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

NCT ID: NCT03906435

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2026-12-01

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.

Detailed Description

The NICU is a stressful experience for parents. This stress naturally affects parents in different ways, ranging from feelings of depression, anxiety, or post traumatic stress disorder (PTSD). While these feelings are very common in parents of NICU children, they can also impact the ways parents perceive their infants, which leads to alterations of parenting styles and exposure to developmental activities for growing infants. This phenomenon is well described in the literature as Vulnerable Child Syndrome (VCS), or Parent Perceived Child Vulnerability (PPCV) to illness. Traumatic events from earlier experiences in the NICU usually cause PPCV to occur. Examples of traumatic events include feared death of the child, which lead to parent anxiety, depression, or emotional trauma. This altered perception of the child has been linked to worsened development outcomes for NICU children further out into childhood and also continued feelings of depression, anxiety, or fear in the parents and lack of confidence in their parenting abilities.

CBT sessions have been proven beneficial for NICU parents by decreasing feelings of depression, anxiety, and PTSD. However, there has not been research to see if CBT sessions are impactful for PPCV and the impacts it has on parent and child outcomes. Since literature suggests that depression, anxiety, and PTSD play an integral role in the development of PPCV and VCS, it could be assumed that CBT sessions should also be beneficial for PPCV and VCS. Therefore, this study will research if CBT sessions can improve parent-child interactions before and after discharge by helping parents to better understand their child's health and empower them with confidence in parenting skills. It will also evaluate if the effects of the CBT sessions will remain present and beneficial for parents' perceptions over time. With the results of this study, it will be evaluated if it is possible to improve the care for parents and children in the NICU as well as the long-term outcomes of parents and NICU children through CBT.

This will be a randomized control trial and will be conducted to assess the outcomes of infants and parents receiving either CBT sessions versus standard of care.

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. Families will be approached at 33 weeks GA to participate in the study. Once enrolled, the mother (and father, if willing to participate) 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 delivered either in person or virtually). The CBT sessions will address PPCV and VCS in parents and parenting skills to address preventing 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. The investigators will look into the effects of in-person versus telehealth administration.

Scales used for assessment will be distributed at enrollment to the study and upon completion of the CBT sessions.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention CBT Arm

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Margaret Hoge

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret K Hoge, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center Dallas

Roy Heyne, MD

Role: STUDY_DIRECTOR

UT Southwestern Medical Center Dallas

Richard J Shaw, MD

Role: STUDY_DIRECTOR

Stanford University

Locations

Parkland Health & Hospital System

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Margaret K Hoge, MD

Role: CONTACT

margaret.hoge@utsouthwestern.edu

214-617-8439

Roy Heyne, MD

Role: CONTACT

roy.heyne@utsouthwestern.edu

Facility Contacts

Margaret K Hoge, MD

Role: primary

margaret.hoge@utsouthwestern.edu

405-596-2075

Roy Heyne, MD

Role: backup

roy.heyne@utsouthwestern.edu

References

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.

Reference Type: BACKGROUND

PMID: 16101975 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8820075 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40374965 (View on PubMed)

Other Identifiers

STU 072018-095

Identifier Type: -

Identifier Source: org_study_id