About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Born at Parkland Hospital
English or Spanish speaking mother +/- father
≤ 30.6 weeks gestation at birth
Survival to 33 weeks gestation
Disqualifiers
Significant congenital anomalies
Child Protective Services (CPS) involvement or foster care placement -- Prior enrollment in this PreVNT study for an older sibling.
Trial design
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
differences over time in subsets of Vulnerable Baby Scale (VBSc) scores
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.
Correlation between changes over time in Vulnerable Baby Scale (VBSc) vs. Vulnerable Child Scale (VCSc) scores
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.
differences over time in parent depression scores measured with Beck Depression Inventory Scale- 2nd edition.
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.
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.
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.
Sponsors and contacts
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University of Texas Southwestern Medical Center
Lead sponsor
Stanford University
Collaborator