Mama Empoderada: Adapting a Novel Mental Health Prevention Intervention for Migrant Mothers With Young Children

Not Applicable

Recruiting

• Conditions: Interventional
• Interventions: Behavioral: Mama Empoderada [Mom Power]

• Registration Number: NCT06468046
• Lead Sponsor: San Diego State University

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 (e.g., 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 Timeline

• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-21
• Study Start: 2024-10-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Self-identify as a mother to at least one accompanying child <6 years of age
• At least 18 years old
• Migrated to Tijuana from a Latin American country other than Mexico, or born in Mexico and internally displaced
• Able to provide informed consent
• Screen below cut-offs for major depression and anxiety disorder
• Able to speak Spanish
• Available to participate in full duration of 'Mama Empoderada'

Exclusion Criteria

• Not a mother or only accompanied by older children (> age 6)
• Less than 18 years of age
• Migrated to Tijuana from region outside of Latin America or non-migrant
• Unable to provide informed consent
• Screen above cut-offs for major depression and anxiety disorders
• Unable to speak Spanish
• Unable to participate in full intervention (either control or intervention group).

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mama Empoderada (Mom Power)	Mama Empoderada [Mom Power]	Behavioral: The intervention group will receive the Mama Empoderada intervention, which is a theory- based, trauma-informed, culturally tailored group intervention to promote mental health and positive parenting outcomes among trauma-exposed mothers with young children (0-5 years). Intervention participants will receive 10 group and 3 individual sessions addressing parenting, active linkage to resources (e.g., food, shelter, migration), social support, and resilience.

Primary Outcome Measures

Name	Time	Method
Anxiety symptoms (General Anxiety Disorder [GAD]-7)	baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)	Survey of Anxiety symptoms (GAD-7), scores range from 0-21, with higher scores indicating higher levels of anxiety.
Parental Stress Scale	baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)	Survey of Parental Stress, Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.
Depression symptoms (Patient Health Questionnaire [PHQ]-9)	Baseline, post-intervention (Approximately 6-weeks after baseline), and post-intervention follow-ups (2-months, 4-months, and 6-months post-intervention)	Survey of Depression symptoms (PHQ-9), scores range from 1-27 with higher scores indicating more severe depression

Trial Locations

Locations (1)

Al Otro Lado; 🇲🇽 Tijuana, Baja California, Mexico