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

NCT05838404 | Recruiting

• 1 other identifier: 2022-1533
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Keywords

Pregnancy; Pregnancy-related anxiety

Outcome Measures

Primary Outcomes (1)

• Pregnancy-specific anxiety

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

  12 weeks

Secondary Outcomes (1)

• Depressive symptoms

  12 weeks

Other Outcomes (2)

• Acceptability

  12 weeks

• Fidelity

  12 weeks.

Study Arms (1)

MOMS on the Bayou Intervention Group

EXPERIMENTAL

Participants complete intervention protocol.

Behavioral: M-O-M-S on the Bayou

Interventions

M-O-M-S on the Bayou BEHAVIORAL

Peer and mentor support and meetings across pregnancy

MOMS on the Bayou Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant
• Below 20 weeks' gestation
• Enrolled in prenatal care

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead

Study Sites (1)

Tulane University

New Orleans, Louisiana, 70112, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Emily Harville, PhD

CONTACT

504-988-7327; eharvill@tulane.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 1, 2023
• Study Start: November 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (1)