Clinical trial NCT05082857: (YMP) Young Moms Program
Official title: Pediatric Parenting Connections Young Moms Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Toxic Stress
Developmental/ Behavioral Regression in Young Children
Keywords: young moms
child health
teen births
child maltreatment
food insecurity
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-10-19
Enrollment: 15
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study team will employ a blind randomized design to assign individuals to either the "traditional" Parents as Teachers (PAT) or the "hybrid" PAT model.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Young Moms Program (YMP) is designed to address systemic barriers to the health and stability of young moms and their children such as the lack of coordination of service delivery or logistical barriers within the health system. The YMP also streamlines the referral pipeline, connecting moms to evidence-based resources, and ensuring children complete all recommended assessments prior to kindergarten.

Detailed description: This application is a community-engaged research collaboration between the non-profit Imprints Cares, the Wake Forest Baptist Medical Center (WFBMC) Birth Center, and Wake Forest School of Medicine (WFSOM). This project addresses the myriad risks associated with young moms ≤ 21 years old. Because YMP is a tiered program model, services meet parents where they are through a "warm hand-off" approach that uses one-on-one consultation and assessment-based interventions.

Eligibility criteria: Inclusion Criteria:

* Subject must be an immediately post-partum mother
* Subject will reside with her newborn
* Subject must be referred from either the Birth Center at Wake Forest Baptist Health or from one of the Wake Forest Baptist Health Patient Priorities Care (PPC) partner practices
* Participants must speak English or Spanish

Exclusion Criteria:

* Newborn of participating mothers must be \>= 35 weeks of gestation and not have an extended neonatal intensive care unit (NICU) stay

Primary outcomes:
measure: Protective Factors Survey Score
timeFrame: Week 1
measure: Protective Factors Survey Score
timeFrame: Week 6
measure: Protective Factors Survey Score
timeFrame: Month 6
measure: Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3) Score
timeFrame: Month 2
measure: Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)
timeFrame: Month 4
measure: Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)
timeFrame: Month 6
measure: Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score
timeFrame: Month 2
measure: Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score
timeFrame: Month 6
measure: The Patient Health Questionnaire (PHQ 9) Score
timeFrame: Baseline
measure: The Patient Health Questionnaire (PHQ 9) Score
timeFrame: Month 6
measure: The StimQ2-I Infant Cognitive Home Environment Questionnaire Score No Availability of Learning (ALM)
timeFrame: Month 6
measure: Full STIMQ2-I Including Availability of Learning Materials (ALM)
timeFrame: Month 6
Secondary outcomes:
measure: Percent of Mothers Currently Using Contraception
timeFrame: Month 6
measure: Percent of Mothers Breastfeeding
timeFrame: Week 6, Month 3 and Month 6
measure: Number of Completed Well Child Visits
timeFrame: Week 1, Months 2, 4, and 6
measure: Number of Completed Immunizations
timeFrame: Months 2, 4, and 6
measure: Number of Emergency Department (ED) Visits Per Subject
timeFrame: Month 6
measure: Percent of Mothers That Continue Current Educational Pathway
timeFrame: Month 6
measure: Number of Referrals Placed Per Subject
timeFrame: Month 6
measure: Percent of Referrals Completed
timeFrame: Month 6
measure: Percent of Completed Referrals That Result in Services
timeFrame: Month 6
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Science
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Anna Miller-Fitzwater, MD
role: PRINCIPAL_INVESTIGATOR
References: