and parental personal recovery
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