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

San Diego State University

Status: Enrolling

Conditions: Interventional

Treatments: Behavioral: Mama Empoderada [Mom Power]

Study type: Interventional

Funder types: Other

Identifiers

NCT06468046

HS-2023-0135

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Mama Empoderada (Mom Power)

Experimental group

Description:

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.

Treatment:

Behavioral: Mama Empoderada [Mom Power]

Standard of care

No Intervention group

Description:

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).