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/8820075/Actively Recruiting
Led by University of Texas Southwestern Medical Center · Updated on 2026-07-09
100
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to evaluate if cognitive behavioral therapy CBT sessions can improve outcomes for parents and their premature infants who have spent time in the neonatal intensive care unit NICU. The study focuses on parents feelings of depression, anxiety, and post-traumatic stress disorder PTSD, which can affect how they perceive and care for their infants, potentially leading to Vulnerable Child Syndrome VCS or Parent Perceived Child Vulnerability PPCV. This trial investigates whether CBT can help parents better understand their childs health and boost their confidence in parenting, ultimately improving long-term outcomes for both. Participants will be randomly assigned to one of two groups a control group receiving standard NICU care and follow-up information, and an intervention group receiving the same standard care plus five CBT sessions. These sessions are split between the NICU and outpatient clinic visits after discharge, with three sessions before discharge and two after. The CBT sessions, designed to address PPCV, VCS, and parenting skills, will be delivered either in person or virtually using a standardized manual developed with expert input. During the study, parents will complete assessments using scales such as the Vulnerable Baby Scale at enrollment and after completing CBT sessions to measure changes in perceptions and mental health. Researchers will also track infant outcomes like length of stay in the NICU, medical visits post-discharge, and developmental milestones with the Capute Scales at six months. The study will continue follow-up until the infants reach six to nine months of post-birth age, monitoring the lasting effects of CBT on parents and children.
CONDITIONS
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
M
Margaret K Hoge, MD
R
Roy Heyne, MD
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
University of Texas Southwestern Medical Center
Lead Sponsor
Stanford University
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | CBT Program plus Standard NICU Information | Standard NICU Information Only |
|---|---|---|
| What it is | A structured program of five cognitive behavioral therapy sessions for NICU parents, split between inpatient (NICU) and outpatient (follow-up clinic) settings, focused on addressing parental perceptions of vulnerability and enhancing parenting skills, in addition to standard informational care. | Usual NICU and follow-up informational care for parents of premature infants, including standard guidance, education, and resources as routinely provided by the NICU and outpatient clinics. |
| Role in the trial | Assesses whether structured CBT, added to usual care, reduces parental perceptions of child vulnerability and improves related parent or child mental health outcomes. | Acts as the control, reflecting typical care and education provided, to measure whether the structured CBT program offers additional benefit. |
| Primary use | Designed to decrease parental perceptions of child vulnerability (PPCV) and the risk of developing vulnerable child syndrome, supporting parent mental health and healthy parent-child interactions. | Provides baseline parental guidance and NICU-related education, aiming to maintain current standard levels of parental adjustment and information without targeted behavioral intervention. |
| How it is given or performed | Delivered as a series of 5 standardized CBT sessions: 3 sessions while the parent is in the NICU and 2 sessions in the outpatient follow-up clinic after NICU discharge. Sessions follow a manual developed to address anxiety, depression, and NICU-specific parental concerns. | Standard educational and supportive resources are given during the NICU stay and in follow-up, as routinely offered by clinical staff. |
| Evidence status | Efficacy and outcome results on the use of CBT to reduce parental perceptions of child vulnerability among NICU parents are still under clinical investigation; results from this trial are not yet published for this specific intervention format. | There is limited published evidence for reducing PPCV with standard NICU parent information alone; standard information/support remains current practice but does not specifically target PPCV risk. |
| Important limitations | The structured CBT program requires trained staff and parent participation across both NICU and outpatient settings. Long-term outcomes and generalizability to other NICU settings remain unestablished until further studies are available. | Usual NICU information and standard care have not been proven to reduce PPCV or vulnerable child syndrome and may not address specific anxiety and mental health concerns in parents of premature infants. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 to 9 months post-birth
Participants receive either standard NICU care and follow-up information or standard care plus five cognitive behavioral therapy (CBT) sessions focusing on coping with NICU trauma and parenting skills. Three CBT sessions occur before NICU discharge and two after discharge, delivered in person or virtually.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Have more questions? Get in touch with our team for quick support
B W Forsyth, S M Horwitz, J M Leventhal...
https://pubmed.ncbi.nlm.nih.gov/8820075/Nicola J Kerruish, Kerryn Settle, Priscilla Campbell-Stokes...
https://pubmed.ncbi.nlm.nih.gov/16101975/Margaret K Hoge, Elizabeth Heyne, Steven Brown...
https://pubmed.ncbi.nlm.nih.gov/40374965/University of Texas Southwestern Medical Center
Lead Sponsor
Stanford University
Collaborating Sponsor