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NCT Number: NCT06468046

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

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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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al Otro Lado

Tijuana, Estado de Baja California, 22000, Mexico

Location status: Recruiting

Location contact

Monica Alvarez, Masters

CONTACT

+52 664 328 7551

About this study

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:

  • Conduct a pilot study of the adapted intervention to determine acceptability and estimate effect sizes on symptoms of depression, anxiety, and parenting stress; and
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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)

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

  2. 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)

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

  3. 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)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Shira Goldenberg, PhD

CONTACT

[email protected]

858-210-2021

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • El Colegio de la Frontera Norte

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2024
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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