Using cognitive behavioral therapy to help parents of premature infants in the NICU
Official title: Parental Perception of Child Vulnerability in the NICU and Development Outcomes: A Randomized Control Trial Preventative Intervention With Cognitive Behavioral Therapy
Run by University of Texas Southwestern Medical Center · NCT03906435 · Data updated 2026-11-12
This study is testing whether cognitive behavioral therapy can help parents of premature infants in the NICU feel less anxious and depressed, which may improve their relationship with their child and the child's development.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | April 15, 2019 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT03906435 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are parents of infants born at Parkland Hospital who are English or Spanish speaking and whose infants were born at or before 30.6 weeks gestation.
✕Probably not a fit
Patients with significant congenital anomalies or those involved with Child Protective Services may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to improve outcomes for both parents and their premature infants who have spent time in the neonatal intensive care unit (NICU) through cognitive behavioral therapy (CBT) sessions for parents. The NICU experience can lead to significant stress and mental health issues for parents, which may alter their perceptions of their child's vulnerability and impact parenting styles. By addressing these mental health challenges, the study seeks to mitigate the effects of Vulnerable Child Syndrome (VCS) and enhance developmental outcomes for infants. The research will evaluate the effectiveness of CBT in reducing parental anxiety, depression, and PTSD, and its subsequent impact on parent-child relationships.
Why it matters
Potential benefit: If successful, this approach could lead to improved mental health for parents and better developmental outcomes for their premature infants.
How similar studies have gone: Previous studies have shown that cognitive behavioral therapy can effectively reduce anxiety and depression in NICU parents, suggesting potential success for this approach in addressing VCS.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Parkland Health & Hospital System
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Margaret K Hoge, MD — UT Southwestern Medical Center Dallas
- Study coordinator: Margaret K Hoge, MD
- Email: margaret.hoge@utsouthwestern.edu
- Phone: 214-617-8439
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.