Developing and Testing Motherly: An Automated Gamified Smartphone Application to Promote Mothers' Mental Health
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Maternal Depression
- Sponsor
- University of Sao Paulo
- Locations
- 1
- Primary Endpoint
- Maternal depression
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Guilherme Vanoni Polanczyk, MD PhD
Professor
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •High-risk pregnancy
Outcomes
Primary Outcomes
Maternal depression
Time Frame: 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
Secondary Outcomes
- 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)