Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468046
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-10
Brief Title:
Mama Empoderada Adapting a Novel Mental Health Prevention Intervention for Migrant Mothers With Young Children
Sponsor:
San Diego State University
Organization:
San Diego State University
Study Overview
Official Title:
Mama Empoderada Adapting a Novel Mental Health Prevention Intervention for Migrant Mothers With Young Children in a Humanitarian Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This pilot randomized controlled trial will test a theory-based trauma-informed and culturally-tailored intervention Mama Empoderada Mom Power to promote mental health and positive parenting among migrant mothers with young children
Detailed Description:
The goal of this randomized controlled trial is to adapt and pilot-test a novel mental health prevention intervention for migrant mothers with young children in a humanitarian setting
This pilot trial will adapt Mama Empoderada Mom Power - a theory-based trauma-informed culturally-tailored group intervention to promote mental health and positive parenting among mothers with young children 0-5 years for the first time Aims are to
1 Conduct a pilot study of the adapted intervention to determine acceptability and estimate effect sizes on symptoms of depression anxiety and parenting stress and
2 Explore which theory-based mechanisms of action predict changes in symptoms of depression anxiety and parenting stress and identify factors associated with differential intervention response
The intervention group will receive trauma-informed group and individual sessions on parenting linkage to resources eg food shelter social support and resilience The control group will receive standard of care programming
Both groups will complete baseline and exit surveys as well as follow-up surveys at 2- 4- and 6- months post-intervention
This pilot trial will adapt Mama Empoderada Mom Power - a theory-based trauma-informed culturally-tailored group intervention to promote mental health and positive parenting among mothers with young children 0-5 years for the first time Aims are to
1 Conduct a pilot study of the adapted intervention to determine acceptability and estimate effect sizes on symptoms of depression anxiety and parenting stress and
2 Explore which theory-based mechanisms of action predict changes in symptoms of depression anxiety and parenting stress and identify factors associated with differential intervention response
The intervention group will receive trauma-informed group and individual sessions on parenting linkage to resources eg food shelter social support and resilience The control group will receive standard of care programming
Both groups will complete baseline and exit surveys as well as follow-up surveys at 2- 4- and 6- months post-intervention
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