Parental Perception of Child Vulnerability in the NICU and Development Outcomes: A Randomized Control Trial Preventative Intervention With Cognitive Behavioral Therapy
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:
• Born at Parkland Hospital
• English or Spanish speaking mother +/- father
• ≤ 30.6 weeks gestation at birth
• Survival to 33 weeks gestation
Locations
United States
Texas
Parkland Health & Hospital System
RECRUITING
Dallas
Contact Information
Primary
Margaret K Hoge, MD
margaret.hoge@utsouthwestern.edu
214-617-8439
Backup
Roy Heyne, MD
roy.heyne@utsouthwestern.edu
Time Frame
Start Date: 2019-04-15
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Stanford University
Leads: University of Texas Southwestern Medical Center