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"hybrid" PAT model for Chronic Toxic Stress (YMP Trial)

N/A

Waitlist Available

Led By Anna Miller-Fitzwater, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1, months 2, 4, and 6

Awards & highlights

YMP Trial Summary

This trial program is designed to help young mothers and their children by addressing systemic problems and making it easier to access resources and information.

Eligible Conditions

Chronic Toxic Stress
Developmental/Behavioral Regression

YMP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1, months 2, 4, and 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1, months 2, 4, and 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, months 2, 4, and 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Protective Factors Survey Score

The Ages and Stages Questionnaire (ASQ 3) Score

The Ages and Stages Questionnaire: Social-Emotional (ASQ:SE 2) Score

+2 more

Secondary outcome measures

Number of Emergency Department (ED) visits per Subject

Number of Referrals placed per Subject

Number of completed Immunizations

+6 more

YMP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: "hybrid" PAT modelExperimental Treatment1 Intervention

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.

Group II: "traditional" Parents as Teachers (PAT)Active Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

"hybrid" PAT model

2021

N/A

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,239 Previous Clinical Trials

1,004,168 Total Patients Enrolled

Anna Miller-Fitzwater, MDPrincipal InvestigatorWake Forest University Health Sciences

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this medical experiment that participants may occupy?

"The details posted on clinicaltrials.gov suggest that this medical trial is not actively seeking out patients at the current moment, even though it was first advertised on December 21st 2021 and last updated in July 27th 2022. Nonetheless, there are other experiments open to participants as of now."

Answered by AI

What are the key goals of this research endeavor?

"The primary endpoint of this study, due to be evaluated after a period of 6 months, is the Protective Factors Survey Score. Secondary endpoints include Number of completed Immunizations (tracking completion), Percent of Referrals Completed (monitoring timely screenings and follow-ups for parents with concerns) as well as Percent of Mothers Currently Using Contraception (measuring regular contraceptive use)."

Answered by AI

Does the trial encompass any geriatric participants?

"Eligibility for this medical trial lies between the ages of 14 and 21."

Answered by AI

What demographic is eligible to participate in this experiment?

"This medical trial is recruiting 15 participants aged between 14 and 21 who have experienced regression in their development/behavior. To qualify, individuals must be post-partum mothers living with their newborn infant and referred by either the Birth Center at Wake Forest Baptist Health or one of its Patient Priorities Care (PPC) partner practices."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

(YMP) Young Moms Program

2021. "(YMP) Young Moms Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05082857.