Motivating Our Mothers 2 (MOM2)
Optimizing a Pediatric Intervention to Increase Maternal Depression Care-Seeking
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- University of California Davis, Department of Pediatrics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- unable to consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
Engagement On - Problem Solving High - Motivation On
|
Multicomponent behavioral and educational intervention.
The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation
|
|
Experimental: B
Engagement On - Problem Solving Low - Motivation On
|
Multicomponent behavioral and educational intervention.
The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation
|
|
Experimental: C
Engagement On - Problem Solving High - Motivation Off
|
Multicomponent behavioral and educational intervention.
The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation
|
|
Experimental: D
Engagement On - Problem Solving Low - Motivation Off
|
Multicomponent behavioral and educational intervention.
The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation
|
|
Experimental: E
Engagement Off - Problem Solving High - Motivation On
|
Multicomponent behavioral and educational intervention.
The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation
|
|
Experimental: F
Engagement Off - Problem Solving Low - Motivation On
|
Multicomponent behavioral and educational intervention.
The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation
|
|
Experimental: G
Engagement Off - Problem Solving High - Motivation Off
|
Multicomponent behavioral and educational intervention.
The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation
|
|
Experimental: H
Engagement Off - Problem Solving Low - Motivation Off
|
Multicomponent behavioral and educational intervention.
The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Attempt to Contact a Maternal Depression Resource
Time Frame: 2 Weeks Post-Intervention
|
2 Weeks Post-Intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Intention to Contact a Maternal Depression Resource
Time Frame: 2 Weeks Post-Intervention
|
2 Weeks Post-Intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Erik O Fernandez y Garcia, MD MPH, University of California, Davis
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 800492
- K23MH101157 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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