An interventional study of Motherly App and Educational App (Active Control) in Maternal Depression, sponsored by University of Sao Paulo. Withdrawn at 1 site in Brazil. Open to female participants aged 16 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-22.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Prevention
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
Browse Depression studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
A smartphone app with an automated intervention that provides strategies to prevent maternal depression and to promote child development: (1) behavioral activation, (2) sleep hygiene, (3) physical activity, (4) social support, (5) nutrition, (6) prenatal care schedule, and (7) educational content.
Behavioral: Motherly App
An app with educational content about gestation, maternal health and mental health, child development, etc.
Behavioral: Educational App (Active Control)
The Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development.
An app with educational content about gestation, maternal health and mental health, child development, etc.
Maternal depression
Maternal depression measured by the Patient Health Questionnaire (PHQ-9), less than 10 points in the scale
Time frame: At 3 months of the child's age
Quality of sleep: Bergen Insomnia Scale
Quality of sleep measured by the Bergen Insomnia Scale
Time frame: Monthly up to 3 months of the child's age
Quality of maternal diet: questionnaire
Quality of maternal diet measured by a 14-item questionnaire developed for the present study.
Time frame: Monthly up to 3 months of the child's age
Physical activity
Physical activity measured by accelerator data from the smartphone.
Time frame: Monthly up to 3 months of the child's age
Psychological well-being
Psychological well-being measured by the Ryff's Psychological well-being scales
Time frame: Monthly up to 3 months of the child's age
General well-being
WHO-5 Well-Being Index
Time frame: 3 months of the child's age
Maternal anxiety
Maternal anxiety measured by the General Anxiety Disorder 7 scale
Time frame: 3 months of the child's age
Maternal self-efficacy: General Self-efficacy Scale
Maternal self-efficacy measured by the General Self-efficacy Scale
Time frame: 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
Quality of stimulation and support available to the child in the home environment measured by the Home Observation for Measurement of the Environment
Time frame: 3 months of the child's age
Maternal parenting stress
Maternal parenting stress measured by the Parenting Stress Index (PSI)
Time frame: 3 months of the child's age
Child development
Child developmental milestones measured by in-app questions
Time frame: After child birth up to 3 months of the child's age
Child developmental milestones
Child developmental milestones measured by the Survey of Well-being of Young Children (SWYC)
Time frame: 3 months of the child's age
Plan to share: No
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This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo