Recruiting
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
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.
ClinicalTrials.gov IDNCT03906435
PhaseNA
Enrollment100
SponsorUniversity of Texas Southwestern Medical Center
AgeNo minimum reported
SexALL
Conditions studied
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Development, Child, Parent-Child Relations
About this study
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.
Interventions
- Behavioral: Cognitive 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.
Primary outcomes
- mean value score Vulnerable Baby Scale (VBSc) Score (difference in the mean value score of the VBSc scores of parents at baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age)
Eligibility information
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.
Study locations
- Parkland Health & Hospital System, Dallas, Texas 75235 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.