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

Study 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.

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

Conditions
-----------------
Maternal Depression

Intervention / Treatment
-----------------
* Behavioral: Motherly App
* Behavioral: Educational App (Active Control)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motherly App<br>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<br>* The Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development.<br>|
| Active Comparator: Educational App (Active Control)<br>An app with educational content about gestation, maternal health and mental health, child development, etc. | Behavioral: Educational App (Active Control)<br>* An app with educational content about gestation, maternal health and mental health, child development, etc.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Physical activity | Physical activity measured by accelerator data from the smartphone. | 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 | Monthly up to 3 months of the child's age | 
| General well-being | WHO-5 Well-Being Index | 3 months of the child's age | 
| Maternal anxiety | Maternal anxiety measured by the General Anxiety Disorder 7 scale | 3 months of the child's age | 
| Maternal self-efficacy: General Self-efficacy Scale | Maternal self-efficacy measured by the 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 | 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 | 
| Maternal parenting stress | Maternal parenting stress measured by the Parenting Stress Index (PSI) | 3 months of the child's age | 
| Child development | Child developmental milestones measured by in-app questions | 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) | 3 months of the child's age |