RecruitingNot Applicable

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

United States100 participantsStarted 2019-04-15

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Born at Parkland Hospital * English or Spanish speaking mother +/- father * ≤ 30.6 weeks gestation at birth * Survival to 33 weeks gestation Exclusion Criteria: * Significant congenital anomalies * Child Protective Services (CPS) involvement or foster care placement -- Prior enrollment in this PreVNT study for an older sibling.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

mean value score Vulnerable Baby Scale (VBSc) Score

Timeframe: 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

Trial details

NCT IDNCT03906435

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Margaret K Hoge, MD

214-617-8439 margaret.hoge@utsouthwestern.edu

View on ClinicalTrials.gov More Premature Infant trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.