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Nurse Family Partnership for Pregnancies
N/A
Recruiting
Led By Mandy A Allison, MD, MSPH
Research Sponsored by University of Colorado, Denver
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 less than 28 weeks gestation, 36 weeks gestation, index child ages 6, 12, 18, 24 months
Awards & highlights
Study Summary
This trial tests the effectiveness of the Nurse Family Partnership (NFP) in mothers with previous live births to reduce maternal morbidity & improve pregnancy & child outcomes, & describe & evaluate the effects of NFP on prior-born siblings.
Who is the study for?
This trial is for pregnant women who are less than 28 weeks along, have had a previous live birth, and qualify for Medicaid. They must also meet one of these conditions: under 20 years old, no high school diploma, homeless, past low-weight or premature births, severe pregnancy complications before, got pregnant within 18 months after last pregnancy, use tobacco or marijuana currently or have a history of substance abuse.Check my eligibility
What is being tested?
The Nurse Family Partnership program is being tested to see if it helps reduce health problems in mothers with more than one child and improves the outcomes for their new baby as well as older siblings under six. The program involves home visits from nurses to provide support.See study design
What are the potential side effects?
Since this intervention involves nurse home visits rather than medication or medical procedures, there aren't typical side effects like you'd expect with drugs. However, participants may experience emotional impacts due to discussions about personal topics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ less than 28 weeks gestation, 36 weeks gestation, index child ages 6, 12, 18, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~less than 28 weeks gestation, 36 weeks gestation, index child ages 6, 12, 18, 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in maternal tobacco use by cotinine
Change in self reported maternal tobacco use
Index child language development measured by the Bayley IV language subscale
+2 moreSecondary outcome measures
Change in maternal perceived stress measured by Perceived Stress Scale (maternal report)
Change in quality of home environment measured by the CHAOS (Confusion, Hubbub and Order Scale) Scale
Change in quality of home environment measured by the HOME (Home Observation Measurement of the Environment) Inventory short form
+13 moreTrial Design
2Treatment groups
Active Control
Group I: Intervention (NFP)Active Control1 Intervention
In the standard NFP intervention, low-income pregnant women are recruited to voluntarily join the program through their 28th week of pregnancy. Enrolled women receive home visits from a nurse. The visits can occur in-person or via telehealth. In-person visits can occur in the client's home or in another community location agreed upon by the client and the nurse (such as a library or coffee shop). The typical schedule for visits is weekly during the first month after enrollment, every two weeks until the birth of the infant, weekly during the post-partum period, then every two to four weeks until child age two.
Group II: ControlActive Control1 Intervention
The control group will receive usual care for pregnant people, which may include home visiting services from another source other than NFP. Participants who are randomly selected to receive other services will be given information about other services for which they may qualify and information about how to access those services.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,148,646 Total Patients Enrolled
Nationwide Children's HospitalOTHER
341 Previous Clinical Trials
5,219,626 Total Patients Enrolled
University of RochesterOTHER
840 Previous Clinical Trials
533,370 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am younger than 16 years old.I can communicate and understand English well enough to agree to participate in a study.I am under 19, lack a high school diploma, have been homeless, had a low birth weight or premature baby before, had a severe pregnancy complication, am pregnant again within 18 months of my last pregnancy, use tobacco or marijuana, have a history of substance abuse, or identify as Black/African American.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention (NFP)
- Group 2: Control
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.
Are there any opportunities for patients to join this research endeavor?
"Per clinicaltrials.gov, this experiment is presently seeking participants to join in on the trial. The initial posting of this study was done on March 31st 2023 and had a most recent update made on May 23rd 2023."
Answered by AI
How many participants are currently involved in this clinical trial?
"Affirmative. Per the data found on clinicaltrials.gov, this experiment is actively accepting participants. It was initially posted on March 31st 2023 and updated most recently on May 23rd of that same year. 880 people need to be enrolled from 1 particular medical centre."
Answered by AI
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