Mental Health DisorderIMPACTNCT06575894
Implementing Mental Health Programs Across Communities in Iowa & Indiana for Transformation
A study testing Adapted Facilitation and Standard Implementation in people with Mental Health Disorder, run by Hackensack Meridian Health at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Disorder
- What is being tested?
- Adapted Facilitation and Standard Implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,750 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Affiliated as staff or volunteer with a home visiting program in Iowa or Indiana at the time of enrollment
- Aged 18 years or older
Who cannot join
- No exclusion criteria.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Department of Health and Human Services
Des Moines, Iowa, 50319
Indiana Department of Health
Indianapolis, Indiana, 46204
About this study
Official title: Can an Evidence-Based Mental Health Intervention be Implemented Into Preexisting Home Visiting Programs Using Implementation Facilitation?
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.
Read the 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 affect the entire family with pregnancy complications and negative outcomes including preterm birth, impaired mother-infant bonding, impaired lactation, substance abuse, divorce, suicide, and infanticide. Despite this, significant gaps persist in the diagnosis and treatment of perinatal depression and anxiety. Preliminary research with stakeholders including community advisory boards, groups underreceiving mental health services, and state departments of health, demonstrates the importance of social support as a mechanism for improving 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 (e.g., 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 (i.e., 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, better access, and further reductions in adverse outcomes for mothers, children, and families.
- Conditions
- Mental Health Disorder
- Being tested
- Adapted Facilitation, Standard Implementation
- Keywords
- perinatal, home visiting, context, ethnography
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted FacilitationBehavioural
Home visiting supervisor trained in adapted facilitation will employ interactive problem-solving focused on supporting the home visitors to implement Mothers and Babies - working with pregnant people, challenges with resources, additional training needs, etc. - based on understanding the individual communities, contexts, and recipients' and home visitors' needs over the course of the project.
Standard ImplementationBehavioural
Standard Mothers and Babies training includes ongoing implementation support from the Mothers and Babies training team
| Study group | Role | What they receive |
|---|---|---|
| HV Supervisor Refused | No intervention | Home visitors outside the trial will receive no implementation support from their supervisors with respect to the Mothers and Babies intervention. |
| Standard Implementation | Active comparator | Control arm home visitors will receive standard Mothers and Babies implementation support from their supervisors. Receives: Behavioral: Standard Implementation |
| Adapted Facilitation | Experimental | Home visitors in the adapted facilitation group will receive standard Mothers and Babies support plus adapted facilitation delivered by home visiting supervisors trained in adapted implementation facilitation. Receives: Behavioral: Adapted Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption
Percent of home visitors who deliver Mothers and Babies intervention to program recipients
Measured: From date of recruitment assessed up to 12 months (3 months postpartum)
Fidelity
Percent of home visitors who deliver all 9 sessions of Mothers and Babies to program recipients
Measured: From date of recruitment assessed up to 12 months (3 months postpartum)
Secondary outcomes (1)
Depressive Symptoms
Program recipient scores on the Edinburgh Postnatal Depression Scale (Scores range from 0-30; a score of more than 10 suggests minor or major depression may be present.)
Measured: From date of recruitment assessed up to 12 months (3 months postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Apr 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pragmatic cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 1,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Elissa Z Faro, PhD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575894
- Sponsor's protocol ID
- 202312148
- Other IDs
- 1R01MH134474-01A1, Pro2025-0522, 28141
- Acronym
- IMPACT
- Status last verified
- Apr 2026
- First submitted
- 22 Aug 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded interview/focus group transcript data will be both preserved and shared through relevant publications or other dissemination (e.g., conference presentations). Interview/focus group/observation transcript data will be deposited with NIMH Data Archive (NDA), located within a broad-use permission group where data will only be accessible to researchers who submit a Data Use Certification (DUC) and who meet the NDA's criteria to request access. The DUC includes terms that prohibit the attempt of reidentification. Survey responses will be both preserved and shared. Aggregate data and codebooks will be shared with relevant publications or by the end of the project period. Aggregate data is a dataset comprised of the consolidation of data relating to multiple survey participants, and therefore cannot be traced back to a specific participant. Respondent identifiers will not be shared. De-identified survey data will also be deposited with NDA.
Publications
Faro EZ, Jones D, Adeagbo M, Cho H, Swartzendruber G, Tabb KM, Tandon SD, Ryckman K. Can an evidence-based mental health intervention be implemented into preexisting home visiting programs using implementation facilitation? Study protocol for a three variable implementation effectiveness context hybrid trial. Implement Sci. 2024 Nov 11;19(1):76. doi: 10.1186/s13012-024-01402-7.
PubMed 39529089
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can an Evidence-Based Mental Health Intervention be Implemented Into Preexisting Home Visiting Programs Using Implementation Facilitation?
- ClinicalTrials.gov ID
- NCT06575894
- Acronym / sponsor ID
- IMPACT / 202312148
- Conditions
- Mental Health Disorder
- Keywords
- perinatal, home visiting, context, ethnography
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,750 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 affect the entire family with pregnancy complications and negative outcomes including preterm birth, impaired mother-infant bonding, impaired lactation, substance abuse, divorce, suicide, and infanticide. Despite this, significant gaps persist in the diagnosis and treatment of perinatal depression and anxiety. Preliminary research with stakeholders including community advisory boards, groups underreceiving mental health services, and state departments of health, demonstrates the importance of social support as a mechanism for improving 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 (e.g., 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 (i.e., 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, better access, and further reductions in adverse outcomes for mothers, children, and families.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- pragmatic cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| HV Supervisor Refused | No intervention | –Home visitors outside the trial will receive no implementation support from their supervisors with respect to the Mothers and Babies intervention. |
| Standard Implementation | Active comparator | Behavioral: Standard ImplementationControl arm home visitors will receive standard Mothers and Babies implementation support from their supervisors. |
| Adapted Facilitation | Experimental | Behavioral: Adapted FacilitationHome visitors in the adapted facilitation group will receive standard Mothers and Babies support plus adapted facilitation delivered by home visiting supervisors trained in adapted implementation facilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Affiliated as staff or volunteer with a home visiting program in Iowa or Indiana at the time of enrollment
- Aged 18 years or older
Key exclusion criteria (1 listed)
- No exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted FacilitationHome visiting supervisor trained in adapted facilitation will employ interactive problem-solving focused on supporting the home visitors to implement Mothers and Babies - working with pregnant people, challenges with resources, additional training needs, etc. - based on understanding the individual communities, contexts, and recipients' and home visitors' needs over the course of the project. | Behavioural | Adapted Facilitation |
| Standard ImplementationStandard Mothers and Babies training includes ongoing implementation support from the Mothers and Babies training team | Behavioural | Standard Implementation |
Primary outcome
Adoption
Time frame: From date of recruitment assessed up to 12 months (3 months postpartum)
Percent of home visitors who deliver Mothers and Babies intervention to program recipients
Fidelity
Time frame: From date of recruitment assessed up to 12 months (3 months postpartum)
Percent of home visitors who deliver all 9 sessions of Mothers and Babies to program recipients
1 secondary outcome
Depressive Symptoms
Time frame: From date of recruitment assessed up to 12 months (3 months postpartum)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Derived from this study: PubMed 39529089Faro EZ, Jones D, Adeagbo M, Cho H, Swartzendruber G, Tabb KM, Tandon SD, Ryckman K. Can an evidence-based mental health intervention be implemented into preexisting home visiting programs using implementation facilitation? Study protocol for a three variable implementation effectiveness context hybrid trial. Implement Sci. 2024 Nov 11;19(1):76. doi: 10.1186/s13012-024-01402-7.
- Individual participant dataSharing planned: Yes. Coded interview/focus group transcript data will be both preserved and shared through relevant publications or other dissemination (e.g., conference presentations). Interview/focus group/observation transcript data will be deposited with NIMH Data Archive (NDA), located within a broad-use permission group where data will only be accessible to researchers who submit a Data Use Certification (DUC) and who meet the NDA's criteria to request access. The DUC includes terms that prohibit the attempt of reidentification. Survey responses will be both preserved and shared. Aggregate data and codebooks will be shared with relevant publications or by the end of the project period. Aggregate data is a dataset comprised of the consolidation of data relating to multiple survey participants, and therefore cannot be traced back to a specific participant. Respondent identifiers will not be shared. De-identified survey data will also be deposited with NDA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elissa Z Faro, PhD principal investigator
Hackensack Meridian Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Facilitation and Standard Implementation in people with Mental Health Disorder, run by Hackensack Meridian Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption (time frame: From date of recruitment assessed up to 12 months (3 months postpartum)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06575894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.