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M-O-M-S on the Bayou: Implementation of an Intervention for Mental Health in Pregnancy

Primary Purpose

Anxiety, Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
M-O-M-S on the Bayou
Sponsored by
Tulane University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring Pregnancy, Pregnancy-related anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Pregnant Below 20 weeks' gestation Enrolled in prenatal care Exclusion Criteria: Not pregnant Under age 18 Does not speak English or Spanish Does not plan to carry to term Does not plan to remain in the study area through pregnancy Fetal defects likely to lead to death or extensive hospitalization postpartum

Sites / Locations

  • Tulane University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MOMS on the Bayou Intervention Group

Arm Description

Participants complete intervention protocol.

Outcomes

Primary Outcome Measures

Pregnancy-specific anxiety
Score on the Lederman Prenatal Self-Evaluation Questionnaire (PSEQ), Scale of 1-4; 1 = worse outcome; 4 = better outcome.

Secondary Outcome Measures

Depressive symptoms
Score on Edinburgh Postnatal Depression Scale (EPDS), Scale of 1-4; 1 = better outcome; 4 = worse outcome.

Full Information

First Posted
April 10, 2023
Last Updated
August 17, 2023
Sponsor
Tulane University
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1. Study Identification

Unique Protocol Identification Number
NCT05838404
Brief Title
M-O-M-S on the Bayou: Implementation of an Intervention for Mental Health in Pregnancy
Official Title
M-O-M-S on the Bayou: Implementation of an Intervention for Mental Health in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tulane University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Disasters have negative effects in the short term (physical trauma, adverse environmental exposures, and unstable housing) and the long term (relocation, changes in family functioning, and negative economic effects), which interact with social determinants to worsen health among the most vulnerable women, infants, and communities. Trauma and severe stress are directly linked to pregnancy complications, and raise blood pressure during pregnancy, alter stress hormones, and increase vulnerability to infection, all of which predispose to reduced fetal growth and preterm birth. Disasters also worsen mental health, and depression during pregnancy and postpartum, for instance, is associated with worse physical health during pregnancy, maternal impairment, poorer quality parenting, negative child behavior, and poorer infant cognitive development.The goal of this intervention is to improve mental health in pregnant women living in a disaster-affected region. The main questions this intervention aims to answer are: Assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, and sustainability) of a pilot intervention in a disaster recovery environment. Assess the effectiveness of the M-O-M-S pilot intervention in a disaster recovery environment. The study will recruit pregnant women in areas that have experienced a natural disaster. Women will be recruited in early pregnancy and attend a series of classes on the cognitive and relationship changes of pregnancy and motherhood, and mental preparation for labor, led by a "mentor," a mother who has experienced pregnancy, labor, and motherhood.
Detailed Description
The M-O-M-S™ (Mentors Offering Maternal Support) intervention is based in a theoretical framework addressing the major transitions that occur with pregnancy and close relationship processes. Weis et al. found that community esteem-building support, focused in first and second trimester, decreased anxiety associated with pregnancy and maternal adaptation. The M-O-M-S™ intervention was specifically designed to address pregnancy-specific anxiety (inclusive of depressive symptoms), concerns related to family/partner relationships, and provide esteem-building peer support, with each session directly aligned to specific aspects of anxiety and depression pertinent to the point in pregnancy for the women. Women are recruited in early pregnancy and attend a series of classes on the cognitive and relationship changes of pregnancy and motherhood, and mental preparation for labor, led by a "mentor", a mother who has experienced pregnancy, labor, and motherhood. Up to 400 subjects will be recruited, with a goal of 240 completing the study. Each group will consist of 15-20 recruits, assuming a degree of attrition that will lead to group sizes of 10-12. The outcome measures will be compared between the intervention and control data and linear regression (with adjustment for partial clustering) used to adjust for differences in participant characteristics. Given an estimated effect size and variance (both pre-post and intervention-control) from previous trials, 240 participants gives good power for reasonable effect sizes for both the pre-post analysis and intervention-control analyses incorporating a design (cluster) effect. Recruitment will take place at ob/gyn practices, WIC clinics, health units, and at community sites. Clinicians will be informed of the intervention and asked to encourage their patients to participate. They will also refer potential participants and provide flyers to interested women. Study staff will also attend the clinics on days when a large number of prenatal visits are scheduled, and clinic staff will inform them who can be approached as a potential participant. Flyers and posters will also be provided to participating clinics, and participants can self-refer. Participants will be contacted via the method they indicate they prefer. Participants will attend 6 group meetings lasting 1 hr. every other week. These sessions are aimed at decreasing pregnancy concerns and building coping skills through supportive relationships with experienced local mothers and the other participants in the group. The meetings are closed group sessions. Participants also receive a "Birth of a Mother" manual designed to guide open discussion during the course of the sessions. In addition, participants will complete questionnaires at baseline and at the end of the intervention about their mental health, experience of the intervention, and disaster experience.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
Pregnancy, Pregnancy-related anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MOMS on the Bayou Intervention Group
Arm Type
Experimental
Arm Description
Participants complete intervention protocol.
Intervention Type
Behavioral
Intervention Name(s)
M-O-M-S on the Bayou
Intervention Description
Peer and mentor support and meetings across pregnancy
Primary Outcome Measure Information:
Title
Pregnancy-specific anxiety
Description
Score on the Lederman Prenatal Self-Evaluation Questionnaire (PSEQ), Scale of 1-4; 1 = worse outcome; 4 = better outcome.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
Score on Edinburgh Postnatal Depression Scale (EPDS), Scale of 1-4; 1 = better outcome; 4 = worse outcome.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Acceptability
Description
Acceptability is assessed with the Acceptability of Intervention Measures (AIM) (Weiner BJ, Lewis CC, Stanick C, et. al.); Scale of 1-5; 1 = worse outcome; 5 = better outcome.
Time Frame
12 weeks
Title
Fidelity
Description
Fidelity is measured as the number of sessions attended.
Time Frame
12 weeks.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant Below 20 weeks' gestation Enrolled in prenatal care Exclusion Criteria: Not pregnant Under age 18 Does not speak English or Spanish Does not plan to carry to term Does not plan to remain in the study area through pregnancy Fetal defects likely to lead to death or extensive hospitalization postpartum
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Harville, PhD
Phone
504-988-7327
Email
eharvill@tulane.edu
Facility Information:
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Harville
Phone
504-988-7327
First Name & Middle Initial & Last Name & Degree
Andrea Meyer
Phone
504-988-8803

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data from the intervention will be provided to the Gulf Research Program.
IPD Sharing Time Frame
No later than two years after the end of the final participant follow-up or one year after the main paper of the project has been published, whichever comes first.
IPD Sharing Access Criteria
Participant confidentiality is paramount and some topics (such as mental and reproductive health) are sensitive, so identifiers and any other data leading to possible deductive disclosure (such as small cell sizes) will be removed before provision to GRP.
IPD Sharing URL
https://grp.griidc.org/

Learn more about this trial

M-O-M-S on the Bayou: Implementation of an Intervention for Mental Health in Pregnancy

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