NCT03024385

Brief Summary

This model will utilize tools from the IMPLICIT (Interventions to Minimize Preterm and Low Birth Weight Infant through Continuous Quality Improvement Techniques) Network (collaboration of academic family medicine providers). The project involves assessing maternal risk behaviors that significantly affect subsequent birth outcomes: specifically smoking cessation, maternal depression, family planning and preconception folic acid supplementation during well child (WCC) visits. There is evidence that screening mothers for depression can be done at WCC. Data from IMPLCIT network has demonstrated increased screening and referral rates as well as decreased rates of prematurity. This is the first collaborative effort between Pediatrics and Family Medicine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,625

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

7.8 years

First QC Date

January 13, 2017

Last Update Submit

April 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Can pediatric primary care provider screen mother for maternal health behaviors during routine well child visits using brief questionnaires?

    Pediatric primary care providers (and family medicine providers who care for young infants) will screen mothers for maternal behaviors (smoking status, depression, prenatal multivitamin use, family planning) during routine well child visits of infants aged 0-2 years of age. Mothers will be screened for depression using a validated screening tool (Patient Health Questionnaire or PHQ: the 2 item PHQ-2 will be an initial screen; mothers who have a positive PHQ-2 will be offered the 9-item questionnaire ie the PHQ-9); screening for family planning needs, prenatal multivitamin use and smoking status will be in the form of "yes/no" answers.

    2 years

Secondary Outcomes (1)

  • Can pediatric primary care providers make appropriate recommendations for mothers with at risk behaviors using brief questionnaires?

    2 years

Study Arms (1)

Mothers of healthy infants

Mothers of young infants presenting for well child visits between the ages of 0-2 years of age

Behavioral: Well Child Visits

Interventions

Mothers of young infants will be screened for maternal behaviors that affect the outcome of future pregnancies. These behaviors are related to the following: family planning; smoking status, prenatal vitamin use and maternal depression. Mothers with positive screens will be offered appropriate resources. This will all take place during the child's routine well-child visit.

Also known as: Screening questions
Mothers of healthy infants

Eligibility Criteria

Age13 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a continuous quality improvement project. It has two aims: can providers screen mothers for health behaviors and can they offer appropriate resources to mothers in need? Thus the study populations are as follows: 1. Pediatric primary care providers and Family Medicine providers at UMMC 2. Mothers of young infants/toddlers seen in primary care clinics at UMMC

You may qualify if:

  • Pediatric Primary Care Providers and Family Medicine Providers at UMMC
  • Mothers of young infants/toddlers who present with their children for well child visits to UMC primary clinics -

You may not qualify if:

  • Specialists at UMMC
  • Fathers, grandparents, legal guardians - this screening only applies to mothers of young infants and toddlers -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (9)

  • MacDorman MF, Mathews TJ. Behind international rankings of infant mortality: how the United States compares with Europe. NCHS Data Brief. 2009 Nov;(23):1-8.

    PMID: 19887034BACKGROUND
  • Santos IS, Matijasevich A, Silveira MF, Sclowitz IK, Barros AJ, Victora CG, Barros FC. Associated factors and consequences of late preterm births: results from the 2004 Pelotas birth cohort. Paediatr Perinat Epidemiol. 2008 Jul;22(4):350-9. doi: 10.1111/j.1365-3016.2008.00934.x.

    PMID: 18578748BACKGROUND
  • Goedhart G, Snijders AC, Hesselink AE, van Poppel MN, Bonsel GJ, Vrijkotte TG. Maternal depressive symptoms in relation to perinatal mortality and morbidity: results from a large multiethnic cohort study. Psychosom Med. 2010 Oct;72(8):769-76. doi: 10.1097/PSY.0b013e3181ee4a62. Epub 2010 Jul 28.

    PMID: 20668282BACKGROUND
  • Johnson K, Posner SF, Biermann J, Cordero JF, Atrash HK, Parker CS, Boulet S, Curtis MG; CDC/ATSDR Preconception Care Work Group; Select Panel on Preconception Care. Recommendations to improve preconception health and health care--United States. A report of the CDC/ATSDR Preconception Care Work Group and the Select Panel on Preconception Care. MMWR Recomm Rep. 2006 Apr 21;55(RR-6):1-23.

    PMID: 16617292BACKGROUND
  • Murin S, Rafii R, Bilello K. Smoking and smoking cessation in pregnancy. Clin Chest Med. 2011 Mar;32(1):75-91. doi: 10.1016/j.ccm.2010.11.004.

    PMID: 21277451BACKGROUND
  • Sheeder J, Kabir K, Stafford B. Screening for postpartum depression at well-child visits: is once enough during the first 6 months of life? Pediatrics. 2009 Jun;123(6):e982-8. doi: 10.1542/peds.2008-1160.

    PMID: 19482749BACKGROUND
  • Ratcliffe S, Gambler A, Gross M, Horst M, Raff T. Preventing Prematurity: One Woman at a Time. The Journal of Lancaster General Hospital. Fall 2012,(7):3;69-74

    BACKGROUND
  • 2015 Premature Birth Report Cards. march of Dimes. http//:www.marchofdimes.org/mission/prematurity-reportcard.aspx. Accessed 2/18/2016

    BACKGROUND
  • Maternal, Infant and Child Health. Healthy People 2020. https://www.healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health.Accessed 2/18/2016

    BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Sarah MH Jones, MD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 18, 2017

Study Start

March 20, 2017

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

April 27, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations