Clinical trial NCT03906435: Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
Official title: Parental Perception of Child Vulnerability in the NICU and Development Outcomes: A Randomized Control Trial Preventative Intervention With Cognitive Behavioral Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2019-04-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: mean value score Vulnerable Baby Scale (VBSc) Score
timeFrame: 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:
measure: differences over time in subsets of Vulnerable Baby Scale (VBSc) scores
timeFrame: 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
measure: Correlation between changes over time in Vulnerable Baby Scale (VBSc) vs. Vulnerable Child Scale (VCSc) scores
timeFrame: measurement differences of scores from baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age
measure: differences over time in parent depression scores measured with Beck Depression Inventory Scale- 2nd edition.
timeFrame: 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
measure: 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.
timeFrame: 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.
measure: 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
timeFrame: from discharge from Parkland NICU until completion of the study at 6-9 months age
measure: differences over time in parent anxiety scores measured with Beck Anxiety Inventory Scale
timeFrame: 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
measure: The Capute Scales: Cognitive Adaptive Test/Clinical Linguistic and Auditory Milestones Scale (CAT/CLAMS)
timeFrame: It will be administered at 6 months of age for all children enrolled in both study groups
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health & Hospital System
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center Dallas
name: Margaret K Hoge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern Medical Center Dallas
name: Roy Heyne, MD
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Richard J Shaw, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.