Clinical trial NCT04019977: Effects of Early Community Services on Child and Family Development
Official title: Effects of Early Community Services on Child and Family Development
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Child Development
Keywords: Nurse Home Visiting
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: LifeBridge Health
First posted: 2019-07-15
Enrollment: 277
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the current study is to evaluate the effects on early child development of early community services, including a brief nurse home visiting program. Investigators hypothesize that nurse home visiting program participants will be significantly different than non- nurse home visiting program participants on the following child and family outcomes: (a) (reduced) infant emergency room use and overnight hospital stays; (b) (increased) family use of community resources and (higher quality) child care; (c) (increased) maternal wellbeing; and (d) (increased) quality of the home environment, including home safety and supportive parenting by both parents. The study will also explore long-term differences between the nurse home visiting program recipients and non-recipients in (a) rates of official investigations for child maltreatment and (b) two indicators of early educational achievement: kindergarten readiness scores and rates of kindergarten attendance.

Detailed description: The purpose of the current study is to evaluate the effects on child and family development of early community services, including a brief nurse home visiting program. The proposed study will be conducted in partnership with the brief nurse home visiting program and Sinai Hospital, both located in Baltimore, MD. For the purposes of this study, Sinai Hospital will serve as the community/catchment area. Nurse home visitors enroll new mothers into the nurse home visiting program while they are still in the hospital/maternity ward. When the current study officially begins, nurse home visitors will recruit new mothers into the nurse home visiting program every other day only (on odd dates). Research staff will recruit all Baltimore City residents who give birth at Sinai Hospital, regardless of odd/even birth date, while they are still in the hospital/maternity ward.

Eligibility criteria: Inclusion Criteria:

* Mother and Infant are Baltimore City Residents
* Mother gave birth to infant at Sinai Hospital in Baltimore, MD beginning approximately July 15, 2019
* Mother speaks English

Exclusion Criteria:

* Mother and Infant are not Baltimore City Residents
* Mother did not give birth to infant at Sinai Hospital in Baltimore, MD beginning approximately July 15, 2019
* Mother does not speak English

Primary outcomes:
measure: Study-specific Structured Maternal Report Interview on Infant Emergency Room Use
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Data Collection From Records on Infant Emergency Room Use
timeFrame: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination
measure: Study-specific Structured Maternal Report Interview on Number of Infant Overnight Hospital Stays
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Data Collection From Records on Infant Overnight Hospital Stays
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Study-specific Structured Maternal Report Interview on Family Use of Community Resources
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Maternal Wellbeing as Assessed Using the Parenting Stress Index
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Maternal Social Support as Assessed Using The Social Provisions Scale
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Maternal Wellbeing as Assessed Using the Edinburgh Postpartum Depression Scale
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Maternal Wellbeing as Assessed Using the Generalized Anxiety Disorder (GAD-7)
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Home Safety as Assessed Using H.O.M.E.
timeFrame: Planned collection: at/around the time infant turned 6 months old; As this is an in-home observational measure only and all in-home data collection was halted due to COVID-related precautions, we do not have data for the H.O.M.E.
measure: Home Quality as Assessed Using H.O.M.E.
timeFrame: Planned collection: at/around the time infant turned 6 months old; As this is an in-home measure only and all in-home data collection was halted due to COVID-related precautions, we do not have data for the H.O.M.E.
measure: Study-specific Structured Maternal Report Interview on Father's Supportive Parenting
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Parenting Indicators (Discipline)
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Study-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating System
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Study-specific Structured Maternal Report Interview on Infant Immunizations
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Study-specific Structured Maternal Report Interview on Infant Well-baby Visits
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Study-specific Structured Maternal Report Interview on the Number of Community Resources Family Uses
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Secondary outcomes:
measure: Data Collection From Records of Rates of Official Investigations for Child Maltreatment
timeFrame: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination
measure: Maternal Wellbeing as Assessed Using the Adult Attachment Style (AAS)
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Maternal Wellbeing as Assessed Using the Adverse Childhood Experiences (ACEs)
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Neighborhood Quality as Assessed Using The Neighborhood Collective Efficacy
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
measure: Study-specific Structured Maternal Report Interview on Transportation
timeFrame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Other outcomes:
measure: Data Collection From Records of Early Educational Achievement: Kindergarten Readiness Scores, Exploratory
timeFrame: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination
measure: Data Collection From Records of Early Educational Achievement: Rates of Kindergarten Attendance, Exploratory
timeFrame: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination
Locations:
city: Baltimore
country: United States
facility: UMaryland
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital
state: Maryland
Study officials:
affiliation: University of Maryland
name: Lisa J Berlin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dodge KA, Goodman WB, Murphy RA, O'Donnell K, Sato J. Randomized controlled trial of universal postnatal nurse home visiting: impact on emergency care. Pediatrics. 2013 Nov;132 Suppl 2(Suppl 2):S140-6. doi: 10.1542/peds.2013-1021M.
citation: Dodge KA, Goodman WB, Murphy RA, O'Donnell K, Sato J, Guptill S. Implementation and randomized controlled trial evaluation of universal postnatal nurse home visiting. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S136-43. doi: 10.2105/AJPH.2013.301361. Epub 2013 Dec 19.