Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05838404 |
Other study ID # |
2022-1533 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2023 |
Est. completion date |
July 2025 |
Study information
Verified date |
March 2024 |
Source |
Tulane University |
Contact |
Emily Harville, PhD |
Phone |
504-988-7327 |
Email |
eharvill[@]tulane.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.