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

Official title

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

Overview

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

• Behavioral 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 resourc

Primary outcome measures

• Depression symptoms (Patient Health Questionnaire [PHQ]-9) [Time frame: 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) [Time frame: 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 [Time frame: baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Mexico · 1 center

• Al Otro Lado — Tijuana

Publications

• 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

Identifiers

NCT: NCT06468046 · HS-2023-0135

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗