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Completed

NCT Number: NCT05082857

(YMP) 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.

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Key information

Conditions

Chronic Toxic Stress Developmental/ Behavioral Regression in Young Children

Age range

14 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Science

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"traditional" Parents as Teachers (PAT)

Behavioral

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.

"hybrid" PAT model

Behavioral

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.

Primary outcomes

  1. Protective Factors Survey Score

    Time frame: Week 1

    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

  2. Protective Factors Survey Score

    Time frame: Week 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

  3. 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

  4. 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

  5. Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire (ASQ 3)

    Time frame: Month 4

    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

  6. 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

  7. Number of Children Screen Positive for Delays Using the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score

    Time frame: Month 2

    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

  8. 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

  9. The Patient Health Questionnaire (PHQ 9) Score

    Time frame: Baseline

    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.

  10. 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.

  11. 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.

  12. 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

  1. Percent of Mothers Currently Using Contraception

    Time frame: Month 6

    Percent of participants regularly using effective contraception

  2. Percent of Mothers Breastfeeding

    Time frame: Week 6, Month 3 and Month 6

    Percent of mothers breastfeeding

  3. Number of Completed Well Child Visits

    Time frame: Week 1, Months 2, 4, and 6

    The team will track completion of well-child visits

  4. Number of Completed Immunizations

    Time frame: Months 2, 4, and 6

    The team will track completion of immunizations

  5. Number of Emergency Department (ED) Visits Per Subject

    Time frame: Month 6

    The team will use WFBMC Epic data to track use of preventive rather than emergent health care

  6. Percent of Mothers That Continue Current Educational Pathway

    Time frame: Month 6

    The study team will track whether or not participants continue their education during the study period

  7. Number of Referrals Placed Per Subject

    Time frame: 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.

  8. Percent of Referrals Completed

    Time frame: 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.

  9. Percent of Completed Referrals That Result in Services

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Pediatric Parenting Connections Young Moms Program

Acronym: YMP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.