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

Primary Purpose

Maternal Depression

Status
Withdrawn
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Motherly App
Educational App (Active Control)
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Depression

Eligibility Criteria

16 Years - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Daniel Fatori

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motherly App

Educational App (Active Control)

Arm Description

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.

An app with educational content about gestation, maternal health and mental health, child development, etc.

Outcomes

Primary Outcome Measures

Maternal depression
Maternal depression measured by the Patient Health Questionnaire (PHQ-9), less than 10 points in the scale

Secondary Outcome Measures

Quality of sleep: Bergen Insomnia Scale
Quality of sleep measured by the Bergen Insomnia Scale
Quality of maternal diet: questionnaire
Quality of maternal diet measured by a 14-item questionnaire developed for the present study.
Physical activity
Physical activity measured by accelerator data from the smartphone.
Psychological well-being
Psychological well-being measured by the Ryff's Psychological well-being scales
General well-being
WHO-5 Well-Being Index
Maternal anxiety
Maternal anxiety measured by the General Anxiety Disorder 7 scale
Maternal self-efficacy: General Self-efficacy Scale
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 Environment
Quality of stimulation and support available to the child in the home environment measured by the Home Observation for Measurement of the Environment
Maternal parenting stress
Maternal parenting stress measured by the Parenting Stress Index (PSI)
Child development
Child developmental milestones measured by in-app questions
Child developmental milestones
Child developmental milestones measured by the Survey of Well-being of Young Children (SWYC)

Full Information

First Posted
January 28, 2019
Last Updated
July 19, 2020
Sponsor
University of Sao Paulo
Collaborators
Grand Challenges Canada, Fundação Maria Cecilia Souto Vidigal
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1. Study Identification

Unique Protocol Identification Number
NCT03955718
Brief Title
Developing and Testing Motherly App: a Smartphone Application to Promote Mothers' Mental Health
Official Title
Developing and Testing Motherly: An Automated Gamified Smartphone Application to Promote Mothers' Mental Health
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The study stopped because of delays in the development of the smartphone app intervention
Study Start Date
September 25, 2019 (Anticipated)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Grand Challenges Canada, Fundação Maria Cecilia Souto Vidigal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motherly App
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational App (Active Control)
Arm Type
Active Comparator
Arm Description
An app with educational content about gestation, maternal health and mental health, child development, etc.
Intervention Type
Behavioral
Intervention Name(s)
Motherly App
Intervention Description
The Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development.
Intervention Type
Behavioral
Intervention Name(s)
Educational App (Active Control)
Intervention Description
An app with educational content about gestation, maternal health and mental health, child development, etc.
Primary Outcome Measure Information:
Title
Maternal depression
Description
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
Secondary Outcome Measure Information:
Title
Quality of sleep: Bergen Insomnia Scale
Description
Quality of sleep measured by the Bergen Insomnia Scale
Time Frame
Monthly up to 3 months of the child's age
Title
Quality of maternal diet: questionnaire
Description
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
Title
Physical activity
Description
Physical activity measured by accelerator data from the smartphone.
Time Frame
Monthly up to 3 months of the child's age
Title
Psychological well-being
Description
Psychological well-being measured by the Ryff's Psychological well-being scales
Time Frame
Monthly up to 3 months of the child's age
Title
General well-being
Description
WHO-5 Well-Being Index
Time Frame
3 months of the child's age
Title
Maternal anxiety
Description
Maternal anxiety measured by the General Anxiety Disorder 7 scale
Time Frame
3 months of the child's age
Title
Maternal self-efficacy: General Self-efficacy Scale
Description
Maternal self-efficacy measured by the General Self-efficacy Scale
Time Frame
3 months of the child's age
Title
Quality of stimulation and support available to the child in the home environment: Home Observation for Measurement of the Environment
Description
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
Title
Maternal parenting stress
Description
Maternal parenting stress measured by the Parenting Stress Index (PSI)
Time Frame
3 months of the child's age
Title
Child development
Description
Child developmental milestones measured by in-app questions
Time Frame
After child birth up to 3 months of the child's age
Title
Child developmental milestones
Description
Child developmental milestones measured by the Survey of Well-being of Young Children (SWYC)
Time Frame
3 months of the child's age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Daniel Fatori
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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