RECRUITING

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

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Conditions

Premature InfantMental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)Development, ChildParent-Child RelationsVulnerable Child SyndromeNeonatal Intensive Care UnitCognitive Behavioral TherapyParental Perception of Child VulnerabilityChild Developmental OutcomesParent Mental Health

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Parental Perception of Child Vulnerability in the NICU and Development Outcomes: A Randomized Control Trial Preventative Intervention With Cognitive Behavioral Therapy

Quick Facts

Study Start:2019-04-15
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03906435

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Born at Parkland Hospital
  2. * English or Spanish speaking mother +/- father
  3. * ≤ 30.6 weeks gestation at birth
  4. * Survival to 33 weeks gestation
  1. * Significant congenital anomalies
  2. * Child Protective Services (CPS) involvement or foster care placement -- Prior enrollment in this PreVNT study for an older sibling.

Contacts and Locations

Study Contact

Margaret K Hoge, MD
CONTACT
214-617-8439
margaret.hoge@utsouthwestern.edu
Roy Heyne, MD
CONTACT
roy.heyne@utsouthwestern.edu

Principal Investigator

Margaret K Hoge, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center Dallas
Roy Heyne, MD
STUDY_DIRECTOR
UT Southwestern Medical Center Dallas
Richard J Shaw, MD
STUDY_DIRECTOR
Stanford University

Study Locations (Sites)

Parkland Health & Hospital System
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Margaret K Hoge, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center Dallas
  • Roy Heyne, MD, STUDY_DIRECTOR, UT Southwestern Medical Center Dallas
  • Richard J Shaw, MD, STUDY_DIRECTOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-15
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2019-04-15
Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

  • Vulnerable Child Syndrome
  • Neonatal Intensive Care Unit
  • Cognitive Behavioral Therapy
  • Parental Perception of Child Vulnerability
  • Child Developmental Outcomes
  • Parent Mental Health

Additional Relevant MeSH Terms

  • Premature Infant
  • Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
  • Development, Child
  • Parent-Child Relations