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

Northwestern University

Status: Completed

Conditions: PostPartum Depression; Perinatal Depression

Treatments: Behavioral: Mothers and Babies Groups

Study type: Interventional

Funder types: Other

Identifiers

NCT02979444

STU00203761

Details and patient eligibility

About

There is considerable evidence that most perinatal women at risk for postpartum depression do not engage in mental health services, even when referred by home visiting (HV) programs, primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be delivered via alternative settings-e.g., HV programs-are essential to prevent the onset of major depression and worsening of depressive symptoms among perinatal women. This Patient Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is more efficacious than usual care (i.e., home visiting without the MB enhancement). It will also examine if MB, when led by paraprofessional home visitors, is not inferior to MB delivered by mental health professionals. The results of this study will inform decision-making by HV programs regarding provision of MB to perinatal women at risk for developing major depression.

Full description

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.

Enrollment: 874 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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874 participants in 3 patient groups

Mothers and Babies Groups Home-Visitor

Experimental group

Description:

Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.

Treatment:

Behavioral: Mothers and Babies Groups

Mothers and Babies Groups Clinician

Experimental group

Description:

Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.

Treatment:

Behavioral: Mothers and Babies Groups

Control

No Intervention group

Description:

Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.