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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Texas Southwestern Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cognitive Behavioral Therapy

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Control ArmNo intervention 0 interventions
Group B: Intervention CBT ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

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.

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
2

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.

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
3

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.

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
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.

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.

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.

Other outcomes

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