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Behavioral Intervention
Cognitive Behavioral Therapy for Premature Infants' Families (PreVNT Trial)
N/A
Recruiting
Led By Margaret K Hoge, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from discharge from parkland nicu until completion of the study at 6-9 months age
Awards & highlights
PreVNT Trial Summary
This trial is testing if CBT can help improve outcomes for both premature babies and their parents.
Who is the study for?
This trial is for parents of premature infants born at <=30.6 weeks gestation and have survived to 33 weeks, who spent time in the NICU at Parkland Hospital. Parents must speak English or Spanish. It's not for those with CPS involvement or whose babies have significant congenital anomalies.Check my eligibility
What is being tested?
The study tests if cognitive behavioral therapy (CBT) sessions for parents can improve outcomes for both them and their prematurely born infants after NICU stay.See study design
What are the potential side effects?
Cognitive Behavioral Therapy generally does not involve physical side effects but may sometimes cause temporary emotional discomfort due to discussing sensitive issues.
PreVNT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from discharge from parkland nicu until completion of the study at 6-9 months age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from discharge from parkland nicu until completion of the study at 6-9 months age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
mean value score Vulnerable Baby Scale (VBSc) Score
Secondary outcome measures
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
Correlation between changes over time in Vulnerable Baby Scale (VBSc) vs. Vulnerable Child Scale (VCSc) scores
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.
+3 moreSide effects data
From 2021 Phase 4 trial • 12 Patients • NCT041359378%
irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
MESH
PreVNT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention CBT ArmExperimental Treatment1 Intervention
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.
Group II: Control ArmActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy
2016
Completed Phase 4
~3120
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,051 Previous Clinical Trials
1,054,659 Total Patients Enrolled
Stanford UniversityOTHER
2,398 Previous Clinical Trials
17,341,983 Total Patients Enrolled
Margaret K Hoge, MDPrincipal InvestigatorUT Southwestern Medical Center Dallas
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You were born with major physical abnormalities.I (or my child's other parent) speak English or Spanish.You need to have survived until you are 33 weeks pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Intervention CBT Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants currently being accepted for this research trial?
"Affirmative. The clinicaltrial.gov portal reveals that this medical trial, which was initially posted on April 15th 2019, is actively enrolling patients. Approximately 100 individuals must be enrolled from a single site."
Answered by AI
What is the aggregate amount of participants in this clinical experiment?
"Indeed, the information found on clinicaltrials.gov implies that recruitment for this research is ongoing. It was initially advertised in April of 2019 and its details were most recently updated a few weeks ago. 100 individuals are required from 1 location to complete the trial."
Answered by AI
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