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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTulane University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant

Below 20 weeks' gestation

Enrolled in prenatal care

Disqualifiers

Not pregnant

Under age 18

Does not speak English or Spanish

Does not plan to carry to term

Trial design

Design model

Single group

Treatments tested in this trial

  • M-O-M-S on the Bayou

    Behavioral

    Peer and mentor support and meetings across pregnancy

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: MOMS on the Bayou Intervention GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
12 weeks

Secondary outcomes

1

Depressive symptoms

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

Time frame
12 weeks

Other outcomes

1

Acceptability

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
2

Fidelity

Fidelity is measured as the number of sessions attended.

Time frame
12 weeks.

Sponsors and contacts

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