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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Maternal Depression
• Intervention / Treatment: Behavioral: Motherly App; Behavioral: Educational App (Active Control)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Daniel Fatori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Grand Challenges Canada; Fundaçao Maria Cecilia Souto Vidigal

Study record dates

Study Major Dates

• Study Start (Anticipated): September 25, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: SB-POC-1810-20573 (Grand Challenge Canada)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No