Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
This study, called the PreVNT Trial, is looking at whether Cognitive Behavioral Therapy (CBT) sessions can help parents of premature infants who have spent time in the Neonatal Intensive Care Unit (NICU). The goal is to improve outcomes for both the parents and their babies. Parents in the study will receive standard NICU care information plus five CBT sessions, split between the NICU and follow-up clinic visits after their baby goes home. These sessions aim to address "Parent Perceived Child Vulnerability" (PPCV), which is when parents feel their child is especially fragile due to their NICU experience. Researchers will measure the impact by looking at parents' scores on the Vulnerable Baby Scale (VBSc) at the start of the study and again 6 to 9 months after their baby's birth. To join, your baby must have been born at Parkland Hospital, be 30.6 weeks gestation or less at birth, and survive to 33 weeks gestation. You must also speak English or Spanish. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 100 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants in the intervention group will receive 5 Cognitive Behavioral Therapy (CBT) sessions, split between the NICU and outpatient clinic visits after discharge.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 to 9 months after their baby's birth to measure the primary endpoint.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
At a glance
Conditions
NCT03906435
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Parkland Health & Hospital System
Dallas, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- 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
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- mean value score Vulnerable Baby Scale (VBSc) Scoredifference 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
Measures parental perceptions of child vulnerability. It has been used for parents with infants as young as 10-12 weeks of age up through 6 months to a year old. It is a 10 question scale, with each question scored on a five point likert scale (1-5). Score range is 10-50. Maximum score of 50 possible. A score of 27 or more was the median score for a sample of medically fragile neonates, and signifies relatively high perceptions of vulnerability. While a score of 23 was the median for a sample of healthy controls and thus reflect a more normal perception of vulnerability (Kerruish et al 2005). The higher the score, the higher the perception of child vulnerability.