Clinical trial NCT06468046: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Interventional
Keywords: parenting intervention
mental health
migrant mothers
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: El Colegio de la Frontera Norte
First posted: 2024-06-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

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).

Primary outcomes:
measure: Depression symptoms (Patient Health Questionnaire [PHQ]-9)
timeFrame: Baseline, post-intervention (Approximately 6-weeks after baseline), and post-intervention follow-ups (2-months, 4-months, and 6-months post-intervention)
measure: Anxiety symptoms (General Anxiety Disorder [GAD]-7)
timeFrame: baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)
measure: Parental Stress Scale
timeFrame: baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Al Otro Lado
state: Baja California
Study officials:
affiliation: San Diego State University
name: Shira Goldenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: