Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575894
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Implementing Mental Health Programs Across Communities in Iowa Indiana for Transformation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Can an Evidence-Based Mental Health Intervention be Implemented Into Preexisting Home Visiting Programs Using Implementation Facilitation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT
Brief Summary:
Depression and anxiety during and after pregnancy are common medical complications contributing to a rising maternal mortality rate Home visiting programs can offer evidence-based interventions to improve mental health outcomes for a vulnerable pregnant population however barriers remain to achieving the full potential of these interventions Our work will explore the impact of context on the implementation of a mental health intervention to provide action-based and impactful data that focuses on the lived experiences of the diverse populations served by home visiting programs in Iowa and Indiana
Detailed Description:
Perinatal mental health conditions are the most common complication of pregnancy and childbirth 1 in 8 women When left untreated perinatal depression and anxiety adversely affects the entire family with pregnancy complications and negative outcomes including preterm birth impaired mother-infant bonding impaired lactation substance abuse divorce suicide and infanticide Significant disparities persist in the diagnosis and treatment of perinatal depression and anxiety and these inequities are often intersectional Preliminary research with stakeholders including community advisory boards underrepresented and minority birthing people and state departments of health demonstrates the importance of social support as a mechanism for reducing disparities in perinatal depression particularly in rural geographies Home visiting programs HVPs can provide the social support needed to improve mental health outcomes in pregnant and postpartum women
Using the strategy of implementation facilitation our proposed study will engage multilevel stakeholders eg policymakers front-line implementers and intervention recipients to adapt facilitation to integrate a maternal mental health intervention across two midwestern rural states Iowa and Indiana with multiple HVP models Given the complexity and heterogeneity of the contexts in which Mothers and Babies will be integrated a three variable hybrid implementation-effectiveness-context trial will test the adapted facilitation strategy compared with implementation as usual ie standard education and will assess contextual factors related to the outcomes Using an evidence-based implementation strategy that tailors implementation delivery to the needs of the specific populations and context may improve fidelity and adoption particularly in rural states where residents have limited access to care
The immediate impact of this research will be to show whether adapted facilitation can improve the uptake and fidelity of a maternal mental health intervention like Mothers and Babies across multiple HVP models and thus positively affect depressive symptoms and perceived stress of recipients Further our implementation protocol can be used by other states to better integrate other evidence-based interventions into public health programs leading to further improvements in maternal mental health more equitable outcomes and further reductions in adverse outcomes for mothers children and families
Using the strategy of implementation facilitation our proposed study will engage multilevel stakeholders eg policymakers front-line implementers and intervention recipients to adapt facilitation to integrate a maternal mental health intervention across two midwestern rural states Iowa and Indiana with multiple HVP models Given the complexity and heterogeneity of the contexts in which Mothers and Babies will be integrated a three variable hybrid implementation-effectiveness-context trial will test the adapted facilitation strategy compared with implementation as usual ie standard education and will assess contextual factors related to the outcomes Using an evidence-based implementation strategy that tailors implementation delivery to the needs of the specific populations and context may improve fidelity and adoption particularly in rural states where residents have limited access to care
The immediate impact of this research will be to show whether adapted facilitation can improve the uptake and fidelity of a maternal mental health intervention like Mothers and Babies across multiple HVP models and thus positively affect depressive symptoms and perceived stress of recipients Further our implementation protocol can be used by other states to better integrate other evidence-based interventions into public health programs leading to further improvements in maternal mental health more equitable outcomes and further reductions in adverse outcomes for mothers children and families
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