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

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ClinicalTrials.gov Identifier: NCT03906435
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Premature Infant Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) Development, Child Parent-Child Relations Behavioral: Cognitive Behavioral Therapy Not Applicable

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). 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.

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Parental Perception of Child Vulnerability in the NICU and Development Outcomes: A Randomized Control Trial Preventative Intervention With Cognitive Behavioral Therapy
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. mean value score Vulnerable Baby Scale (VBSc) Score [ Time Frame: 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 ]
    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.


Secondary Outcome Measures :
  1. differences over time in subsets of Vulnerable Baby Scale (VBSc) scores [ Time Frame: 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 ]
    The VBSc can be broken down into subsets of questions addressing parent 1) thoughts: 2 questions of 10 scale questions, scored 0-2; 2) feelings: 3 questions of 10 scale questions, scored 0-3; and 3) actions/behaviors: 5 questions out of 10 scale questions, scored 0-5. This quantifies the amounts of subsets of the scale that the parent endorses. Higher numbers are markers of more and worse perceptions of child vulnerability in each category of thought, feeling, and action/behavior.

  2. Correlation between changes over time in Vulnerable Baby Scale (VBSc) vs. Vulnerable Child Scale (VCSc) scores [ Time Frame: measurement differences of scores from baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age ]
    The VCSc is the most frequently and widely used scale to measure parent perceptions of vulnerability and Vulnerable Child Syndrome (VCS). It was modified by the author from the original 12 question scale to an 8 question scale. The modified scale has higher internal validity and consistency (Forsyth et al 1996). This scale was intended for and has been used for children aged mostly from 6 months to 8 years of age or older. Each question is scored on a four point likert scale (0-3). A total score of 0 to 24 is possible, the higher the score the more perceptions of vulnerability. A score of greater than 10 signifies high perceptions of vulnerability. See above for VBSc description.

  3. differences over time in parent depression scores measured with Beck Depression Inventory Scale- 2nd edition. [ Time Frame: 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 ]
    Beck Depression Inventory - 2nd Edition: This will be used to measure parent depression scores, which can be associated with development of VCS. This will be used as a secondary outcome in change over time throughout the study. This is a 21 item questionnaire, measured on a four point likert scale (0-3). A score of greater than 14 signifies depression, with higher scores representing more severe levels of depression. Scores of 0-13= No depression; 14-19= mild; 20-28= moderate; 29-63= severe.

  4. 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. [ Time Frame: 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 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. Scored in number of total days in the NICU (0 to infinite number). The higher the number, the more lengthy the NICU stay.

  5. 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 [ Time Frame: from discharge from Parkland NICU until completion of the study at 6-9 months age ]
    The electronic medical record will be evaluated for how many total sick visits or hospital admissions are documented each month post discharge at Children's Medical Center and any associated hospitals that share medical records on the electronic medical record. The total number of encounters will be averaged over the amount of months from NICU discharge until the end of the study. Routine health checks will not be included in this number. A higher number will signify higher health care system usage.

  6. differences over time in parent anxiety scores measured with Beck Anxiety Inventory Scale [ Time Frame: 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 ]
    Beck Anxiety Inventory: This will be used to measure parent anxiety scores, which can be associated with development of VCS. This will be used as a secondary outcome for change over time throughout the study. This is a 21 item questionnaire, measured on a four point likert scale (0-3). Possible scores range from 0-36. A score of greater than 7 suggests anxiety. Scores of 8-15= mild; 16-25= moderate; 26-36= severe.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906435


Contacts
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Contact: Margaret K Hoge, MD 214-617-8439 margaret.hoge@utsouthwestern.edu
Contact: Roy Heyne, MD roy.heyne@utsouthwestern.edu

Locations
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United States, Texas
Parkland Health & Hospital System Recruiting
Dallas, Texas, United States, 75235
Contact: Margaret K Hoge, MD    405-596-2075    margaret.hoge@utsouthwestern.edu   
Contact: Roy Heyne, MD       roy.heyne@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Stanford University
Investigators
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Principal Investigator: Margaret K Hoge, MD UT Southwestern Medical Center Dallas
Study Director: Roy Heyne, MD UT Southwestern Medical Center Dallas
Study Director: Richard J Shaw, MD Stanford University

Publications of Results:
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03906435     History of Changes
Other Study ID Numbers: STU072018-095
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There will be a data sharing agreement signed between all parties and institutions to agree to share data safely and confidentially. The data shared will be de-identified for the purposes of data analysis and result interpretation.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: upon start of study to completion of study and manuscript submission.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Texas Southwestern Medical Center:
Vulnerable Child Syndrome
Neonatal Intensive Care Unit
Cognitive Behavioral Therapy
Parental Perception of Child Vulnerability
Child Developmental Outcomes
Parent Mental Health

Additional relevant MeSH terms:
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Substance-Related Disorders
Personality Disorders
Chemically-Induced Disorders
Mental Disorders