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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06468046
Enrollment
100
Registered
2024-06-21
Start date
2024-10-21
Completion date
2026-06-05
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interventional

Keywords

parenting intervention, mental health, migrant mothers

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.

Interventions

BEHAVIORALMama Empoderada [Mom Power]

'Mamá Empoderada' \[Mom Power\] is a theory-based, trauma-informed group intervention to promote mental health and positive parenting among mothers with young children (0-5 years). It has been adapted for migrant mothers, and will conduct a pilot randomized controlled trial (RCT) of the intervention with migrant mothers with young children (MMC). The intervention group (IG) will receive 10 group and 3 individual sessions addressing attachment theory, hands-on parenting skills, linkage to resources (e.g., food, shelter), social support, and self-care and resilience.

Sponsors

San Diego State University
Lead SponsorOTHER
El Colegio de la Frontera Norte
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Intervention model description

The pilot randomized controlled trial (RCT) of the adapted 'Mama Empoderada' intervention with Migrant Mothers will include N=100 \[N(treatment)=50; N(control)=50\] (Aims 2-3). The intervention group (IG) will participate in trauma- informed group and individual sessions addressing parenting, active linkage to resources, social support, and resilience. The control group will receive standard of care programming, including referrals to drop-in migrant and community-based supports, childcare, and referrals to reproductive, mental health, and other services. Control group participants will have the opportunity to participate in the full intervention following completion of the intervention and all questionnaires by the intervention group (post 6-month visit). Both groups will complete baseline, exit, and follow-up (2, 4, 6-months) surveys.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
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
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 Scalebaseline, 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.

Countries

Mexico

Contacts

PRINCIPAL_INVESTIGATORShira Goldenberg, PhD

San Diego State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026