Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519051
Status:
COMPLETED
Last Update Posted:
2007-08-21
First Post:
2007-08-17
Brief Title:
A Randomized Clinical Trial for Depressed Mothers at Primary Care Level
Sponsor:
Fondo Nacional de Desarrollo Científico y Tecnológico Chile
Organization:
Fondo Nacional de Desarrollo Científico y Tecnológico Chile
Study Overview
Official Title:
Efectividad de la Farmacoterapia Monitorizada en Pacientes Deprimidas de la atención Primaria de Salud y su repercusión Sobre la Salud Mental de Sus Hijos
Status:
COMPLETED
Status Verified Date:
2007-08
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:
DMH
Brief Summary:
A randomized clinical trial was carried out at primary care level in Santiago Chile to compare a pharmacological intervention for depressed mothers controlled by phone from a central level TM and the usual treatment TH and its impact on childrens mental health
Hypothesis pharmacological intervention for depression controlled by phone from a central level will be more effective than usual care in depressed mothers
Hypothesis pharmacological intervention for depression controlled by phone from a central level will be more effective than usual care in depressed mothers
Detailed Description:
Aimto compare a pharmacological intervention for depressed mothers controlled by phone from a central level TM and the usual treatment TH and its impact on childrens mental health
Material and methods A RCT wasw carried out at primary care clinics in SantiagoSamplethree hundred and forty five depressed women One children of each mother was randomly selected Women are randomly assigned to receive the usual therapy or a pharmacological intervention with periodical telephone contacts with medical collaboration personnel to reinforce compliance with treatment and educate about the disease for 6 months Women were blindly evaluated at 3 6 and 12 months with the Hamilton depression rating score HDRS and the SF-36 to assess depressive symptoms and quality of life respectively the Dyadic Adjustment Scale to assess marital adjustment
Child psychopathology was assessed with the Child Behavior Checklist CBCL the Brief Psychiatric Rating Scale for Children BPRS-C Screen for Child Anxiety Related Emotional DisordersSCAREDand the Childrens Depression Inventory
Material and methods A RCT wasw carried out at primary care clinics in SantiagoSamplethree hundred and forty five depressed women One children of each mother was randomly selected Women are randomly assigned to receive the usual therapy or a pharmacological intervention with periodical telephone contacts with medical collaboration personnel to reinforce compliance with treatment and educate about the disease for 6 months Women were blindly evaluated at 3 6 and 12 months with the Hamilton depression rating score HDRS and the SF-36 to assess depressive symptoms and quality of life respectively the Dyadic Adjustment Scale to assess marital adjustment
Child psychopathology was assessed with the Child Behavior Checklist CBCL the Brief Psychiatric Rating Scale for Children BPRS-C Screen for Child Anxiety Related Emotional DisordersSCAREDand the Childrens Depression Inventory
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None