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Prenatal Navigation Program for Maternal and Infant Health
N/A
Recruiting
Led By Kenneth Dodge
Research Sponsored by Duke University
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 63 months
Awards & highlights
Study Summary
This trial will test whether the Navigation program can help improve outcomes for mothers and infants.
Who is the study for?
This trial is for families in Durham County who visit certain OB/GYN offices for their first prenatal visit or the Roxboro Road Pediatric Care Practice for their child's well visits at 12, 24, or 36 months. Participants must speak English or Spanish. Families planning to move soon or with a parent having cognitive impairments that affect consent are excluded.Check my eligibility
What is being tested?
The 'Navigation' program is being tested to see its effects on maternal and infant health. It involves several visits by mothers during prenatal stages and when the child is aged 12, 24, and 36 months to connect them with healthcare services and follow up after one month.See study design
What are the potential side effects?
Since this study focuses on a community support intervention rather than a medical treatment, traditional side effects like those seen with medications are not applicable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 63 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~63 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the impact of the Navigation program by reviewing child health and development.
Evaluate the impact of the Navigation program by reviewing child maltreatment.
Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Navigation Intervention Prenatal 2.0Experimental Treatment1 Intervention
This program recruits mothers in OB/GYN offices. Mothers are offered visits from a Navigator prenatally and postnatally (12-, 24-, and 36-months). During visits, the Navigator works with the mother to identify family needs, establishes connections between the family and community providers, and follows up one month later to confirm these referrals. Navigators assess and support family needs across 13 factors: caregiver health, infant health, healthcare plans, childcare plans, parent-child relationship, management of infant crying/behavior, household safety/material supports, family/community violence, history of parenting difficulties, parent well-being, substance use, parent emotional support, and other needs not related to first 12 factors. Navigation 2.0 is a revision of 1.0 in which adjustments to the protocol were made to improve guidance for Community Navigators and aid their assessments of family needs.
Group II: Navigation Intervention Prenatal 1.0 (arm closed and modified to 2.0 design. Data will not be used)Experimental Treatment1 Intervention
This program recruits mothers in OB/GYN (prenatal) offices, provides up to three Navigation visits (using prenatal navigation version 1.0), establishes connections between the family and primary health care or other community providers, and then follows up one month later to confirm these referrals. Navigators will assess and support family needs across multiple developmentally-appropriate domains at each age. Prenatally, the domains include support for (1) health and access to healthcare, (2) adjustments to pregnancy, (3) household and material needs, and (4) family safety. At 12, 24, and 36 months, the domains include support for (1) child basic needs, (2) parenting and child behavior, (3) child health and development, and (4) parent health and well-being.
Group III: Control InterventionExperimental Treatment1 Intervention
Brief educational information will be provided about pregnancy (provided prenatally) and child development at 12, 24, and 36 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control Intervention
2014
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,419,686 Total Patients Enrolled
Kenneth DodgePrincipal InvestigatorDuke University
Kenneth Dodge, PhDPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Navigation Intervention Prenatal 1.0 (arm closed and modified to 2.0 design. Data will not be used)
- Group 2: Control Intervention
- Group 3: Navigation Intervention Prenatal 2.0
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum number of participants accepted for this trial?
"Indeed, the information on clinicaltrials.gov reveals that this study is currently enrolling patients. The research was first listed on November 20th 2020 and most recently updated in February 10th 2022. There are 800 prospective participants being sought from 1 medical centre."
Answered by AI
Is this medical trial accepting new participants at present?
"Affirmative. Clinicaltrials.gov's data shows that this trial is actively recruiting participants, with the initial posting date on November 20th 2020 and most recent update being February 10th 2022. This research endeavour needs 800 patients from a single medical centre to be enrolled."
Answered by AI
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