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

NCT06468046 | Recruiting

• 1 other identifier: HS-2023-0135
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Interventional

Keywords

parenting intervention; mental health; migrant mothers

Outcome Measures

Primary Outcomes (3)

• Depression symptoms (Patient Health Questionnaire [PHQ]-9)

  Survey of Depression symptoms (PHQ-9), scores range from 1-27 with higher scores indicating more severe depression

  Baseline, post-intervention (Approximately 6-weeks after baseline), and post-intervention follow-ups (2-months, 4-months, and 6-months post-intervention)

• Anxiety symptoms (General Anxiety Disorder [GAD]-7)

  Survey of Anxiety symptoms (GAD-7), scores range from 0-21, with higher scores indicating higher levels of anxiety.

  baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)

• Parental Stress Scale

  Survey of Parental Stress, Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.

  baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)

Study Arms (2)

Mama Empoderada (Mom Power)

EXPERIMENTAL

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.

Behavioral: Mama Empoderada [Mom Power]

Standard of care

NO INTERVENTION

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).

Interventions

Mama Empoderada [Mom Power] 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.

Mama Empoderada (Mom Power)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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'

You may not qualify if:

• 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).

Sponsors & Collaborators

• San Diego State University: lead
• El Colegio de la Frontera Norte: collaborator

Study Sites (1)

Al Otro Lado

Tijuana, Estado de Baja California, 22000, Mexico

RECRUITING

Related Publications (1)

• Goldenberg SM, Ramage K, Martinez-Torteya C, Pitpitan E, Rosenblum K, Hernandez C, Alvarez M, Rangel G, Bojorquez-Chapela I. Mama Empoderada: study protocol for a pilot trial of a novel parenting and mental health prevention intervention for migrant mothers with young children at the Mexico-US border. BMJ Open. 2025 Jan 28;15(1):e094917. doi: 10.1136/bmjopen-2024-094917.

  PMID: 39880445 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Shira Goldenberg, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shira Goldenberg, PhD

CONTACT

858-210-2021; sgoldenberg@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 21, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)