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 trial explores whether cognitive behavioral therapy (CBT) sessions for parents can improve outcomes for both the parents and their premature infants who have spent time in the neonatal intensive care unit (NICU). The study compares standard care with an added focus on helping parents cope with past NICU trauma and develop better emotional and parenting skills through CBT. Parents of infants born prematurely at Parkland Hospital, who speak English or Spanish and whose baby survived past 33 weeks of gestation, might be good candidates for this trial. This unphased trial offers an opportunity to contribute to valuable research that could enhance support for similar families.

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.

What prior data suggests that parent cognitive behavioral therapy is safe for families of premature infants?

Research shows that Cognitive Behavioral Therapy (CBT) is generally safe for parents of premature babies. Studies have found that CBT can help reduce feelings of stress and anxiety in these parents, indicating that the treatment is well-tolerated. No evidence of serious side effects from CBT has been found in these situations. For those considering joining a trial involving CBT for parents, current data supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Parent Cognitive Behavioral Therapy (CBT) because it offers a unique way to support families of premature infants. Unlike the standard care that mainly provides medical information and support, this approach directly addresses the emotional trauma and stress that parents experience in the NICU. Parent CBT includes targeted sessions that help parents process their experiences, improve their emotional resilience, and develop effective coping and parenting skills. This emotional and psychological focus is a fresh angle compared to traditional care, which tends to concentrate more on medical and logistical aspects. By empowering parents emotionally, researchers hope to enhance overall family well-being and potentially improve outcomes for premature infants.

What evidence suggests that parent cognitive behavioral therapy is effective for improving outcomes for premature infants' families?

Research has shown that cognitive behavioral therapy (CBT) can help reduce depression in parents of premature babies after hospital discharge. In this trial, one group of participants will receive standard care information, while another group will receive additional CBT sessions. Studies have also shown that group trauma-focused CBT can lower stress in these parents, potentially reducing anxiety and increasing feelings of control after sessions. Furthermore, early interventions like CBT can lead to better outcomes for babies born very early or with low birth weight. Overall, CBT offers promising benefits for both parents and their premature babies. ^{1 2 3 6 7}

Who Is on the Research Team?

Margaret K Hoge, MD

Principal Investigator

UT Southwestern Medical Center Dallas

Roy Heyne, MD

Principal Investigator

UT Southwestern Medical Center Dallas

Richard J Shaw, MD

Principal Investigator

Stanford University

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3925006/

Effectiveness of therapeutic behavioral interventions for ... Infants and children who were premature are more likely to have poorer cognitive and developmental functioning and, thus, may be harder to ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0378378223000695

Group trauma focused cognitive behavior therapy for ... Group therapy using trauma focused CBT is an effective intervention to reduce symptoms of psychological distress in parents of premature infants.

3. withpower.com withpower.com/trial/phase-substance-related-disorders-3-2019-675e1

Cognitive Behavioral Therapy for Premature Infants' Families Research shows that brief cognitive-behavioral interventions can help reduce depressive symptoms in mothers of premature infants after hospital discharge.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2821235

Parent-Guided Developmental Intervention for Infants With ... Parent-guided early intervention can improve neurodevelopmental outcome of very preterm or very low birth weight infants born in LMICs.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10182567/

Group Trauma Focused Cognitive Behavior Therapy for ... Conclusions: Group-based trauma focused CBT is an effective treatment modality for parents of premature infants with symptoms of psychological distress but not ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02835612

Early Intervention Program for Preterm Infants and Their ... Early intervention for high risk preterm infant must focus in the parents-infant relationship, environment and behavioral attitudes. It is possible that a ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2860291/

Parent-Child Interaction Therapy for Children Born Premature Results suggest that PCIT is a promising psychosocial intervention for children born premature with externalizing behavior problems, and that vagal tone may be ...