Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression

Study Aims:

Aim #1 is to conduct a superiority trial that compares the efficacy of MB delivered by
paraprofessional home visitors versus usual care (i.e., home visiting without MB) on
patient-reported outcomes, including depressive symptoms, quality of life, parenting
practices, engagement in pleasant activities, and relationship with one's partner.

Aim #2 is to conduct a non-inferiority trial that compares the effectiveness of MB delivered
by (a) mental health clinicians versus (b) paraprofessional home visitors.

Aim #3 is to evaluate whether effectiveness of the two versions of MB (clinician led vs.
paraprofessional home visitor led) varies according to patient characteristics (e.g., race,
ethnicity, first-time mother, and/or geographic type of home visiting (HV) program (i.e.,
urban vs. rural).

Aim #4 is to examine the feasibility and acceptability of MB delivered by paraprofessional
home visitors and mental health clinicians.

Postpartum depression is a serious mental health disorder that poses significant health and
mental health risks for mothers and their infants. Research suggests that prevalence rates of
postpartum depression are higher among low-income women than among middle-or high-income
women. There is also consistent evidence that low-income women are less likely to receive
mental health services in the perinatal (i.e., pregnancy until child's first birthday) period
than their more affluent counterparts due to a variety of factors including stigma related to
mental health service use and lack of access to community-based mental health providers.
Postpartum depression is a particularly serious problem for low-income women, as it has the
potential to create two generations of suffering, for both mother and child. It is estimated
that over 10% of low-income infants have a mother who has major depression and more than 50%
have a mother with some depressive symptoms. Postpartum depression has negative consequences
for maternal parenting practices. Compared with women not suffering from postpartum
depression, depressed women tend to be less positive, less spontaneous, and less responsive
with their infants. Postpartum depression has been linked to developmental delays among
infants of depressed mothers, including social interaction difficulties, attachment
insecurity, and cognitive impairments.

Home visiting (HV) programs that provide services to perinatal women are one of the largest
avenues through which perinatal women come to the attention of service providers, making HV a
unique and viable setting for delivering mental health services. Although professional HV
models exist (e.g., Nurse-Family Partnership), most HV programs in the United States use
paraprofessionals. Previously, study investigators have established the efficacy of a
group-based intervention —the Mothers and Babies (MB) Course—in preventing the onset of
postpartum depression and reducing depressive symptoms when led by mental health
professionals. However, to date there are no interventions led by non-health or non-mental
health professionals that have demonstrated efficacy in preventing the onset and worsening of
postpartum depression among low-income women. This project attempts to fill this notable gap.

The investigators will conduct a cluster randomized trial in which HV clients receive either
a) MB delivered by mental health professionals, b) MB delivered by paraprofessional home
visitors, or c) usual home visiting services. This study design will allow the investigators
to conduct a superiority trial that compares the efficacy of MB delivered by paraprofessional
home visitors versus usual care. A superiority trial will allow the investigators to generate
efficacy data on MB delivered by paraprofessional home visitors. The study design will also
allow the investigators to conduct a non-inferiority trial that compares the effectiveness of
MB delivered by mental health professionals versus paraprofessional home visitors. Should the
investigators find that paraprofessional home visitors are not inferior to mental health
professionals in delivering the intervention, HV programs throughout the United States will
be able to implement the MB Course with paraprofessional home visitors—an approach that is
considerably more efficient and cost-effective than employing mental health professionals.

This study was born out of community stakeholders' need and desire for a low-cost
intervention that could prevent the onset and worsening of depression among low-income women
enrolled in HV programs. Maternal depression is an enormous challenge facing HV programs.
However, there is consistent evidence that low-income women exhibiting depressive
symptoms—including women enrolled in HV programs—do not access mental health treatment in the
community. Lack of available mental health professionals, stigma in seeking mental health
services, and logistical challenges (e.g., childcare, transportation) are a few of the
barriers faced by perinatal women seeking mental health services. For those clients who do
access services, most perinatal women are likely to receive pharmacological treatments,
despite the fact that the vast majority of perinatal women prefer non-pharmacologic
interventions.

HV programs are ideal settings for delivering mental health care to perinatal women because
their mission is not stigmatizing and HV programs tend to be trusted entities in the
communities they serve. However, there is not yet an evidence-based intervention that can be
delivered by paraprofessionals (such as home visitors), thereby limiting HV programs'
capacity to meet the needs of their clients needing mental health services.

Inclusion Criteria:

- The investigators will enroll only pregnant women in this study, given that the
Mothers and Babies Course is delivered prenatally as a postpartum depression
prevention intervention. The investigators will offer participation to prenatal home
visiting clients, ages 16 and older, knowing the client base for home visiting
programs includes pregnant teens.

Exclusion Criteria:

- Women with high-risk medical and pregnancy conditions will be excluded since this may
preclude women from regularly attending intervention sessions. The investigators will
not exclude women based on race/ethnicity or based on demographic characteristics
other than the ability to speak English or Spanish.