Recruiting

Mental Health

Sponsor:

Tulane University

Code:

NCT05838404

Conditions

Anxiety

Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

M-O-M-S on the Bayou

Study Details

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

Study ID

NCT05838404

Start date

Nov 1, 2023

Status verified date

Sep, 2025

Completion date

Nov 30, 2025

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

240 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: MOMS on the Bayou Intervention Group

Participants complete intervention protocol.

Interventions

M-O-M-S on the Bayou

Peer and mentor support and meetings across pregnancy

Primary outcome measure

  • Pregnancy-specific anxiety [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Tulane University

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Emily Harville

504-988-7327

Andrea Meyer

504-988-8803

More Information

Sponsor

Tulane University

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Keywords

  • Pregnancy
  • Pregnancy-related anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2025-09-24.