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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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'

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Мексика · 1 центр

• Al Otro Lado — Tijuana

Публикации

• 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

Идентификаторы

NCT: NCT06468046 · HS-2023-0135

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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