(YMP) Young Moms Program (YMP)

Pediatric Parenting Connections Young Moms Program

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.

Study Overview

• Status: Completed
• Conditions: Chronic Toxic Stress; Developmental/ Behavioral Regression in Young Children
• Intervention / Treatment: Behavioral: "traditional" Parents as Teachers (PAT); Behavioral: "hybrid" PAT model

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: "traditional" Parents as Teachers (PAT); A twice-a-month home visits from trained family educators. Home visits will continue for the remainder of the study period as will the other components of the Parents as Teachers model: regular Group Connections for peer interactions and support, age-appropriate health and developmental screenings, and referrals that reflect mother and infant needs to community agencies that include the Child Development Services Agency (which provides screening for Individuals with Disabilities in Education Act (IDEA) Part C services), family services, intensive mental health services, among others. The study team will collect baseline data during the first home visit and complete monthly questionnaires during each month the mother is enrolled. An outcome assessment and participation in a focus group will be administered the last month of the study.	Behavioral: "traditional" Parents as Teachers (PAT); A twice-a-month home visits from trained family educators. Home visits will continue for the remainder of the study period as will the other components of the Parents as Teachers model: regular Group Connections for peer interactions and support, age-appropriate health and developmental screenings, and referrals that reflect mother and infant needs to community agencies that include the Child Development Services Agency (which provides screening for Individuals with Disabilities in Education Act (IDEA) Part C services), family services, intensive mental health services, among others.
Experimental: "hybrid" PAT model; A six-week virtual evidence-based parenting class entitled What You Do Matters, which will be delivered in partnership with the Pediatric Advocacy Program at WFBMC which combines short parent-educator discussions followed by interactive activities and peer to peer networking. Young moms will participate in Group Connections for peer interactions and support. After completing the six-week course, teens will begin receiving once a month home visits, ongoing Group Connections, age-appropriate health and developmental screenings, and referrals that reflect mother and infant needs to other community agencies and resources, as listed above. The study team will collect baseline data prior to the beginning of the virtual What You Do Matters program and will complete monthly questionnaires during each month the mother is enrolled. An outcome assessment and participation in a focus group will be administered the last month of the study.	Behavioral: "hybrid" PAT model; A six-week virtual evidence-based parenting class entitled What You Do Matters, which will be delivered in partnership with the Pediatric Advocacy Program at WFBMC which combines short parent-educator discussions followed by interactive activities and peer to peer networking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Patient Health Questionnaire (PHQ 9) Score	The Patient Health Questionnaire (PHQ 9) is a self-administered questionnaire that is validated for use in assessing the severity of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.	Baseline
The Patient Health Questionnaire (PHQ 9) Score	The Patient Health Questionnaire (PHQ 9) is a self-administered questionnaire that is validated for use in assessing the severity of depression. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.	Month 6
Protective Factors Survey Score	The Protective Factors Survey (PFS) is a 20-item measure - The PFS is a validated parent survey designed that assesses protective factors in five areas: family functioning/resiliency, social emotional support, concrete support, nurturing and attachment, and knowledge of parenting/child development - Each subscale is rated 1-7; higher is better - range is 35-175	Week 1
Protective Factors Survey Score	The Protective Factors Survey (PFS) is a 20-item measure - The PFS is a validated parent survey designed that assesses protective factors in five areas: family functioning/resiliency, social emotional support, concrete support, nurturing and attachment, and knowledge of parenting/child development - Each subscale is rated 1-7; higher is better - range is 35-175	Week 6
Protective Factors Survey Score	The Protective Factors Survey (PFS) is a 20-item measure - The PFS is a validated parent survey designed that assesses protective factors in five areas: family functioning/resiliency, social emotional support, concrete support, nurturing and attachment, and knowledge of parenting/child development - Each subscale is rated 1-7; higher is better - range is 35-175	Month 6
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3) Score	The Ages and Stages Questionnaire (ASQ 3) is a validated developmental screening designed for use by and with parents. The ASQ 3 screens for developmental milestones in communication, gross motor, fine motor, problem solving, and personal-social skills - Range is 0-60 for all age levels, higher is better	Month 2
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)	The Ages and Stages Questionnaire (ASQ 3) is a validated developmental screening designed for use by and with parents. The ASQ 3 screens for developmental milestones in communication, gross motor, fine motor, problem solving, and personal-social skills - Range is 0-60 for all age levels, higher is better	Month 4
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)	The Ages and Stages Questionnaire (ASQ 3) is a validated developmental screening designed for use by and with parents. The ASQ 3 screens for developmental milestones in communication, gross motor, fine motor, problem solving, and personal-social skills - Range is 0-60 for all age levels, higher is better	Month 6
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score	The Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) is a validated screening of social and emotional behaviors - Range 0-240, Monitor with scores 25-34, score positive and refer with scores >=35	Month 2
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score	The Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) is a validated screening of social and emotional behaviors - Range 0-345, Monitor with scores 35-44 , score positive and refer with scores >=45	Month 6
The StimQ2-I Infant Cognitive Home Environment Questionnaire Score No Availability of Learning (ALM)	The StimQ2-I is a validated, interview-based assessment of home environments for use with infants ages five to 12 months. The StimQ2-I focuses on cognitive stimulation by the primary caregiver and contains several scales: Reading-Verbal, Parental Involvement in Developmental Advance, and Parental Verbal Responsivity - subscale range Read = 15, Parental Involvement in Developmental Advance (PIDA) = 5, Performance Validity Test (PVT) = 16 -Total STIMQ-I score range for the no ALM portion is 0-36; higher score is better.	Month 6
Full STIMQ2-I Including Availability of Learning Materials (ALM)	The StimQ2-I is a validated, interview-based assessment of home environments for use with infants ages five to 12 months. The StimQ2-I focuses on cognitive stimulation by the primary caregiver and contains several scales: Availability of Learning Materials, Reading-Verbal, Parental Involvement in Developmental Advance, and Parental Verbal Responsivity - subscale range Read = 15, Parental Involvement in Developmental Advance (PIDA) = 5, Performance Validity Test (PVT) = 16, Availability of Learning Materials (ALM) = 6 Total score range for the STIMQ2-I including ALM is 0-42--a higher score is better.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Mothers Currently Using Contraception	Percent of participants regularly using effective contraception	Month 6
Percent of Mothers Breastfeeding	Percent of mothers breastfeeding	Week 6, Month 3 and Month 6
Number of Completed Well Child Visits	The team will track completion of well-child visits	Week 1, Months 2, 4, and 6
Number of Completed Immunizations	The team will track completion of immunizations	Months 2, 4, and 6
Number of Emergency Department (ED) Visits Per Subject	The team will use WFBMC Epic data to track use of preventive rather than emergent health care	Month 6
Percent of Mothers That Continue Current Educational Pathway	The study team will track whether or not participants continue their education during the study period	Month 6
Number of Referrals Placed Per Subject	Program services include developmental screenings, which in turn can lead to diagnostic assessments and, when eligible, enrollment in services. The team will track those infants are receiving the recommended screenings in a timely manner. Then, in cases where there are concerns, the team will follow-up with the young mom to determine whether or not the parent completed a formal assessment and, if eligible, enrolled in services.	Month 6
Percent of Referrals Completed	Program services include developmental screenings, which in turn can lead to diagnostic assessments and, when eligible, enrollment in services. The team will track those infants are receiving the recommended screenings in a timely manner. Then, in cases where there are concerns, the team will follow-up with the young mom to determine whether or not the parent completed a formal assessment and, if eligible, enrolled in services.	Month 6
Percent of Completed Referrals That Result in Services	Program services include developmental screenings, which in turn can lead to diagnostic assessments and, when eligible, enrollment in services. The team will track those infants are receiving the recommended screenings in a timely manner. Then, in cases where there are concerns, the team will follow-up with the young mom to determine whether or not the parent completed a formal assessment and, if eligible, enrolled in services.	Month 6

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Anna Miller-Fitzwater, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): January 5, 2023
• Study Completion (Actual): January 5, 2023

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: child maltreatment; child health; food insecurity; young moms; teen births
• Other Study ID Numbers: IRB00076601; UL1TR001420 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No