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Search / Trial NCT03906435

Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Apr 4, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Vulnerable Child Syndrome Neonatal Intensive Care Unit Cognitive Behavioral Therapy Parental Perception Of Child Vulnerability Child Developmental Outcomes Parent Mental Health

ClinConnect Summary

The PreVNT Trial is a study designed to help improve the well-being of parents and their premature infants who have spent time in the neonatal intensive care unit (NICU). Researchers are investigating whether parent cognitive behavioral therapy (CBT) sessions can positively impact both the mental health of parents and the development of their babies. The goal is to prevent issues like anxiety and depression in parents and promote better relationships between parents and their children.

To be eligible for this trial, mothers (and possibly fathers) must have given birth at Parkland Hospital, speak either English or Spanish, and have had their baby born at or before 30.6 weeks of pregnancy, with the baby surviving until at least 33 weeks. Participants can expect to receive therapy sessions aimed at improving their mental health during this challenging time. It's important to know that families with significant congenital health issues in the baby or those involved with child protective services cannot participate. This trial is currently recruiting participants, and anyone interested should consider discussing it with their healthcare provider.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Born at Parkland Hospital
  • English or Spanish speaking mother +/- father
  • ≤ 30.6 weeks gestation at birth
  • Survival to 33 weeks gestation
  • Exclusion Criteria:
  • Significant congenital anomalies
  • Child Protective Services (CPS) involvement or foster care placement -- Prior enrollment in this PreVNT study for an older sibling.

About University Of Texas Southwestern Medical Center

The University of Texas Southwestern Medical Center is a leading academic medical institution dedicated to advancing healthcare through innovative research, education, and clinical excellence. With a strong emphasis on translational medicine, the center conducts cutting-edge clinical trials aimed at developing novel therapies and improving patient outcomes across a wide range of diseases. Its multidisciplinary approach leverages a collaborative network of renowned faculty, state-of-the-art facilities, and a commitment to ethical research practices, positioning UT Southwestern at the forefront of medical discovery and patient care.

Locations

Dallas, Texas, United States

Dallas, Texas, United States

Patients applied

0 patients applied

Trial Officials

Margaret K Hoge, MD

Principal Investigator

UT Southwestern Medical Center Dallas

Roy Heyne, MD

Study Director

UT Southwestern Medical Center Dallas

Richard J Shaw, MD

Study Director

Stanford University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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