Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)

NCT03906435 | Recruiting DMC

• 1 other identifier: STU 072018-095
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Infant; Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse); Development, Child; Parent-Child Relations

Keywords

Vulnerable Child Syndrome; Neonatal Intensive Care Unit; Cognitive Behavioral Therapy; Parental Perception of Child Vulnerability; Child Developmental Outcomes; Parent Mental Health

Outcome Measures

Primary Outcomes (1)

• mean value score Vulnerable Baby Scale (VBSc) Score

  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.

  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

Secondary Outcomes (7)

• differences over time in subsets of Vulnerable Baby Scale (VBSc) scores

  measurement differences over time between the total number of questions endorsed for each of the three different question subsets of VBSc of the parents at baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age

• Correlation between changes over time in Vulnerable Baby Scale (VBSc) vs. Vulnerable Child Scale (VCSc) scores

  measurement differences of scores from baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age

• differences over time in parent depression scores measured with Beck Depression Inventory Scale- 2nd edition.

  measure differences of the scale's total score between timepoints at baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age

• child length of stay in the Parkland NICU (number of days) from birth to discharge from NICU, not including readmissions once first discharge has been accomplished.

  Days will be counted that are spent in the NICU starting from the day of birth of the child which is the admission day to the NICU until discharge day that is documented from Parkland NICU, through study completion, an average of 1 year.

• Child medical system usage score: number of non-well child or follow up visits/encounters until the last follow-up visit at 6-9 months averaged over the amount of months

  from discharge from Parkland NICU until completion of the study at 6-9 months age

Study Arms (2)

Control Arm

NO INTERVENTION

Standard of care information given by NICU staff and Follow up Clinic staff, including information about health care, diagnosis, medications, daily cares, anticipatory guidance, and discharge prep information.

Intervention CBT Arm

EXPERIMENTAL

In addition to Standard of care information that the control arm receives, this arm will also receive 5 CBT sessions focusing on past NICU trauma, emotional coping, parental perceptions of child vulnerability, and helpful parenting and emotional coping skills.

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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.

Intervention CBT Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Born at Parkland Hospital
• English or Spanish speaking mother +/- father
• ≤ 30.6 weeks gestation at birth
• Survival to 33 weeks gestation

You may not qualify if:

• Significant congenital anomalies
• Child Protective Services (CPS) involvement or foster care placement -- Prior enrollment in this PreVNT study for an older sibling.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Stanford University: collaborator

Study Sites (1)

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

RECRUITING

Related Publications (3)

• Kerruish NJ, Settle K, Campbell-Stokes P, Taylor BJ. Vulnerable Baby Scale: development and piloting of a questionnaire to measure maternal perceptions of their baby's vulnerability. J Paediatr Child Health. 2005 Aug;41(8):419-23. doi: 10.1111/j.1440-1754.2005.00658.x.

  PMID: 16101975 BACKGROUND

• Forsyth BW, Horwitz SM, Leventhal JM, Burger J, Leaf PJ. The child vulnerability scale: an instrument to measure parental perceptions of child vulnerability. J Pediatr Psychol. 1996 Feb;21(1):89-101. doi: 10.1093/jpepsy/21.1.89.

  PMID: 8820075 BACKGROUND

• Hoge MK, Heyne E, Brown S, Heyne R, Shaw RJ, Chalak L. Reduction of neonatal intensive care unit (NICU) parental perceptions of child vulnerability and risk of vulnerable child syndrome utilizing cognitive behavioral therapy: randomized controlled trial. Pediatr Res. 2025 May 15. doi: 10.1038/s41390-025-04094-x. Online ahead of print.

  PMID: 40374965 DERIVED

MeSH Terms

Conditions

Premature Birth; Depression; Psychotic Disorders; Personality Disorders; Substance-Related Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Margaret K Hoge, MD

  UT Southwestern Medical Center Dallas

  PRINCIPAL INVESTIGATOR

• Roy Heyne, MD

  UT Southwestern Medical Center Dallas

  STUDY DIRECTOR

• Richard J Shaw, MD

  Stanford University

  STUDY DIRECTOR

Central Study Contacts

Margaret K Hoge, MD

CONTACT

214-617-8439; margaret.hoge@utsouthwestern.edu

Roy Heyne, MD

CONTACT

roy.heyne@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This will be a non-blinded randomized control to assess the outcomes of infants and parents receiving either Cognitive Behavioral Therapy (CBT) sessions focusing on NICU trauma, emotional responses, and parent perceptions of child vulnerability (PPCV) versus standard of care without CBT sessions. English and/or Spanish speaking parents of infants born at 30.6 weeks gestational age (GA) or less who survive to 33 weeks GA will be eligible to participate in the study. Once enrolled, the mother (and father, if willing) will be randomized into a control group (standard NICU and follow up care information) versus the intervention group (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 be standardized with a manual. Scales used for assessment will be distributed at enrollment to the study and upon completion of the CBT sessions.

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: April 8, 2019
• Study Start: April 15, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: upon start of study to completion of study and manuscript submission.

Locations

US (1)