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

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a talk therapy program (cognitive behavioral therapy) for parents of very premature babies can prevent overly anxious parenting patterns — sometimes called vulnerable child syndrome — which can affect a child's long-term development. **You may be eligible if...** - Your baby was born at Parkland Hospital at 30 weeks and 6 days of pregnancy or earlier - Your baby survived to 33 weeks gestational age - You are an English or Spanish-speaking mother (fathers may also participate) **You may NOT be eligible if...** - Your baby has significant birth defects - Child Protective Services is involved or the baby is in foster care - You have previously enrolled an older sibling in this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT03906435


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