Ignite Creation Date:
2024-05-06 @ 9:24 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02979444
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2016-11-29
Brief Title:
Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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-eg 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 ie 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
Detailed 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 ie home visiting without MB on patient-reported outcomes including depressive symptoms quality of life parenting practices engagement in pleasant activities and relationship with ones 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 eg race ethnicity first-time mother andor geographic type of home visiting HV program ie 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 ie pregnancy until childs 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 eg 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 eg 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
Aim 1 is to conduct a superiority trial that compares the efficacy of MB delivered by paraprofessional home visitors versus usual care ie home visiting without MB on patient-reported outcomes including depressive symptoms quality of life parenting practices engagement in pleasant activities and relationship with ones 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 eg race ethnicity first-time mother andor geographic type of home visiting HV program ie 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 ie pregnancy until childs 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 eg 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None