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Clinical Trial Summary

This pilot randomized controlled trial (RCT) will test a theory-based intervention [Mamá Empoderada' (Mom Power)] to promote mental health and positive parenting among migrant mothers with young children.


Clinical Trial Description

The goal of this pilot study is to adapt and pilot-test a novel mental health prevention intervention for migrant mothers with young children (MMC) in a humanitarian setting. This pilot trial will adapt 'Mamá Empoderada' [Mom Power] - a theory-based, trauma-informed group intervention to promote mental health and positive parenting among mothers with young children (0-5 years) for the first time with MMC. 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 investigators will conduct a pilot randomized controlled trial of the adapted 'Mamá Empoderada' intervention with MMC. The intervention group (IG) will receive trauma-informed group and individual sessions on parenting, linkage to resources (e.g., food, shelter), social support, and resilience. The control group will receive written intervention materials, standard of care programming, and participate in the intervention following completion of the study by the IG (i.e., after 6 months). Both groups will complete baseline and exit surveys, as well as follow-up surveys at 2-, 4- and 6- months post-intervention. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06468046
Study type Interventional
Source San Diego State University
Contact Shira Goldenberg, PhD
Phone 858-210-2021
Email sgoldenberg@sdsu.edu
Status Not yet recruiting
Phase N/A
Start date July 2024
Completion date August 2026

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