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

Interventional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06468046
• Other study ID #: HS-2023-0135
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: August 2026

Study information

• Verified date: May 2024
• Source: San Diego State University
• Contact: Shira Goldenberg, PhD
• Phone: 858-210-2021
• Email: sgoldenberg[@]sdsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot randomized controlled trial (RCT) will test a theory-based intervention [Mamá Empoderada' (Mom Power)] to promote mental health and positive parenting among migrant mothers with young children.

Description:

The goal of this pilot study is to adapt and pilot-test a novel mental health prevention intervention for migrant mothers with young children (MMC) in a humanitarian setting.

This pilot trial will adapt 'Mamá Empoderada' [Mom Power] - a theory-based, trauma-informed group intervention to promote mental health and positive parenting among mothers with young children (0-5 years) for the first time with MMC. 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 investigators will conduct a pilot randomized controlled trial of the adapted 'Mamá Empoderada' intervention with MMC.

The intervention group (IG) 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 written intervention materials, standard of care programming, and participate in the intervention following completion of the study by the IG (i.e., after 6 months).

Both groups will complete baseline and exit surveys, as well as follow-up surveys at 2-, 4- and 6- months post-intervention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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 'Mamá 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).

Related Conditions & MeSH terms

• Interventional

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	El Colegio de la Frontera Norte

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)