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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-21

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Interventional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Mama Empoderada [Mom Power]

Intervention Type BEHAVIORAL

'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.

Standard of care

The control group will receive standard of care programming available locally, including referrals to drop-in migrant and family 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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mama 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes