MedPath

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

Not Applicable
Withdrawn
Conditions
Maternal Depression
Interventions
Behavioral: Motherly App
Behavioral: Educational App (Active Control)
Registration Number
NCT03955718
Lead Sponsor
University of Sao Paulo
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Female
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Motherly AppMotherly AppA 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.
Educational App (Active Control)Educational App (Active Control)An app with educational content about gestation, maternal health and mental health, child development, etc.
Primary Outcome Measures
NameTimeMethod
Maternal depressionAt 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 Outcome Measures
NameTimeMethod
Maternal self-efficacy: General Self-efficacy Scale3 months of the child's age

Maternal self-efficacy measured by the General Self-efficacy Scale

Quality of stimulation and support available to the child in the home environment: Home Observation for Measurement of the Environment3 months of the child's age

Quality of stimulation and support available to the child in the home environment measured by the Home Observation for Measurement of the Environment

Child developmental milestones3 months of the child's age

Child developmental milestones measured by the Survey of Well-being of Young Children (SWYC)

Psychological well-beingMonthly up to 3 months of the child's age

Psychological well-being measured by the Ryff's Psychological well-being scales

Quality of sleep: Bergen Insomnia ScaleMonthly up to 3 months of the child's age

Quality of sleep measured by the Bergen Insomnia Scale

Physical activityMonthly up to 3 months of the child's age

Physical activity measured by accelerator data from the smartphone.

General well-being3 months of the child's age

WHO-5 Well-Being Index

Maternal anxiety3 months of the child's age

Maternal anxiety measured by the General Anxiety Disorder 7 scale

Child developmentAfter child birth up to 3 months of the child's age

Child developmental milestones measured by in-app questions

Quality of maternal diet: questionnaireMonthly up to 3 months of the child's age

Quality of maternal diet measured by a 14-item questionnaire developed for the present study.

Maternal parenting stress3 months of the child's age

Maternal parenting stress measured by the Parenting Stress Index (PSI)

Trial Locations

Locations (1)

Daniel Fatori

🇧🇷

São Paulo, Brazil

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