Premature InfantPreVNTNCT03906435
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
A study testing Cognitive Behavioral Therapy in people with Premature Infant and Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Development, Child
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Born at Parkland Hospital
- English or Spanish speaking mother +/- father
- ≤ 30.6 weeks gestation at birth
- Survival to 33 weeks gestation
Who cannot join
- Significant congenital anomalies
- Child Protective Services (CPS) involvement or foster care placement -- Prior enrollment in this PreVNT study for an older sibling.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Roy Heyne, MD contact
United States1 site, 1 recruiting
- Recruiting
Parkland Health & Hospital System
Dallas, Texas, 75235
Margaret K Hoge, MD, 405-596-2075, margaret.hoge@utsouthwestern.edu
Roy Heyne, MD, roy.heyne@utsouthwestern.edu
About this study
Official title: Parental Perception of Child Vulnerability in the NICU and Development Outcomes: A Randomized Control Trial Preventative Intervention With Cognitive Behavioral Therapy
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.
Read the detailed description
The NICU is a stressful experience for parents. This stress naturally affects parents in different ways, ranging from feelings of depression, anxiety, or post traumatic stress disorder (PTSD). While these feelings are very common in parents of NICU children, they can also impact the ways parents perceive their infants, which leads to alterations of parenting styles and exposure to developmental activities for growing infants. This phenomenon is well described in the literature as Vulnerable Child Syndrome (VCS), or Parent Perceived Child Vulnerability (PPCV) to illness. Traumatic events from earlier experiences in the NICU usually cause PPCV to occur. Examples of traumatic events include feared death of the child, which lead to parent anxiety, depression, or emotional trauma. This altered perception of the child has been linked to worsened development outcomes for NICU children further out into childhood and also continued feelings of depression, anxiety, or fear in the parents and lack of confidence in their parenting abilities.
CBT sessions have been proven beneficial for NICU parents by decreasing feelings of depression, anxiety, and PTSD. However, there has not been research to see if CBT sessions are impactful for PPCV and the impacts it has on parent and child outcomes. Since literature suggests that depression, anxiety, and PTSD play an integral role in the development of PPCV and VCS, it could be assumed that CBT sessions should also be beneficial for PPCV and VCS. Therefore, this study will research if CBT sessions can improve parent-child interactions before and after discharge by helping parents to better understand their child's health and empower them with confidence in parenting skills. It will also evaluate if the effects of the CBT sessions will remain present and beneficial for parents' perceptions over time. With the results of this study, it will be evaluated if it is possible to improve the care for parents and children in the NICU as well as the long-term outcomes of parents and NICU children through CBT.
This will be a randomized control trial and will be conducted to assess the outcomes of infants and parents receiving either CBT sessions versus standard of care.
English and/or Spanish speaking parents of infants born at 30.6 weeks gestational age (GA) or less who survive to 33 weeks GA will be eligible to participate in the study. Families will be approached at 33 weeks GA to participate in the study. Once enrolled, the mother (and father, if willing to participate) will be randomized into a control group (standard NICU and follow up care information) versus the intervention group (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 delivered either in person or virtually). The CBT sessions will address PPCV and VCS in parents and parenting skills to address preventing 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. The investigators will look into the effects of in-person versus telehealth administration.
Scales used for assessment will be distributed at enrollment to the study and upon completion of the CBT sessions.
- Conditions
- Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Development, Child, Parent-Child Relations
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Vulnerable Child Syndrome, Neonatal Intensive Care Unit, Cognitive Behavioral Therapy, Parental Perception of Child Vulnerability, Child Developmental Outcomes, Parent Mental Health
- Medical subject headings
- Premature Birth, Depression, Psychotic Disorders, Personality Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No 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. |
| Intervention CBT Arm | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean value score Vulnerable Baby Scale (VBSc) Score
Measures parental perceptions of child vulnerability. It has been used for parents with infants as young as 10-12 weeks of age up through 6 months to a year old. It is a 10 question scale, with each question scored on a five point likert scale (1-5). Score range is 10-50. Maximum score of 50 possible. A score of 27 or more was the median score for a sample of medically fragile neonates, and signifies relatively high perceptions of vulnerability. While a score of 23 was the median for a sample of healthy controls and thus reflect a more normal perception of vulnerability (Kerruish et al 2005). The higher the score, the higher the perception of child vulnerability.
Measured: 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
Secondary outcomes (7)
differences over time in subsets of Vulnerable Baby Scale (VBSc) scores
The VBSc can be broken down into subsets of questions addressing parent 1) thoughts: 2 questions of 10 scale questions, scored 0-2; 2) feelings: 3 questions of 10 scale questions, scored 0-3; and 3) actions/behaviors: 5 questions out of 10 scale questions, scored 0-5. This quantifies the amounts of subsets of the scale that the parent endorses. Higher numbers are markers of more and worse perceptions of child vulnerability in each category of thought, feeling, and action/behavior.
Measured: measurement differences over time between the total number of questions endorsed for each of the three different question subsets of VBSc of the parents at baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age
Correlation between changes over time in Vulnerable Baby Scale (VBSc) vs. Vulnerable Child Scale (VCSc) scores
The VCSc is the most frequently and widely used scale to measure parent perceptions of vulnerability and Vulnerable Child Syndrome (VCS). It was modified by the author from the original 12 question scale to an 8 question scale. The modified scale has higher internal validity and consistency (Forsyth et al 1996). This scale was intended for and has been used for children aged mostly from 6 months to 8 years of age or older. Each question is scored on a four point likert scale (0-3). A total score of 0 to 24 is possible, the higher the score the more perceptions of vulnerability. A score of greater than 10 signifies high perceptions of vulnerability. See above for VBSc description.
Measured: measurement differences of scores from baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age
differences over time in parent depression scores measured with Beck Depression Inventory Scale- 2nd edition.
Beck Depression Inventory - 2nd Edition: This will be used to measure parent depression scores, which can be associated with development of VCS. This will be used as a secondary outcome in change over time throughout the study. This is a 21 item questionnaire, measured on a four point likert scale (0-3). A score of greater than 14 signifies depression, with higher scores representing more severe levels of depression. Scores of 0-13= No depression; 14-19= mild; 20-28= moderate; 29-63= severe.
Measured: measure differences of the scale's total score between timepoints at baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age
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.
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. Scored in number of total days in the NICU (0 to infinite number). The higher the number, the more lengthy the NICU stay.
Measured: Days will be counted that are spent in the NICU starting from the day of birth of the child which is the admission day to the NICU until discharge day that is documented from Parkland NICU, through study completion, an average of 1 year.
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
The electronic medical record will be evaluated for how many total sick visits or hospital admissions are documented each month post discharge at Children's Medical Center and any associated hospitals that share medical records on the electronic medical record. The total number of encounters will be averaged over the amount of months from NICU discharge until the end of the study. Routine health checks will not be included in this number. A higher number will signify higher health care system usage.
Measured: from discharge from Parkland NICU until completion of the study at 6-9 months age
differences over time in parent anxiety scores measured with Beck Anxiety Inventory Scale
Beck Anxiety Inventory: This will be used to measure parent anxiety scores, which can be associated with development of VCS. This will be used as a secondary outcome for change over time throughout the study. This is a 21 item questionnaire, measured on a four point likert scale (0-3). Possible scores range from 0-36. A score of greater than 7 suggests anxiety. Scores of 8-15= mild; 16-25= moderate; 26-36= severe.
Measured: measure differences of the scale's total score between timepoints at baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age
The Capute Scales: Cognitive Adaptive Test/Clinical Linguistic and Auditory Milestones Scale (CAT/CLAMS)
This is a neurodevelopmental tool used for children up through age 3 years old for cognitive assessment of infants and toddlers. It provides quantitative developmental quotients (DQ) for non-language visual motor (CAT DQ) and language (CLAMS DQ) abilities.
Measured: It will be administered at 6 months of age for all children enrolled in both study groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start15 Apr 2019
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a non-blinded randomized control to assess the outcomes of infants and parents receiving either Cognitive Behavioral Therapy (CBT) sessions focusing on NICU trauma, emotional responses, and parent perceptions of child vulnerability (PPCV) versus standard of care without CBT sessions. English and/or Spanish speaking parents of infants born at 30.6 weeks gestational age (GA) or less who survive to 33 weeks GA will be eligible to participate in the study. Once enrolled, the mother (and father, if willing) will be randomized into a control group (standard NICU and follow up care information) versus the intervention group (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 be standardized with a manual. Scales used for assessment will be distributed at enrollment to the study and upon completion of the CBT sessions.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Margaret Hoge, University of Texas Southwestern Medical Center
- Investigators
- Margaret K Hoge, MD, Principal investigator, UT Southwestern Medical Center DallasRoy Heyne, MD, Study director, UT Southwestern Medical Center DallasRichard J Shaw, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906435
- Sponsor's protocol ID
- STU 072018-095
- Acronym
- PreVNT
- Status last verified
- Jul 2026
- First submitted
- 19 Mar 2019
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There will be a data sharing agreement signed between all parties and institutions to agree to share data safely and confidentially if sharing is necessary. The data shared will be de-identified for the purposes of data analysis and result interpretation.
Publications
Kerruish NJ, Settle K, Campbell-Stokes P, Taylor BJ. Vulnerable Baby Scale: development and piloting of a questionnaire to measure maternal perceptions of their baby's vulnerability. J Paediatr Child Health. 2005 Aug;41(8):419-23. doi: 10.1111/j.1440-1754.2005.00658.x.
PubMed 16101975Forsyth BW, Horwitz SM, Leventhal JM, Burger J, Leaf PJ. The child vulnerability scale: an instrument to measure parental perceptions of child vulnerability. J Pediatr Psychol. 1996 Feb;21(1):89-101. doi: 10.1093/jpepsy/21.1.89.
PubMed 8820075Hoge MK, Heyne E, Brown S, Heyne R, Shaw RJ, Chalak L. Reduction of neonatal intensive care unit (NICU) parental perceptions of child vulnerability and risk of vulnerable child syndrome utilizing cognitive behavioral therapy: randomized controlled trial. Pediatr Res. 2026 Jan;99(1):254-262. doi: 10.1038/s41390-025-04094-x. Epub 2025 May 15.
PubMed 40374965
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Perception of Child Vulnerability in the NICU and Development Outcomes: A Randomized Control Trial Preventative Intervention With Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT03906435
- Acronym / sponsor ID
- PreVNT / STU 072018-095
- Conditions
- Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Development, Child, Parent-Child Relations
- Keywords
- Vulnerable Child Syndrome, Neonatal Intensive Care Unit, Cognitive Behavioral Therapy, Parental Perception of Child Vulnerability, Child Developmental Outcomes, Parent Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The NICU is a stressful experience for parents. This stress naturally affects parents in different ways, ranging from feelings of depression, anxiety, or post traumatic stress disorder (PTSD). While these feelings are very common in parents of NICU children, they can also impact the ways parents perceive their infants, which leads to alterations of parenting styles and exposure to developmental activities for growing infants. This phenomenon is well described in the literature as Vulnerable Child Syndrome (VCS), or Parent Perceived Child Vulnerability (PPCV) to illness. Traumatic events from earlier experiences in the NICU usually cause PPCV to occur. Examples of traumatic events include feared death of the child, which lead to parent anxiety, depression, or emotional trauma. This altered perception of the child has been linked to worsened development outcomes for NICU children further out into childhood and also continued feelings of depression, anxiety, or fear in the parents and lack of confidence in their parenting abilities.
CBT sessions have been proven beneficial for NICU parents by decreasing feelings of depression, anxiety, and PTSD. However, there has not been research to see if CBT sessions are impactful for PPCV and the impacts it has on parent and child outcomes. Since literature suggests that depression, anxiety, and PTSD play an integral role in the development of PPCV and VCS, it could be assumed that CBT sessions should also be beneficial for PPCV and VCS. Therefore, this study will research if CBT sessions can improve parent-child interactions before and after discharge by helping parents to better understand their child's health and empower them with confidence in parenting skills. It will also evaluate if the effects of the CBT sessions will remain present and beneficial for parents' perceptions over time. With the results of this study, it will be evaluated if it is possible to improve the care for parents and children in the NICU as well as the long-term outcomes of parents and NICU children through CBT.
This will be a randomized control trial and will be conducted to assess the outcomes of infants and parents receiving either CBT sessions versus standard of care.
English and/or Spanish speaking parents of infants born at 30.6 weeks gestational age (GA) or less who survive to 33 weeks GA will be eligible to participate in the study. Families will be approached at 33 weeks GA to participate in the study. Once enrolled, the mother (and father, if willing to participate) will be randomized into a control group (standard NICU and follow up care information) versus the intervention group (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 delivered either in person or virtually). The CBT sessions will address PPCV and VCS in parents and parenting skills to address preventing 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. The investigators will look into the effects of in-person versus telehealth administration.
Scales used for assessment will be distributed at enrollment to the study and upon completion of the CBT sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a non-blinded randomized control to assess the outcomes of infants and parents receiving either Cognitive Behavioral Therapy (CBT) sessions focusing on NICU trauma, emotional responses, and parent perceptions of child vulnerability (PPCV) versus standard of care without CBT sessions. English and/or Spanish speaking parents of infants born at 30.6 weeks gestational age (GA) or less who survive to 33 weeks GA will be eligible to participate in the study. Once enrolled, the mother (and father, if willing) will be randomized into a control group (standard NICU and follow up care information) versus the intervention group (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 be standardized with a manual. Scales used for assessment will be distributed at enrollment to the study and upon completion of the CBT sessions.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No 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. |
| Intervention CBT Arm | Experimental | Behavioral: Cognitive Behavioral TherapyIn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Born at Parkland Hospital
- English or Spanish speaking mother +/- father
- ≤ 30.6 weeks gestation at birth
- Survival to 33 weeks gestation
Key exclusion criteria (2 listed)
- Significant congenital anomalies
- Child Protective Services (CPS) involvement or foster care placement -- Prior enrollment in this PreVNT study for an older sibling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyThe 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. | Behavioural | Intervention CBT Arm |
Primary outcome
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
Measures parental perceptions of child vulnerability. It has been used for parents with infants as young as 10-12 weeks of age up through 6 months to a year old. It is a 10 question scale, with each question scored on a five point likert scale (1-5). Score range is 10-50. Maximum score of 50 possible. A score of 27 or more was the median score for a sample of medically fragile neonates, and signifies relatively high perceptions of vulnerability. While a score of 23 was the median for a sample of healthy controls and thus reflect a more normal perception of vulnerability (Kerruish et al 2005). The higher the score, the higher the perception of child vulnerability.
7 secondary outcomes
differences over time in subsets of Vulnerable Baby Scale (VBSc) scores
Time frame: measurement differences over time between the total number of questions endorsed for each of the three different question subsets of VBSc of the parents at baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age
Correlation between changes over time in Vulnerable Baby Scale (VBSc) vs. Vulnerable Child Scale (VCSc) scores
Time frame: measurement differences of scores from baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age
differences over time in parent depression scores measured with Beck Depression Inventory Scale- 2nd edition.
Time frame: measure differences of the scale's total score between timepoints at baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age
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.
Time frame: Days will be counted that are spent in the NICU starting from the day of birth of the child which is the admission day to the NICU until discharge day that is documented from Parkland NICU, through study completion, an average of 1 year.
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
Time frame: from discharge from Parkland NICU until completion of the study at 6-9 months age
differences over time in parent anxiety scores measured with Beck Anxiety Inventory Scale
Time frame: measure differences of the scale's total score between timepoints at baseline of the study (33 weeks post-menstrual age) versus at six to nine months of post-birth age
The Capute Scales: Cognitive Adaptive Test/Clinical Linguistic and Auditory Milestones Scale (CAT/CLAMS)
Time frame: It will be administered at 6 months of age for all children enrolled in both study groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Results publication: PubMed 16101975Kerruish NJ, Settle K, Campbell-Stokes P, Taylor BJ. Vulnerable Baby Scale: development and piloting of a questionnaire to measure maternal perceptions of their baby's vulnerability. J Paediatr Child Health. 2005 Aug;41(8):419-23. doi: 10.1111/j.1440-1754.2005.00658.x.
- Results publication: PubMed 8820075Forsyth BW, Horwitz SM, Leventhal JM, Burger J, Leaf PJ. The child vulnerability scale: an instrument to measure parental perceptions of child vulnerability. J Pediatr Psychol. 1996 Feb;21(1):89-101. doi: 10.1093/jpepsy/21.1.89.
- Derived from this study: PubMed 40374965Hoge MK, Heyne E, Brown S, Heyne R, Shaw RJ, Chalak L. Reduction of neonatal intensive care unit (NICU) parental perceptions of child vulnerability and risk of vulnerable child syndrome utilizing cognitive behavioral therapy: randomized controlled trial. Pediatr Res. 2026 Jan;99(1):254-262. doi: 10.1038/s41390-025-04094-x. Epub 2025 May 15.
- Individual participant dataSharing planned: Yes. There will be a data sharing agreement signed between all parties and institutions to agree to share data safely and confidentially if sharing is necessary. The data shared will be de-identified for the purposes of data analysis and result interpretation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roy Heyne, MD contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Premature Infant and Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret K Hoge, MD (214-617-8439, margaret.hoge@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906435, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.