(YMP) Young Moms Program
- Conditions
- Chronic Toxic StressDevelopmental/ Behavioral Regression in Young Children
- Registration Number
- NCT05082857
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15
- 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
- Newborn of participating mothers must be >= 35 weeks of gestation and not have an extended neonatal intensive care unit (NICU) stay
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Protective Factors Survey Score Month 6 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
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3) Score Month 2 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
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3) Month 6 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
Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score Month 6 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
The Patient Health Questionnaire (PHQ 9) Score Month 6 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.The StimQ2-I Infant Cognitive Home Environment Questionnaire Score No Availability of Learning (ALM) Month 6 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.
Full STIMQ2-I Including Availability of Learning Materials (ALM) Month 6 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.
- Secondary Outcome Measures
Name Time Method Percent of Mothers Currently Using Contraception Month 6 Percent of participants regularly using effective contraception
Percent of Mothers Breastfeeding Week 6, Month 3 and Month 6 Percent of mothers breastfeeding
Number of Completed Well Child Visits Week 1, Months 2, 4, and 6 The team will track completion of well-child visits
Number of Completed Immunizations Months 2, 4, and 6 The team will track completion of immunizations
Number of Emergency Department (ED) Visits Per Subject Month 6 The team will use WFBMC Epic data to track use of preventive rather than emergent health care
Percent of Mothers That Continue Current Educational Pathway Month 6 The study team will track whether or not participants continue their education during the study period
Number of Referrals Placed Per Subject Month 6 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.
Percent of Referrals Completed Month 6 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.
Percent of Completed Referrals That Result in Services Month 6 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.
Trial Locations
- Locations (1)
Wake Forest University Health Science
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University Health Science🇺🇸Winston-Salem, North Carolina, United States