N/A N=15 Randomized Double-blind Supportive Care

(YMP) Young Moms Program

Chronic Toxic Stress · Developmental/ Behavioral Regression in Young Children

Bottom Line

View on ClinicalTrials.gov: NCT05082857 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Protective Factors Survey Score — 104.7; 98 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: "traditional" Parents as Teachers (PAT) (Behavioral); "hybrid" PAT model (Behavioral)
Age: Pediatric, Adult · 14+ yrs
Sex: Female
Sponsor: Wake Forest University Health Sciences
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Protective Factors Survey Score	108; 104.7	—
PRIMARY Protective Factors Survey Score	108; 104.7	—
PRIMARY Protective Factors Survey Score	108; 104.7	—
PRIMARY Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3) Score	1; 0	—
PRIMARY Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)	0; 0	—
PRIMARY Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)	0; 0	—
PRIMARY Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score	0; 0	—
PRIMARY Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score	0; 0	—
PRIMARY The Patient Health Questionnaire (PHQ 9) Score	4.6; 3.3	—
PRIMARY The Patient Health Questionnaire (PHQ 9) Score	4.6; 3.3	—
PRIMARY The StimQ2-I Infant Cognitive Home Environment Questionnaire Score No Availability of Learning (ALM)	29.4; 20.3	—
PRIMARY Full STIMQ2-I Including Availability of Learning Materials (ALM)	40.4; 28	—
SECONDARY Percent of Mothers Currently Using Contraception	60; 67	—
SECONDARY Percent of Mothers Breastfeeding	80; 50; 60; 0	—
SECONDARY Number of Completed Well Child Visits	—	—
SECONDARY Number of Completed Immunizations	—	—
SECONDARY Number of Emergency Department (ED) Visits Per Subject	—	—
SECONDARY Percent of Mothers That Continue Current Educational Pathway	20; 33	—
SECONDARY Number of Referrals Placed Per Subject	—	—
SECONDARY Percent of Referrals Completed	—	—
SECONDARY Percent of Completed Referrals That Result in Services	—	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05082857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.