CClinicalTrials.gg
CompletedNCT06468046Updated Sep 2, 2026

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

An interventional study of Mama Empoderada [Mom Power] in Interventional, sponsored by San Diego State University. Completed at 1 site in Mexico. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by San Diego State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Interventional

Keywords

  • parenting intervention
  • mental health
  • migrant mothers
03

In context

Psychological Well-Being

974 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.

This study's enrollment of 100 is below the median of 116 across 832 interventional studies indexed under Psychological Well-Being.

Browse Psychological Well-Being studies →

Lead sponsor

San Diego State University is the lead sponsor of 145 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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).
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Mama Empoderada [Mom Power]

  • No intervention
    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).

Interventions

  • BehavioralMama 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.

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What researchers measure

Primary outcomes

  1. 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

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

  2. 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.

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

  3. Parental Stress Scale

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

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

07

Study locations

1 site
  • Al Otro Lado
    Tijuana, Estado de Baja California 22000, Mexico
08

References and documents

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. PubMed 39880445 ↗

Individual participant data

Plan to share: Yes — NIMH requires data that involve human subjects to be shared using the NDA (see NOT-MH-23-100). Quantitative data from this pilot trial will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings described in the Aims as noted below.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06468046
Lead sponsor
San Diego State University
Collaborators
El Colegio de la Frontera Norte
Responsible party
Sponsor
First posted
Jun 21, 2024
Start date
Oct 21, 2024
Primary completion
Jun 5, 2026
Completion
Jun 5, 2026
Last update
Sep 2, 2026

Study contacts

Shira Goldenberg, PhD
principal investigator · San Diego State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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