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Motivating Our Mothers 2 (MOM2)

Primary Purpose

Depression, Maternal Care Patterns

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maternal Depression Education and Care-Seeking Motivation
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring maternal depression, pediatric-based maternal depression screening, maternal health services

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Davis, Department of Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A

B

C

D

E

F

G

H

Arm Description

Engagement On - Problem Solving High - Motivation On

Engagement On - Problem Solving Low - Motivation On

Engagement On - Problem Solving High - Motivation Off

Engagement On - Problem Solving Low - Motivation Off

Engagement Off - Problem Solving High - Motivation On

Engagement Off - Problem Solving Low - Motivation On

Engagement Off - Problem Solving High - Motivation Off

Engagement Off - Problem Solving Low - Motivation Off

Outcomes

Primary Outcome Measures

Attempt to Contact a Maternal Depression Resource

Secondary Outcome Measures

Intention to Contact a Maternal Depression Resource

Full Information

First Posted
October 17, 2016
Last Updated
April 8, 2021
Sponsor
University of California, Davis
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02938598
Brief Title
Motivating Our Mothers 2
Acronym
MOM2
Official Title
Optimizing a Pediatric Intervention to Increase Maternal Depression Care-Seeking
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
May 23, 2019 (Actual)
Study Completion Date
May 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Maternal Care Patterns
Keywords
maternal depression, pediatric-based maternal depression screening, maternal health services

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Engagement On - Problem Solving High - Motivation On
Arm Title
B
Arm Type
Experimental
Arm Description
Engagement On - Problem Solving Low - Motivation On
Arm Title
C
Arm Type
Experimental
Arm Description
Engagement On - Problem Solving High - Motivation Off
Arm Title
D
Arm Type
Experimental
Arm Description
Engagement On - Problem Solving Low - Motivation Off
Arm Title
E
Arm Type
Experimental
Arm Description
Engagement Off - Problem Solving High - Motivation On
Arm Title
F
Arm Type
Experimental
Arm Description
Engagement Off - Problem Solving Low - Motivation On
Arm Title
G
Arm Type
Experimental
Arm Description
Engagement Off - Problem Solving High - Motivation Off
Arm Title
H
Arm Type
Experimental
Arm Description
Engagement Off - Problem Solving Low - Motivation Off
Intervention Type
Behavioral
Intervention Name(s)
Maternal Depression Education and Care-Seeking Motivation
Intervention Description
Multicomponent behavioral and educational intervention. The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation
Primary Outcome Measure Information:
Title
Attempt to Contact a Maternal Depression Resource
Time Frame
2 Weeks Post-Intervention
Secondary Outcome Measure Information:
Title
Intention to Contact a Maternal Depression Resource
Time Frame
2 Weeks Post-Intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik O Fernandez y Garcia, MD MPH
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis, Department of Pediatrics
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Motivating Our Mothers 2

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