Recruiting

Cognitive Behavioral Therapy

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT03906435

Conditions

Premature Infant

Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)

Development, Child

Parent-Child Relations

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Cognitive Behavioral Therapy

Study Details

Brief 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.

Conditions

Premature Infant

Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)

Development, Child

Parent-Child Relations

Study ID

NCT03906435

Start date

Apr 15, 2019

Status verified date

Jul, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control Arm

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.

experimental: Intervention CBT Arm

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.

Interventions

Cognitive Behavioral Therapy

The intervention group will receive standard NICU and follow up care information plus a total of 5 CBT sessions split between the NICU and outpatient clinic visits post discharge from NICU. The CBT sessions will address PPCV in parents and parenting skills to address this. The CBT sessions will be standardized with a manual for study investigators to follow during sessions, and made with Dr. Richard Shaw from Stanford University, who wrote the prior CBT manual for anxiety, depression, and PTSD for NICU parents. Study staff will be trained to give the standardized CBT sessions using the manual via pilot sessions. There will be 3 CBT sessions given in the Parkland NICU before discharge and then 2 in the THRIVE follow up clinic at Children's Medical Center after discharge from the NICU.

Primary outcome measure

  • mean value score Vulnerable Baby Scale (VBSc) Score [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Margaret K Hoge, MD

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

Roy Heyne, MD

roy.heyne@utsouthwestern.edu

Locations

Parkland Health & Hospital System

Recruiting

Dallas, Texas, United States, 75235

Contacts

Margaret K Hoge, MD

405-596-2075margaret.hoge@utsouthwestern.edu

Roy Heyne, MD

roy.heyne@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-07-09.