Cognitive Behavioral Therapy for Premature Infants' Families

(PreVNT Trial)

Overseen By Roy Heyne, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Congenital anomalies, CPS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6-9 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is Cognitive Behavioral Therapy safe for parents of premature infants?

Cognitive Behavioral Therapy (CBT) has been studied in parents of premature infants and is generally considered safe. It has been shown to help reduce symptoms of anxiety, depression, and post-traumatic stress without any reported harmful effects. ^{1 2 3 4 5}

How does Parent Cognitive Behavioral Therapy differ from other treatments for families of premature infants?

Parent Cognitive Behavioral Therapy is unique because it focuses on helping parents of premature infants manage stress, anxiety, and depression by changing negative thoughts and behaviors. Unlike other treatments, it specifically targets the psychological impact of having a premature infant, aiming to reduce symptoms of posttraumatic stress and improve mental health. ^{2 3 4 5 6}

What data supports the effectiveness of the treatment Parent Cognitive Behavioral Therapy for families of premature infants?

Research shows that brief cognitive-behavioral interventions can help reduce depressive symptoms in mothers of premature infants after hospital discharge. Additionally, educational-behavioral programs like COPE have been effective in improving parent mental health outcomes and enhancing parent-infant interactions. ^{1 2 3 5 6}

Who Is on the Research Team?

Richard J Shaw, MD

Principal Investigator

Stanford University

Margaret K Hoge, MD

Principal Investigator

UT Southwestern Medical Center Dallas

Roy Heyne, MD

Principal Investigator

UT Southwestern Medical Center Dallas

Are You a Good Fit for This Trial?

This trial is for parents of premature infants born at <=30.6 weeks gestation and have survived to 33 weeks, who spent time in the NICU at Parkland Hospital. Parents must speak English or Spanish. It's not for those with CPS involvement or whose babies have significant congenital anomalies.

Inclusion Criteria

Born at Parkland Hospital

<= 30.6 weeks gestation at birth

You need to have survived until you are 33 weeks pregnant.

Exclusion Criteria

You were born with major physical abnormalities.

Child Protective Services (CPS) involvement or foster care placement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Parents receive 5 CBT sessions to address PPCV and VCS, with 3 sessions in the NICU and 2 sessions post-discharge

6-9 months

3 visits (in-person) in NICU, 2 visits (in-person or virtual) post-discharge

Follow-up

Participants are monitored for changes in parental perceptions and child development outcomes

6-9 months

Regular follow-up visits

Long-term follow-up

Evaluation of long-term outcomes for parents and children post-NICU discharge

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Parent Cognitive Behavioral Therapy

Trial Overview The study tests if cognitive behavioral therapy (CBT) sessions for parents can improve outcomes for both them and their prematurely born infants after NICU stay.

How Is the Trial Designed?

Group I: Intervention CBT Arm Experimental Treatment 1 Intervention

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.

Group II: Control Arm Active Control 1 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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A pilot study involving 56 mothers of hospitalized premature infants found that a brief cognitive-behavioral intervention may help reduce depressive symptoms one month after their infant's discharge, showing a trend towards lower depression levels in the intervention group (p = .06).

Despite the intervention, levels of traumatic symptoms remained similar between the intervention and control groups, suggesting that while cognitive-behavioral strategies may be beneficial for depression, they may not be as effective for trauma-related symptoms in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief cognitive-behavioral intervention for maternal depression and trauma in the neonatal intensive care unit: a pilot study. Bernard, RS., Williams, SE., Storfer-Isser, A., et al.[2018]

A structured psychological intervention program for mothers of premature infants in a NICU significantly reduced symptoms of trauma related to premature birth, with intervention group mothers reporting lower symptom levels (mean 25.2) compared to control group mothers (mean 37.5).

The program included early crisis intervention and ongoing psychological support, demonstrating its efficacy in helping parents cope with the emotional challenges of having a premature infant during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping parents cope with the trauma of premature birth: an evaluation of a trauma-preventive psychological intervention. Jotzo, M., Poets, CF.[2006]

The 'Creating Opportunities for Parent Empowerment' program significantly reduced maternal stress, depression, and anxiety in parents of preterm infants, leading to improved mental health outcomes by 2 months after discharge.

Infants whose parents participated in the program had a shorter NICU stay by an average of 3.8 days and a total hospital stay that was 3.9 days shorter compared to those in the comparison group, indicating the program's efficacy in enhancing parent-infant interactions and reducing hospitalization time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing premature infants' length of stay and improving parents' mental health outcomes with the Creating Opportunities for Parent Empowerment (COPE) neonatal intensive care unit program: a randomized, controlled trial. Melnyk, BM., Feinstein, NF., Alpert-Gillis, L., et al.[2022]

A study involving 213 families of premature infants evaluated the effects of music therapy on mother-infant bonding, parental anxiety, and maternal depression, but found no significant differences between the music therapy group and the standard care group at discharge.

Despite the music therapy sessions being well-received, with 98% of participants completing the treatment, the results indicated that parent-led singing did not improve bonding or reduce anxiety and depression among parents compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial. Gaden, TS., Ghetti, C., Kvestad, I., et al.[2022]

A 6-session intervention for mothers of preterm infants significantly reduced trauma symptoms (Cohen's d = 0.41) and depression (Cohen's d = 0.59) compared to a comparison group, indicating its efficacy in addressing mental health issues in this population.

The intervention was particularly beneficial for mothers experiencing higher levels of NICU stress, suggesting that targeted support can lead to better outcomes for both mothers and their infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of traumatic stress in mothers with preterm infants: a randomized controlled trial. Shaw, RJ., St John, N., Lilo, EA., et al.[2022]

Cognitive-Behavioral Therapy (CBT) significantly reduced levels of anxiety and PTSD in mothers of preterm infants, based on a systematic review of four clinical trials involving 455 mothers.

While CBT showed a trend towards reducing depression scores, this result was not statistically significant, indicating that more research is needed to confirm its efficacy in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of cognitive-behavioral therapy on psychological distress in the mothers of preterm infants: a systematic review and meta-analysis. Seiiedi-Biarag, L., Mirghafourvand, M., Ghanbari-Homayi, S.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Brief cognitive-behavioral intervention for maternal depression and trauma in the neonatal intensive care unit: a pilot study. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Helping parents cope with the trauma of premature birth: an evaluation of a trauma-preventive psychological intervention. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Reducing premature infants' length of stay and improving parents' mental health outcomes with the Creating Opportunities for Parent Empowerment (COPE) neonatal intensive care unit program: a randomized, controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Prevention of traumatic stress in mothers with preterm infants: a randomized controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The effect of cognitive-behavioral therapy on psychological distress in the mothers of preterm infants: a systematic review and meta-analysis. [2021]