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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03906435
Status
Recruiting
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Conditions

  • Development, Child
  • Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
  • Parent-Child Relations
  • Premature Infant

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 15, 2019
Status verified
Jun 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Parkland Health & Hospital SystemDallasTexas75235
Margaret K Hoge, MD
[email protected]
405-596-2075
Roy Heyne, MD
[email protected]

Find similar trials in Dallas, TX

By research site
Parkland Health & Hospital System· Dallas, TX

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