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Nurse Home Visiting for Child Development
N/A
Waitlist Available
Led By Lisa J Berlin, PhD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to five and a half years post-psychosocial interview
Awards & highlights
Study Summary
This trial is studying whether a nurse home visiting program can help improve early child development.
Who is the study for?
This trial is for mothers and infants living in Baltimore City, where the birth took place at Sinai Hospital starting around July 15, 2019. Participants must speak English. It's not open to those who don't meet these location, hospital birth timing, or language requirements.Check my eligibility
What is being tested?
The study tests if a nurse home visiting program can improve child development and family outcomes. This includes reducing infant ER visits/hospital stays, increasing use of community resources/quality childcare, improving maternal wellbeing, and enhancing home safety/supportive parenting.See study design
What are the potential side effects?
Since this trial involves community services rather than medical treatments or drugs, there are no typical side effects like you'd expect with medication. However, participation could impact family routines or privacy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to five and a half years post-psychosocial interview
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five and a half years post-psychosocial interview
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
data collection from records on family use of community resources
data collection from records on infant emergency room use
data collection from records on infant overnight hospital stays
+17 moreSecondary outcome measures
data collection from records of rates of official investigations for child maltreatment
maternal wellbeing as assessed using the Adult Attachment (AAS)
maternal wellbeing as assessed using the Adverse Childhood Experiences (ACEs)
+2 moreOther outcome measures
data collection from records of early educational achievement: kindergarten readiness scores, exploratory
data collection from records of early educational achievement: rates of kindergarten attendance, exploratory
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nurse Home Visiting GroupExperimental Treatment1 Intervention
This group will be offered services from the nurse home visiting program.
Group II: Non-intervention GroupActive Control1 Intervention
This group will not be offered services from the nurse home visiting program.
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Who is running the clinical trial?
LifeBridge HealthOTHER
28 Previous Clinical Trials
4,091 Total Patients Enrolled
University of Maryland, BaltimoreLead Sponsor
692 Previous Clinical Trials
376,587 Total Patients Enrolled
Lisa J Berlin, PhDPrincipal InvestigatorUniversity of Maryland, College Park
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My mother speaks English.My mother does not speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Nurse Home Visiting Group
- Group 2: Non-intervention Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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