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Motivating Our Mothers 2 (MOM2)

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ClinicalTrials.gov Identifier: NCT02938598
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Davis

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Depression Maternal Care Patterns Behavioral: Maternal Depression Education and Care-Seeking Motivation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Optimizing a Pediatric Intervention to Increase Maternal Depression Care-Seeking
Study Start Date : October 2016
Actual Primary Completion Date : May 23, 2019
Actual Study Completion Date : May 23, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
Engagement On - Problem Solving High - Motivation On
Behavioral: Maternal Depression Education and Care-Seeking Motivation
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
Behavioral: Maternal Depression Education and Care-Seeking Motivation
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
Behavioral: Maternal Depression Education and Care-Seeking Motivation
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
Behavioral: Maternal Depression Education and Care-Seeking Motivation
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
Behavioral: Maternal Depression Education and Care-Seeking Motivation
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
Behavioral: Maternal Depression Education and Care-Seeking Motivation
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
Behavioral: Maternal Depression Education and Care-Seeking Motivation
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
Behavioral: Maternal Depression Education and Care-Seeking Motivation
Multicomponent behavioral and educational intervention. The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation




Primary Outcome Measures :
  1. Attempt to Contact a Maternal Depression Resource [ Time Frame: 2 Weeks Post-Intervention ]

Secondary Outcome Measures :
  1. Intention to Contact a Maternal Depression Resource [ Time Frame: 2 Weeks Post-Intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938598


Locations
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United States, California
University of California Davis, Department of Pediatrics
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Erik O Fernandez y Garcia, MD MPH University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02938598     History of Changes
Other Study ID Numbers: 800492
K23MH101157 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of California, Davis:
maternal depression
pediatric-based maternal depression screening
maternal health services

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders