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 volunteersQualifiers
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
Single group
Treatments tested in this trial
M-O-M-S on the Bayou
BehavioralPeer and mentor support and meetings across pregnancy
Treatment groups
Trial outcomes
Primary outcomes
Pregnancy-specific anxiety
Score on the Lederman Prenatal Self-Evaluation Questionnaire (PSEQ), Scale of 1-4; 1 = worse outcome; 4 = better outcome.
Secondary outcomes
Depressive symptoms
Score on Edinburgh Postnatal Depression Scale (EPDS), Scale of 1-4; 1 = better outcome; 4 = worse outcome.
Other outcomes
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.
Fidelity
Fidelity is measured as the number of sessions attended.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.