Mama Empoderada: Adapting a Novel Mental Health Prevention Intervention for Migrant Mothers With Young Children in a Humanitarian Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Anxiety symptoms (General Anxiety Disorder [GAD]-7)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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'
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Mama Empoderada [Mom Power] (Behavioral)
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).
结局指标
主要结局
Anxiety symptoms (General Anxiety Disorder [GAD]-7)
时间窗: 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.
Parental Stress Scale
时间窗: 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.
Depression symptoms (Patient Health Questionnaire [PHQ]-9)
时间窗: 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
次要结局
未报告次要终点