Purpose

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

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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.
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
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.
Experimental
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.
  • Behavioral: 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.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of Texas Southwestern Medical Center

Study Contact

Margaret K Hoge, MD
214-617-8439
margaret.hoge@utsouthwestern.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.