NCT04019977

Effects of Early Community Services on Child and Family Development

Terminated NA Results posted Last updated 21 February 2025

What this trial tests

NA trial testing Nurse Home Visiting Program in Child Development in 277 participants. Terminated before completion.

Timeline

18 July 2019

Primary endpoint
29 September 2020

19 July 2021

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	277
Start date	18 July 2019
Primary completion	29 September 2020
Estimated completion	19 July 2021
Sites	2 locations across United States

Drugs / interventions tested

• Nurse Home Visiting Program

Conditions studied

• Child Development — all drugs for Child Development →

Sponsor

University of Maryland, Baltimore

Who can join

Eligibility, female only, with Child Development. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Study-specific Structured Maternal Report Interview on Infant Emergency Room Use Primary · 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

maternal report of infant emergency room use during study-specific structured interview, i.e.: Since you came home from the hospital after birth, has the baby had to go to the emergency room or emergency department for an illness, injury, or emergency?

Group	Value	95% CI
Infant ER Visit	20
Infant ER Visit	132

Study-specific Structured Maternal Report Interview on Number of Infant Overnight Hospital Stays Primary · 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

maternal report of number of infant overnight hospital stays during study-specific structured interview, i.e.: Since you came home from the hospital after birth, has the baby stayed overnight in the hospital for an illness, injury, or emergency? If yes, how many times?

Group	Value	95% CI
Infant ER Visit	7
Infant ER Visit	145

Data Collection From Records on Infant Overnight Hospital Stays Primary · 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

records from Sinai Hospital and/or the Maryland Department of Health indicating number of overnight hospital stays

Group	Value	95% CI
Completed Interview	0.05	± 0.21

Study-specific Structured Maternal Report Interview on Family Use of Community Resources Primary · 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

Mothers were asked if they use the following services (yes/no): Food Stamps, Special Supplemental Nutrition Program for Women, Infants and Children (WIC), Supplemental Security Income (SSI), Work First- Family Cash Assistance, Medicaid (for the mother) or State Children's Health Insurance Program (S-CHIP) for child, Private health insurance, Job seeking assistance, Transportation assistance, Shelter/housing assistance, Food assistance, Clothing assistance, Furniture assistance, Heating/cooling assistance, Family planning clinic, Breastfeeding support, Mental health counseling, Substance use su

Group	Value	95% CI
Completed Interview	3.99	± 2.24

Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.) Primary · 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

Mothers were asked if they use the following services (yes/no): Food Stamps, Special Supplemental Nutrition Program for Women, Infants and Children (WIC), Supplemental Security Income (SSI), Work First- Family Cash Assistance, Medicaid (for the mother) or State Children's Health Insurance Program (S-CHIP) for child, Private health insurance, Job seeking assistance, Transportation assistance, Shelter/housing assistance, Food assistance, Clothing assistance, Furniture assistance, Heating/cooling assistance, Family planning clinic, Breastfeeding support, Mental health counseling, Substance use su

SNAP

Group	Value	95% CI
Completed Interview	61
Completed Interview	91

WIC

Group	Value	95% CI
Completed Interview	89
Completed Interview	63

SSI

Group	Value	95% CI
Completed Interview	2
Completed Interview	150

TCA

Group	Value	95% CI
Completed Interview	17
Completed Interview	135

Medicaid

Group	Value	95% CI
Completed Interview	75
Completed Interview	77

SCHIP

Group	Value	95% CI
Completed Interview	96
Completed Interview	56

Private health insurance

Group	Value	95% CI
Completed Interview	74
Completed Interview	78

Job services

Group	Value	95% CI
Completed Interview	7
Completed Interview	145

Maternal Wellbeing as Assessed Using the Parenting Stress Index Primary · 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

During the study-specific structured interview, maternal stress was measured using the Parenting Stress Index-Short Form (PSI-SF), which includes three subscales-Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, each containing 12 items. Mothers rated each of the 36 items on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Subscales are summed to compute a total score. The possible range is 36-180. Higher raw scores generally indicate higher levels of stress.

Group	Value	95% CI
Completed Interview	53.56	± 19.59

Maternal Social Support as Assessed Using The Social Provisions Scale Primary · 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

Maternal social support was assessed using The Social Provisions Scale during study-specific structured interview. Mothers were asked to think about their current relationships and rate 24 statements on a scale of 1 (strongly disagree) to 4 (strongly agree). The possible total range is 12-48, with higher scores indicating higher levels of social support.

Group	Value	95% CI
Completed Interview	44.26	± 5.07

Maternal Wellbeing as Assessed Using the Edinburgh Postpartum Depression Scale Primary · 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

maternal wellbeing as assessed using Edinburgh Postpartum Depression Scale (EPDS) during study-specific structured interview The possible range for the EPDS is 0-30, with higher scores indicating more depressive symptoms. Scores greater than or equal to 13 indicate possible clinical depression.

Group	Value	95% CI
Completed Interview	4.72	± 3.93

Maternal Wellbeing as Assessed Using the Generalized Anxiety Disorder (GAD-7) Primary · 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

During the study-specific structured interview, maternal well-being was measured using the Generalized Anxiety Disorder (GAD-7). Mothers were asked seven questions about how often they have been bothered by various problems, on a scale from 0 (not at all) to 3 (nearly every day). If they checked off any problems, they were additionally asked how difficult the problems have made it for them to do work, take care of things, or get along with others, on a scale from 0 (not difficult at all) to 3 (nearly every day).The possible range is a total score of 0-24, with higher scores indicating greater

Group	Value	95% CI
Completed Interview	4.01	± 3.53

Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status Primary · 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

maternal wellbeing as assessed using study-specific structured interview, i.e.: Are you or your partner using any form of contraception or birth control at this time? Since you came home from the hospital after birth, have you had to go to your doctor or a health clinic, to the emergency room or emergency department, or stayed overnight in the hospital for illness/injury/emergency? Did you complete your 6-week post-partum check-up? Do you currently have any kind of chronic health conditions? If yes, are you under the regular care of a doctor to help manage this condition? What type of health c

Dr. or clinic visit(s) for mother illness, injury, or emergency

Group	Value	95% CI
Maternal Wellbeing	51
Maternal Wellbeing	101
Maternal Wellbeing	0

Completed maternal 6-week post-partum check-up

Group	Value	95% CI
Maternal Wellbeing	142
Maternal Wellbeing	10
Maternal Wellbeing	0

Chronic health conditions such as high blood pressure or diabetes

Group	Value	95% CI
Maternal Wellbeing	21
Maternal Wellbeing	130
Maternal Wellbeing	0

Sees a health care provider regularly

Group	Value	95% CI
Maternal Wellbeing	125
Maternal Wellbeing	27
Maternal Wellbeing	0

Use of contraception or birth control at this time

Group	Value	95% CI
Maternal Wellbeing	100
Maternal Wellbeing	44
Maternal Wellbeing	6

Mother ER visits

Group	Value	95% CI
Maternal Wellbeing	24
Maternal Wellbeing	128
Maternal Wellbeing	0

Hospital overnight for mother illness, injury, or emergency

Group	Value	95% CI
Maternal Wellbeing	8
Maternal Wellbeing	144
Maternal Wellbeing	0

If sick and wanted to be seen by a doctor, mother would go to...PCP

Group	Value	95% CI
Maternal Wellbeing	109
Maternal Wellbeing	43
Maternal Wellbeing	0

Study-specific Structured Maternal Report Interview on Father's Supportive Parenting Primary · 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

maternal report of father's supportive parenting during study-specific structured interview, i.e.: How frequently does the father/partner (with/to the baby): Play games? Sing songs or nursery rhymes? Read stories? Tell stories? Play inside with toys? Take the baby to visit relatives? Helps the baby get dressed? Feeds the baby? Hug or show physical affection to the baby? Put the baby to bed? How often does he look after the baby? How often does he run errands for you? How often does he fix things around your home, paint, or help make it look nicer in other ways? How often does he take the baby

Group	Value	95% CI
Completed Interview	20.94	± 9.21

Parenting Indicators (Discipline) Primary · 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

4 items to measure parental use of discipline (yes/no), type of physical punishment used (spank/tap)

Use of physical discipline

Group	Value	95% CI
Completed Interview	2
Completed Interview	148

If yes, type of physical punishment used: spank/pop or slap

Group	Value	95% CI
Completed Interview	1
Completed Interview	1

If yes, type of physical punishment used: Tap

Group	Value	95% CI
Completed Interview	1
Completed Interview	1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.