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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

No Placebo-Only Group

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from discharge from parkland nicu until completion of the study at 6-9 months age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

mean value score Vulnerable Baby Scale (VBSc) Score

Secondary study objectives

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 more

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT04135937

irritability

100%

80%

60%

40%

20%

Study treatment Arm

MESH

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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