Pediatric Parenting Connections Young Moms Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Protective Factors Survey Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 14 Years to 21 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Protective Factors Survey Score
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Percent of Mothers Currently Using Contraception(Month 6)
- Percent of Mothers Breastfeeding(Week 6, Month 3 and Month 6)
- Number of Completed Well Child Visits(Week 1, Months 2, 4, and 6)
- Number of Completed Immunizations(Months 2, 4, and 6)
- Number of Emergency Department (ED) Visits Per Subject(Month 6)
- Percent of Mothers That Continue Current Educational Pathway(Month 6)
- Number of Referrals Placed Per Subject(Month 6)
- Percent of Referrals Completed(Month 6)
- Percent of Completed Referrals That Result in Services(Month 6)