Vulnerable Baby Scale: development and piloting of a questionnaire to measure maternal perceptions of their baby's vulnerability.
Nicola J Kerruish, Kerryn Settle, Priscilla Campbell-Stokes...
https://pubmed.ncbi.nlm.nih.gov/16101975Actively Recruiting
Phase Not Applicable
All Genders
Healthy Volunteers
ID03906435
Parental Perception of Child Vulnerability in the NICU and Development Outcomes: A Randomized Control Trial Preventative Intervention With Cognitive Behavioral Therapy
Led by University of Texas Southwestern Medical Center · Updated on 2025-06-13
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
S
Stanford University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether cognitive behavioral therapy (CBT) sessions can improve outcomes for premature infants born at 30.6 weeks gestation or less and their parents who have spent time in the neonatal intensive care unit (NICU). This study focuses on reducing parental stress, anxiety, depression, and post-traumatic stress disorder (PTSD) that can affect parenting styles and infant development, a phenomenon known as Vulnerable Child Syndrome (VCS) or Parent Perceived Child Vulnerability (PPCV). Participants will be randomly assigned to either a control group receiving standard NICU and follow-up care information or an intervention group receiving the same standard care plus five CBT sessions. Three CBT sessions are given before NICU discharge and two sessions after discharge during outpatient clinic visits, delivered either in person or via telehealth. These sessions aim to address past NICU trauma, emotional coping, and parental perceptions of child vulnerability, following a standardized manual. Throughout the study, parents will complete assessment scales at enrollment and after completing CBT sessions to measure changes in perceptions and mental health. Researchers will track infant length of NICU stay, medical system usage, and developmental milestones using tools like the Vulnerable Baby Scale and Capute Scales. The study includes follow-up assessments up to six to nine months post-birth to evaluate long-term effects on both parents and infants.
CONDITIONS
Brief Title
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
Who Can Participate
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Born at Parkland Hospital
- English or Spanish speaking mother with or without father
- Born at 30.6 weeks gestation or earlier
- Infant survived to 33 weeks gestation
You will not qualify if you...
- Significant congenital anomalies
- Child Protective Services involvement or foster care placement
- Prior enrollment in this PreVNT study for an older sibling
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From 33 weeks gestational age until after NICU discharge and follow-up visits
Participants in the intervention group receive 5 Cognitive Behavioral Therapy (CBT) sessions focused on parental perceptions of child vulnerability and parenting skills. Three sessions occur in the NICU before discharge and two sessions take place at the outpatient follow-up clinic after discharge. Participants in the control group receive standard NICU and follow-up care information only.
3 visits in the NICU and 2 outpatient clinic visits
Follow-up
Duration - Up to 6 to 9 months post-birth
Participants are assessed for parent and child outcomes including parental perceptions, depression, anxiety, and child development up to six to nine months post-birth.
Assessments at baseline and at 6 to 9 months
Trial Site Locations
Total: 1 location
1
Parkland Health & Hospital System
Dallas, Texas, United States, 75235
Actively Recruiting
Loading map...
Research Team
M
Margaret K Hoge, MD
R
Roy Heyne, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
The child vulnerability scale: an instrument to measure parental perceptions of child vulnerability.
B W Forsyth, S M Horwitz, J M Leventhal...
https://pubmed.ncbi.nlm.nih.gov/8820075Reduction of neonatal intensive care unit (NICU) parental perceptions of child vulnerability and risk of vulnerable child syndrome utilizing cognitive behavioral therapy: randomized controlled trial.
Margaret K Hoge, Elizabeth Heyne, Steven Brown...
https://pubmed.ncbi.nlm.nih.gov/40374965