Developing and Testing Motherly App: a Smartphone Application to Promote Mothers' Mental Health

Maternal Depression Clinical Trial

Official title:

Developing and Testing Motherly: An Automated Gamified Smartphone Application to Promote Mothers' Mental Health

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03955718
• Other study ID #: SB-POC-1810-20573
• Status: Withdrawn
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Maternal Depression

Intervention

Behavioral:
• Motherly App
The Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development.
• Educational App (Active Control)
An app with educational content about gestation, maternal health and mental health, child development, etc.

Locations

Country	Name	City	State
Brazil	Daniel Fatori	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação Maria Cecilia Souto Vidigal, Grand Challenges Canada

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal depression	Maternal depression measured by the Patient Health Questionnaire (PHQ-9), less than 10 points in the scale	At 3 months of the child's age
Secondary	Quality of sleep: Bergen Insomnia Scale	Quality of sleep measured by the Bergen Insomnia Scale	Monthly up to 3 months of the child's age
Secondary	Quality of maternal diet: questionnaire	Quality of maternal diet measured by a 14-item questionnaire developed for the present study.	Monthly up to 3 months of the child's age
Secondary	Physical activity	Physical activity measured by accelerator data from the smartphone.	Monthly up to 3 months of the child's age
Secondary	Psychological well-being	Psychological well-being measured by the Ryff's Psychological well-being scales	Monthly up to 3 months of the child's age
Secondary	General well-being	WHO-5 Well-Being Index	3 months of the child's age
Secondary	Maternal anxiety	Maternal anxiety measured by the General Anxiety Disorder 7 scale	3 months of the child's age
Secondary	Maternal self-efficacy: General Self-efficacy Scale	Maternal self-efficacy measured by the General Self-efficacy Scale	3 months of the child's age
Secondary	Quality of stimulation and support available to the child in the home environment: Home Observation for Measurement of the Environment	Quality of stimulation and support available to the child in the home environment measured by the Home Observation for Measurement of the Environment	3 months of the child's age
Secondary	Maternal parenting stress	Maternal parenting stress measured by the Parenting Stress Index (PSI)	3 months of the child's age
Secondary	Child development	Child developmental milestones measured by in-app questions	After child birth up to 3 months of the child's age
Secondary	Child developmental milestones	Child developmental milestones measured by the Survey of Well-being of Young Children (SWYC)	3 months of the child's age