Perinatal DepressionNCT00536159
Medicaid Enhanced Prenatal/Postnatal Services Using a Nurse-Community Health Worker Team
A study testing Medicaid Maternal and Infant Support Services and Nurse-CHW team in people with Perinatal Depression and Stress, run by Michigan State University at 1 site in United States.
Trial summary
Our objective was to test whether there were advantages to Nurse-CHW team home visiting designed to combine the strengths of both visitors, with a focus on maternal stress and mental health, when compared with standard of Community Care (CC) that included professional home visitors in a state-sponsored Medicaid… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Perinatal Depression, Stress, Prenatal Health Risk Behaviors
- What is being tested?
- Medicaid Maternal and Infant Support Services and Nurse-CHW team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 613 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1997to Aug 2000
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medicaid eligible
- residency in the county and no plans to move within 18 months
- at least 16 years of age
- speaks Spanish or English
Who cannot join
- no pre-existing relationship with a home visiting nurse
- no diagnosis or treatment for a pre-existing mental health condition within the last two years
Trial locations and contacts
1 site in 1 country.
United States1 site
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
About this study
Official title: Improving the Health and Development of Low-Income Pregnant Women
Our objective was to test whether there were advantages to Nurse-CHW team home visiting designed to combine the strengths of both visitors, with a focus on maternal stress and mental health, when compared with standard of Community Care (CC) that included professional home visitors in a state-sponsored Medicaid program. We conducted the study under usual community conditions in a population of women eligible for state-sponsored Medicaid programs. We predicted that during pregnancy and infancy, women in the Nurse-CHW team intervention would report 1) less perceived stress; 2) fewer depressive symptoms; and 3) increased levels of psychosocial resources (self-esteem, mastery, and social support) than women in CC. Benefits were expected to be most pronounced for women with low psychosocial resources and high stress at enrollment.
Read the detailed description
Impoverished pregnant and parenting women have greater exposure to environmental stress with adverse effects for their own mental and physical health that may have long term consequences for their children's health and development. The mental health consequences of stress are pervasive in low income pregnant women and mothers with almost half screening positive for depressive symptoms and a quarter meeting diagnostic criteria for major or minor depression. While national home visiting models have demonstrated improvement in health, developmental, and parenting outcomes for women willing to participate, they have had less success in reducing depressive symptoms during pre and postnatal periods, and often programs struggle to engage women with unmet mental health needs.
We conducted a community-based, multi-site, randomized, controlled trial that included longitudinal assessment on five occasions during pregnancy and infancy to determine temporal program effects. We used a CC comparison group because Medicaid insured women in Michigan are eligible for home visiting through enhanced prenatal and infant services, and our goal was to determine if there was any advantage to the team approach when compared to community implementation of the state-sponsored home visiting program.
Pregnant women, who telephoned one of five public clinics in Kent County, Michigan, a county that includes urban (Grand Rapids) and rural areas, were contacted and invited to participate in the trial. We enrolled women considered harder to reach with cultural, language, and literacy barriers to participation and with chronic or current medical problems-populations traditionally served by state-sponsored programs. Participation was not dependent on women coming to a research or health facility, participating in prenatal or child health care or the enhanced services, having reliable transportation, consistent phone service, or stable housing.
- Being tested
- Medicaid Maternal and Infant Support Services, Nurse-CHW team
- Keywords
- nurse-community health worker team, perinatal depression, stress, Medicaid enhanced prenatal programs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicaid Maternal and Infant Support ServicesOther
Enhanced services include home visiting, transportation, psychosocial counseling, multidisciplinary planning, case management, nutritional guidance, and pregnancy and parenting education during pregnancy and infancy. The services are delivered primarily by nurses with occasional visits by social workers or nutritionists. In the county of the study (Kent), women who were assessed were provided intervention services.
Nurse-CHW teamOther
A nurse and two CHWs functioned as a team, using visit and clinical guidelines that detailed expected care. Each team provided services for approximately 50-60 families. While occasional visits were made by both providers, most visits were made by either provider alone. Nurses guided the CHW care, led a multidisciplinary team assessment (with social workers, nutritionists, and others), provided crisis intervention and case management, assessed and managed health problems (including screening for depression and mental health care), and had periodic office visits with prenatal providers. CHWs provided relationship-based support by attempting weekly prenatal contact that alternated phone and face-to-face visits and used peer role modeling and personal empowerment approaches.
| Study group | Role | What they receive |
|---|---|---|
| Community Care | Active comparator | Medicaid eligible/insured pregnant women and their infants are eligible for risk assessment and up to 18 home visits (9/pregnancy and 9/infancy) from community professional providers as part of a state-sponsored enhanced prenatal and postnatal Medicaid program. Receives: Other: Medicaid Maternal and Infant Support Services |
| Nurse-CHW Team | Experimental | Nurse-CHW team provided both nursing care, with additional focus on mental health and stress, and intensive relationship-based support from a CHW similar in characteristics to women served in the context of state-sponsored Medicaid program. Receives: Other: Nurse-CHW team |
What is being measured
The primary outcome is the main question the study is designed to answer.
depressive symptoms
Measured: <24 weeks gestation to 12 months post birth
perceived stress
Measured: <24 weeks gestation to 12 months post birth
mastery
Measured: <24 weeks gestation to 12 months postbirth
self esteem
Measured: <24 weeks gestation to 12 months post birth
social support
Measured: <24 weeks gestation to 12 months postbirth
Secondary outcomes (4)
infant motor, mental development
Measured: 6 and 12 months postbirth
maternal-infant interaction
Measured: 6 and 12 months postbirth
Medicaid (maternal and infant)and program costs
Measured: <24 weeks gestation to 12 months
health risk behaviors (smoking, drug, alcohol)
Measured: <24 weeks gestation to 12 months postbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startJan 1997
- Study completionAug 2000
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 Perinatal DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health West
- Investigators
- Lee Anne Roman, MSN, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536159
- Sponsor's protocol ID
- R50 MC00045-04 R2
- Status last verified
- Sep 2007
- First submitted
- 18 Sep 2007
- Last updated
- 27 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Roman LA, Lindsay JK, Moore JS, Duthie PA, Peck C, Barton LR, Gebben MR, Baer LJ. Addressing mental health and stress in Medicaid-insured pregnant women using a nurse-community health worker home visiting team. Public Health Nurs. 2007 May-Jun;24(3):239-48. doi: 10.1111/j.1525-1446.2007.00630.x.
PubMed 17456125
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Health and Development of Low-Income Pregnant Women
- ClinicalTrials.gov ID
- NCT00536159
- Acronym / sponsor ID
- R50 MC00045-04 R2
- Keywords
- nurse-community health worker team, perinatal depression, stress, Medicaid enhanced prenatal programs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Corewell Health West
- Study start
- Jan 1997
- Study completion
- Aug 2000 (actual)
- First posted
- 27 Sep 2007 (estimated)
- 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.
Our objective was to test whether there were advantages to Nurse-CHW team home visiting designed to combine the strengths of both visitors, with a focus on maternal stress and mental health, when compared with standard of Community Care (CC) that included professional home visitors in a state-sponsored Medicaid program. We conducted the study under usual community conditions in a population of women eligible for state-sponsored Medicaid programs. We predicted that during pregnancy and infancy, women in the Nurse-CHW team intervention would report 1) less perceived stress; 2) fewer depressive symptoms; and 3) increased levels of psychosocial resources (self-esteem, mastery, and social support) than women in CC. Benefits were expected to be most pronounced for women with low psychosocial resources and high stress at enrollment.
Detailed description
Impoverished pregnant and parenting women have greater exposure to environmental stress with adverse effects for their own mental and physical health that may have long term consequences for their children's health and development. The mental health consequences of stress are pervasive in low income pregnant women and mothers with almost half screening positive for depressive symptoms and a quarter meeting diagnostic criteria for major or minor depression. While national home visiting models have demonstrated improvement in health, developmental, and parenting outcomes for women willing to participate, they have had less success in reducing depressive symptoms during pre and postnatal periods, and often programs struggle to engage women with unmet mental health needs.
We conducted a community-based, multi-site, randomized, controlled trial that included longitudinal assessment on five occasions during pregnancy and infancy to determine temporal program effects. We used a CC comparison group because Medicaid insured women in Michigan are eligible for home visiting through enhanced prenatal and infant services, and our goal was to determine if there was any advantage to the team approach when compared to community implementation of the state-sponsored home visiting program.
Pregnant women, who telephoned one of five public clinics in Kent County, Michigan, a county that includes urban (Grand Rapids) and rural areas, were contacted and invited to participate in the trial. We enrolled women considered harder to reach with cultural, language, and literacy barriers to participation and with chronic or current medical problems-populations traditionally served by state-sponsored programs. Participation was not dependent on women coming to a research or health facility, participating in prenatal or child health care or the enhanced services, having reliable transportation, consistent phone service, or stable housing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Care | Active comparator | Other: Medicaid Maternal and Infant Support ServicesMedicaid eligible/insured pregnant women and their infants are eligible for risk assessment and up to 18 home visits (9/pregnancy and 9/infancy) from community professional providers as part of a state-sponsored enhanced prenatal and postnatal Medicaid program. |
| Nurse-CHW Team | Experimental | Other: Nurse-CHW teamNurse-CHW team provided both nursing care, with additional focus on mental health and stress, and intensive relationship-based support from a CHW similar in characteristics to women served in the context of state-sponsored Medicaid program. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Medicaid eligible
- residency in the county and no plans to move within 18 months
- at least 16 years of age
- speaks Spanish or English
Key exclusion criteria (2 listed)
- no pre-existing relationship with a home visiting nurse
- no diagnosis or treatment for a pre-existing mental health condition within the last two years
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 |
|---|---|---|
| Medicaid Maternal and Infant Support ServicesEnhanced services include home visiting, transportation, psychosocial counseling, multidisciplinary planning, case management, nutritional guidance, and pregnancy and parenting education during pregnancy and infancy. The services are delivered primarily by nurses with occasional visits by social workers or nutritionists. In the county of the study (Kent), women who were assessed were provided intervention services. | Other | Community Care |
| Nurse-CHW teamA nurse and two CHWs functioned as a team, using visit and clinical guidelines that detailed expected care. Each team provided services for approximately 50-60 families. While occasional visits were made by both providers, most visits were made by either provider alone. Nurses guided the CHW care, led a multidisciplinary team assessment (with social workers, nutritionists, and others), provided crisis intervention and case management, assessed and managed health problems (including screening for depression and mental health care), and had periodic office visits with prenatal providers. CHWs provided relationship-based support by attempting weekly prenatal contact that alternated phone and face-to-face visits and used peer role modeling and personal empowerment approaches. | Other | Nurse-CHW Team |
Primary outcome
depressive symptoms
Time frame: <24 weeks gestation to 12 months post birth
perceived stress
Time frame: <24 weeks gestation to 12 months post birth
mastery
Time frame: <24 weeks gestation to 12 months postbirth
self esteem
Time frame: <24 weeks gestation to 12 months post birth
social support
Time frame: <24 weeks gestation to 12 months postbirth
4 secondary outcomes
infant motor, mental development
Time frame: 6 and 12 months postbirth
maternal-infant interaction
Time frame: 6 and 12 months postbirth
Medicaid (maternal and infant)and program costs
Time frame: <24 weeks gestation to 12 months
health risk behaviors (smoking, drug, alcohol)
Time frame: <24 weeks gestation to 12 months postbirth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2007.
- Background: PubMed 17456125Roman LA, Lindsay JK, Moore JS, Duthie PA, Peck C, Barton LR, Gebben MR, Baer LJ. Addressing mental health and stress in Medicaid-insured pregnant women using a nurse-community health worker home visiting team. Public Health Nurs. 2007 May-Jun;24(3):239-48. doi: 10.1111/j.1525-1446.2007.00630.x.
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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. This study is not recruiting at the moment.
Lee Anne Roman, MSN, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medicaid Maternal and Infant Support Services and Nurse-CHW team in people with Perinatal Depression and Stress, run by Michigan State University at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 27 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
depressive symptoms (time frame: <24 weeks gestation to 12 months post birth). The study lists 5 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 NCT00536159, 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 27 Sep 2007.