Maternal DepressionNCT03955718
Developing and Testing Motherly App: a Smartphone Application to Promote Mothers' Mental Health
A study testing Motherly App in people with Maternal Depression, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Depression
- What is being tested?
- Motherly App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Sep 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- High-risk pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Maternal Depression
- Being tested
- Motherly App, Educational App (Active Control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motherly AppBehavioural
The Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development.
Educational App (Active Control)Behavioural
An app with educational content about gestation, maternal health and mental health, child development, etc.
| Study group | Role | What they receive |
|---|---|---|
| Motherly App | Experimental | 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. Receives: Behavioral: Motherly App |
| Educational App (Active Control) | Active comparator | An app with educational content about gestation, maternal health and mental health, child development, etc. Receives: Behavioral: Educational App (Active Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal depression
Maternal depression measured by the Patient Health Questionnaire (PHQ-9), less than 10 points in the scale
Measured: At 3 months of the child's age
Secondary outcomes (11)
Quality of sleep: Bergen Insomnia Scale
Quality of sleep measured by the Bergen Insomnia Scale
Measured: 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.
Measured: Monthly up to 3 months of the child's age
Physical activity
Physical activity measured by accelerator data from the smartphone.
Measured: 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
Measured: Monthly up to 3 months of the child's age
General well-being
WHO-5 Well-Being Index
Measured: 3 months of the child's age
Maternal anxiety
Maternal anxiety measured by the General Anxiety Disorder 7 scale
Measured: 3 months of the child's age
Maternal self-efficacy: General Self-efficacy Scale
Maternal self-efficacy measured by the General Self-efficacy Scale
Measured: 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
Measured: 3 months of the child's age
Maternal parenting stress
Maternal parenting stress measured by the Parenting Stress Index (PSI)
Measured: 3 months of the child's age
Child development
Child developmental milestones measured by in-app questions
Measured: 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)
Measured: 3 months of the child's age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start25 Sep 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Why it stopped: The study stopped because of delays in the development of the smartphone app intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, Fundação Maria Cecilia Souto Vidigal
- Responsible party
- Principal investigator, Guilherme Vanoni Polanczyk, MD PhD, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955718
- Sponsor's protocol ID
- SB-POC-1810-20573
- Status last verified
- Jul 2020
- First submitted
- 28 Jan 2019
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing Motherly: An Automated Gamified Smartphone Application to Promote Mothers' Mental Health
- ClinicalTrials.gov ID
- NCT03955718
- Acronym / sponsor ID
- SB-POC-1810-20573
- Conditions
- Maternal Depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study stopped because of delays in the development of the smartphone app intervention
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, Fundação Maria Cecilia Souto Vidigal
- Study start
- 25 Sep 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motherly App | Experimental | Behavioral: Motherly 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) | Active comparator | Behavioral: Educational App (Active Control)An app with educational content about gestation, maternal health and mental health, child development, etc. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- High-risk pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motherly AppThe Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development. | Behavioural | Motherly App |
| Educational App (Active Control)An app with educational content about gestation, maternal health and mental health, child development, etc. | Behavioural | Educational App (Active Control) |
Primary outcome
Maternal depression
Time frame: At 3 months of the child's age
Maternal depression measured by the Patient Health Questionnaire (PHQ-9), less than 10 points in the scale
11 secondary outcomes
Quality of sleep: Bergen Insomnia Scale
Time frame: Monthly up to 3 months of the child's age
Quality of maternal diet: questionnaire
Time frame: Monthly up to 3 months of the child's age
Physical activity
Time frame: Monthly up to 3 months of the child's age
Psychological well-being
Time frame: Monthly up to 3 months of the child's age
General well-being
Time frame: 3 months of the child's age
Maternal anxiety
Time frame: 3 months of the child's age
Maternal self-efficacy: 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
Time frame: 3 months of the child's age
Maternal parenting stress
Time frame: 3 months of the child's age
Child development
Time frame: After child birth up to 3 months of the child's age
Child developmental milestones
Time frame: 3 months of the child's age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motherly App in people with Maternal Depression, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal depression (time frame: At 3 months of the child's age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.