RecruitingNot ApplicableNCT03906435

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

Parental Perception of Child Vulnerability in the NICU and Development Outcomes: A Randomized Control Trial Preventative Intervention With Cognitive Behavioral Therapy


Sponsor

University of Texas Southwestern Medical Center

Enrollment

100 participants

Start Date

Apr 15, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral therapy (CBT) sessions.


Eligibility

Inclusion Criteria4

  • Born at Parkland Hospital
  • English or Spanish speaking mother +/- father
  • ≤ 30.6 weeks gestation at birth
  • Survival to 33 weeks gestation

Exclusion Criteria2

  • Significant congenital anomalies
  • Child Protective Services (CPS) involvement or foster care placement -- Prior enrollment in this PreVNT study for an older sibling.

Interventions

BEHAVIORALCognitive Behavioral Therapy

The intervention group will receive standard NICU and follow up care information plus a total of 5 CBT sessions split between the NICU and outpatient clinic visits post discharge from NICU. The CBT sessions will address PPCV in parents and parenting skills to address this. The CBT sessions will be standardized with a manual for study investigators to follow during sessions, and made with Dr. Richard Shaw from Stanford University, who wrote the prior CBT manual for anxiety, depression, and PTSD for NICU parents. Study staff will be trained to give the standardized CBT sessions using the manual via pilot sessions. There will be 3 CBT sessions given in the Parkland NICU before discharge and then 2 in the THRIVE follow up clinic at Children's Medical Center after discharge from the NICU.


Locations(1)

Parkland Health & Hospital System

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03906435


Related Trials