DepressionMOM2NCT02938598
Motivating Our Mothers 2
A study testing Maternal Depression Education and Care-Seeking Motivation in people with Depression and Maternal Care Patterns, run by University of California, Davis at 1 site in United States.
Trial summary
Mothers with symptoms suggesting clinical depression can be identified and potentially motivated to seek further care during pediatric visits for their young children. The best ways for pediatric providers to encourage mothers to seek further evaluation and treatment for their depressive symptoms are not known. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Depression, Maternal Care Patterns
- What is being tested?
- Maternal Depression Education and Care-Seeking Motivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 23 May 2019
- 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primarily responsible for the day-to-day care of and obtaining pediatric care for the child with which they are presenting to the pediatric clinic;
- speak and read English or Spanish well enough to participate effectively in guided discussion;
- positive maternal depression screen;
- child aged 0-12 years;
- presenting only for well-child care;
- not currently under active and regular care for depression;
- not previously enrolled in the study.
Who cannot join
- unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis, Department of Pediatrics
Sacramento, California, 95817
About this study
Official title: Optimizing a Pediatric Intervention to Increase Maternal Depression Care-Seeking
Mothers with symptoms suggesting clinical depression can be identified and potentially motivated to seek further care during pediatric visits for their young children. The best ways for pediatric providers to encourage mothers to seek further evaluation and treatment for their depressive symptoms are not known. The investigators plan to provisionally optimize a pediatric office-based intervention that the investigators developed to motivate mothers who may be depressed to seek further care and, thereby to improve the well-being of women from diverse backgrounds and their children.
Read the detailed description
Depression in mothers parenting young children is common and undertreated. Depression is debilitating for mothers, negatively affects their parenting, and is associated with mental, behavioral, and physical health problems in their children. Identifying and treating mothers with depression improves both the mothers' well-being and their children's mental and overall health. Pediatric visits offer a potential significant opportunity to intervene. Mothers may see their child's pediatric provider more often than their own, and these providers could motivate mothers to seek effective, underutilized, formal depression care, by communicating how recovery from depression is linked to child well-being.
Therefore, in recent pilot work, the investigators developed a pediatric setting-based intervention that includes a validated maternal depression screen, and subsequent depression education and care-seeking motivational messages that emphasize the benefits of maternal depression care for children. Initial testing demonstrated that depression screen-positive mothers receiving the intervention had greater intention and attempts to seek depression care compared to mothers receiving usual care. The investigators then professionally translated the intervention into Spanish as a first step in increasing the generalizability of the intervention through refinement in future studies. As is often the case with interventions tested as a package, the investigators lack empirical evidence on which components of the pilot intervention deliver the greatest effects. Therefore, the investigators propose to adopt a rapid-cycle intervention improvement approach.
In this trial, the investigators will assess the effects intervention refinements on depression screen-positive mothers' depression care-seeking, using a factorial randomized design. The resulting intervention will be provisionally optimized by including only those refined components found to be most experimentally efficacious. This provisionally optimized intervention will have a higher probability of demonstrating reproducible effectiveness, potentially speeding the way to implementation. The ultimate optimized intervention will improve maternal depression care by being an essential link in future integrated systems between pediatric-based maternal depression screening and effective community-based programs for maternal mental health care.
The investigators modified the initial anticipated sample size reported from 312 to 80. During the course of recruiting and enrollment investigators found the need to reorient the trial to one of feasibility and reduced the sample size accordingly. The investigators' goal is to obtain an analytic sample size that will allow for balanced numbers of participants in each cell across sites, with a minimum of 5 observations per intervention type. Given variable recruiting and retention rates, this could be a recruited sample size between 48 and 80 individuals. In addition, investigators extended the initial recruiting time frame.
- Conditions
- Depression, Maternal Care Patterns
- Being tested
- Maternal Depression Education and Care-Seeking Motivation
- Keywords
- maternal depression, pediatric-based maternal depression screening, maternal health services
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Depression Education and Care-Seeking MotivationBehavioural
Multicomponent behavioral and educational intervention. The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Engagement On - Problem Solving High - Motivation On Receives: Behavioral: Maternal Depression Education and Care-Seeking Motivation |
| B | Experimental | Engagement On - Problem Solving Low - Motivation On Receives: Behavioral: Maternal Depression Education and Care-Seeking Motivation |
| C | Experimental | Engagement On - Problem Solving High - Motivation Off Receives: Behavioral: Maternal Depression Education and Care-Seeking Motivation |
| D | Experimental | Engagement On - Problem Solving Low - Motivation Off Receives: Behavioral: Maternal Depression Education and Care-Seeking Motivation |
| E | Experimental | Engagement Off - Problem Solving High - Motivation On Receives: Behavioral: Maternal Depression Education and Care-Seeking Motivation |
| F | Experimental | Engagement Off - Problem Solving Low - Motivation On Receives: Behavioral: Maternal Depression Education and Care-Seeking Motivation |
| G | Experimental | Engagement Off - Problem Solving High - Motivation Off Receives: Behavioral: Maternal Depression Education and Care-Seeking Motivation |
| H | Experimental | Engagement Off - Problem Solving Low - Motivation Off Receives: Behavioral: Maternal Depression Education and Care-Seeking Motivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attempt to Contact a Maternal Depression Resource
Measured: 2 Weeks Post-Intervention
Secondary outcomes (1)
Intention to Contact a Maternal Depression Resource
Measured: 2 Weeks Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion23 May 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Erik O Fernandez y Garcia, MD MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938598
- Sponsor's protocol ID
- 800492
- Other IDs
- K23MH101157
- Acronym
- MOM2
- Status last verified
- Apr 2021
- First submitted
- 17 Oct 2016
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Pediatric Intervention to Increase Maternal Depression Care-Seeking
- ClinicalTrials.gov ID
- NCT02938598
- Acronym / sponsor ID
- MOM2 / 800492
- Conditions
- Depression, Maternal Care Patterns
- Keywords
- maternal depression, pediatric-based maternal depression screening, maternal health services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2016
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 19 Oct 2016 (estimated)
- 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.
Mothers with symptoms suggesting clinical depression can be identified and potentially motivated to seek further care during pediatric visits for their young children. The best ways for pediatric providers to encourage mothers to seek further evaluation and treatment for their depressive symptoms are not known. The investigators plan to provisionally optimize a pediatric office-based intervention that the investigators developed to motivate mothers who may be depressed to seek further care and, thereby to improve the well-being of women from diverse backgrounds and their children.
Detailed description
Depression in mothers parenting young children is common and undertreated. Depression is debilitating for mothers, negatively affects their parenting, and is associated with mental, behavioral, and physical health problems in their children. Identifying and treating mothers with depression improves both the mothers' well-being and their children's mental and overall health. Pediatric visits offer a potential significant opportunity to intervene. Mothers may see their child's pediatric provider more often than their own, and these providers could motivate mothers to seek effective, underutilized, formal depression care, by communicating how recovery from depression is linked to child well-being.
Therefore, in recent pilot work, the investigators developed a pediatric setting-based intervention that includes a validated maternal depression screen, and subsequent depression education and care-seeking motivational messages that emphasize the benefits of maternal depression care for children. Initial testing demonstrated that depression screen-positive mothers receiving the intervention had greater intention and attempts to seek depression care compared to mothers receiving usual care. The investigators then professionally translated the intervention into Spanish as a first step in increasing the generalizability of the intervention through refinement in future studies. As is often the case with interventions tested as a package, the investigators lack empirical evidence on which components of the pilot intervention deliver the greatest effects. Therefore, the investigators propose to adopt a rapid-cycle intervention improvement approach.
In this trial, the investigators will assess the effects intervention refinements on depression screen-positive mothers' depression care-seeking, using a factorial randomized design. The resulting intervention will be provisionally optimized by including only those refined components found to be most experimentally efficacious. This provisionally optimized intervention will have a higher probability of demonstrating reproducible effectiveness, potentially speeding the way to implementation. The ultimate optimized intervention will improve maternal depression care by being an essential link in future integrated systems between pediatric-based maternal depression screening and effective community-based programs for maternal mental health care.
The investigators modified the initial anticipated sample size reported from 312 to 80. During the course of recruiting and enrollment investigators found the need to reorient the trial to one of feasibility and reduced the sample size accordingly. The investigators' goal is to obtain an analytic sample size that will allow for balanced numbers of participants in each cell across sites, with a minimum of 5 observations per intervention type. Given variable recruiting and retention rates, this could be a recruited sample size between 48 and 80 individuals. In addition, investigators extended the initial recruiting time frame.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Maternal Depression Education and Care-Seeking MotivationEngagement On - Problem Solving High - Motivation On |
| B | Experimental | Behavioral: Maternal Depression Education and Care-Seeking MotivationEngagement On - Problem Solving Low - Motivation On |
| C | Experimental | Behavioral: Maternal Depression Education and Care-Seeking MotivationEngagement On - Problem Solving High - Motivation Off |
| D | Experimental | Behavioral: Maternal Depression Education and Care-Seeking MotivationEngagement On - Problem Solving Low - Motivation Off |
| E | Experimental | Behavioral: Maternal Depression Education and Care-Seeking MotivationEngagement Off - Problem Solving High - Motivation On |
| F | Experimental | Behavioral: Maternal Depression Education and Care-Seeking MotivationEngagement Off - Problem Solving Low - Motivation On |
| G | Experimental | Behavioral: Maternal Depression Education and Care-Seeking MotivationEngagement Off - Problem Solving High - Motivation Off |
| H | Experimental | Behavioral: Maternal Depression Education and Care-Seeking MotivationEngagement Off - Problem Solving Low - Motivation Off |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- primarily responsible for the day-to-day care of and obtaining pediatric care for the child with which they are presenting to the pediatric clinic;
- speak and read English or Spanish well enough to participate effectively in guided discussion;
- positive maternal depression screen;
- child aged 0-12 years;
- presenting only for well-child care;
Key exclusion criteria (1 listed)
- unable to consent
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 |
|---|---|---|
| Maternal Depression Education and Care-Seeking MotivationMulticomponent behavioral and educational intervention. The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation | Behavioural | A, B, C, D, E, F, G, H |
Primary outcome
Attempt to Contact a Maternal Depression Resource
Time frame: 2 Weeks Post-Intervention
1 secondary outcome
Intention to Contact a Maternal Depression Resource
Time frame: 2 Weeks Post-Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- 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.
Erik O Fernandez y Garcia, MD MPH principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Depression Education and Care-Seeking Motivation in people with Depression and Maternal Care Patterns, run by University of California, Davis at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 13 Apr 2021. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Attempt to Contact a Maternal Depression Resource (time frame: 2 Weeks Post-Intervention). 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 13 Apr 2021.