Developing and Testing Motherly: An Automated Gamified Smartphone Application to Promote Mothers' Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Maternal depression
研究概览
简要总结
The investigators plan to develop and test Motherly, a smartphone app to promote maternal mental health and child development. The Motherly app is visually appealing aimed at engaging the user with a minimalistic layout. The app will offer a gamified experience ideal for engaging youth in behaviors that can promote mental health, such as stimulating pleasure, productivity, and physical activities, connecting with peers, and eating healthy food. Pregnant women aged 16-34 living in Brazil will participate in the clinical trial to test the efficacy of the 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Literate women in the first or second trimester of pregnancy
- •Living in Brazil
- •Owning a functional smartphone for personal use with Android or iOS operational system
排除标准
- •High-risk pregnancy
结局指标
主要结局
Maternal depression
时间窗: At 3 months of the child's age
Maternal depression measured by the Patient Health Questionnaire (PHQ-9), less than 10 points in the scale
次要结局
- Maternal self-efficacy: General Self-efficacy Scale(3 months of the child's age)
- Quality of stimulation and support available to the child in the home environment: Home Observation for Measurement of the Environment(3 months of the child's age)
- Child developmental milestones(3 months of the child's age)
- Psychological well-being(Monthly up to 3 months of the child's age)
- Quality of sleep: Bergen Insomnia Scale(Monthly up to 3 months of the child's age)
- Physical activity(Monthly up to 3 months of the child's age)
- General well-being(3 months of the child's age)
- Maternal anxiety(3 months of the child's age)
- Quality of maternal diet: questionnaire(Monthly up to 3 months of the child's age)
- Maternal parenting stress(3 months of the child's age)
- Child development(After child birth up to 3 months of the child's age)
研究者
Guilherme Vanoni Polanczyk, MD PhD
Professor
University of Sao Paulo