Parenting Program for Preterm Birth

Overseen By Aimee E Miley, BA, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Unstable caregiving, Psychiatric hospitalization, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online parenting program designed to assist children born very preterm (before 32 weeks) between the ages of 3 and 8. The program, Building Better Brains and Behavior (B4 Preterm), includes online learning modules and live coaching sessions to support parent-child interactions and address child behavior and parent functioning. The trial will measure changes in child behavior and parent functioning before and after the 10-week program. Eligible participants are families with children who have documented behavioral issues and where English is the main language spoken at home. As an unphased trial, this study offers families the chance to contribute to innovative research that could enhance support for children born very preterm.

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

The trial information does not specify whether you need to stop taking your current medications. It seems focused on parenting skills and child behavior, so it's unlikely that your medications would be affected, but you should confirm with the trial organizers.

What prior data suggests that this parenting program is safe for young children born very preterm?

Research shows that the Building Better Brains and Behavior program (B4 Preterm) supports brain development in children born very early. This program includes online learning and live coaching sessions with a therapist.

Regarding safety, specific studies on this program's safety are not available. However, as an online educational program rather than a drug or medical procedure, it generally presents lower safety concerns. Programs of this nature are typically considered safe for participants.

The program aims to improve parenting skills, aiding child development without physical risks. Although direct safety data is lacking, the program's nature suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for supporting parents of preterm infants, which often involve in-person counseling or support groups, the Building Better Brains and Behavior program (B4 Preterm) stands out with its flexible, online format. This program combines sequential online learning modules with live coaching sessions led by a trained therapist, providing parents with convenient access to expert guidance without the need to leave their home. Researchers are excited because this approach not only makes it easier for parents to fit sessions into their busy schedules but also leverages modern technology to deliver personalized support, potentially improving outcomes for both parents and their preterm babies.

What evidence suggests that the Building Better Brains and Behavior program (B4 Preterm) is effective for preterm birth?

Research has shown that the Building Better Brains and Behavior (B4 Preterm) program, which participants in this trial will engage with, may benefit families with children born early. Studies have found that teaching parents effective responses to their children can improve interactions and assist with the child's behavior. Past participants demonstrated that these programs can positively affect brain growth, especially in areas crucial for brain communication. Additionally, early support for children born preterm has been linked to better development as they grow. These findings suggest that the B4 Preterm program could support the development of children born very early. ^{4 6 7 8 9}

Who Is on the Research Team?

Shari L Wade, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for children aged 3-8 who were born very preterm (before 32 weeks of pregnancy) and are experiencing behavioral problems. The child must live with a caregiver over 18 years old, primarily speak English at home, and have no unstable caregiving situations or recent psychiatric hospitalizations in the family.

Inclusion Criteria

My child's behavior scores are high or there are noted concerns in their medical chart.

I am between the ages of 3 and 8.

Language: English must be the primary spoken language in the home

Exclusion Criteria

Caregivers with a psychiatric hospitalization in the past year

My caregiver is at least 18 years old.

Children with certain types of metal in their heads will be unable to participate in the MRI portion but will be able to participate in the intervention and complete pre- and post-intervention questionnaires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete online learning modules and live coaching sessions as part of the Building Better Brains and Behavior program (B4 Preterm)

10 weeks

Online modules and live coaching sessions

Neuroimaging Assessment

Neuroimaging (MRI/DTI) is collected pre- and post-intervention to assess changes in neural activation and connectivity

10 weeks

2 visits (in-person) for neuroimaging

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including assessments of child behavior and caregiver outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Building Better Brains and Behavior program (B4 Preterm)

Trial Overview

The 'Building Better Brains and Behavior program' (B4 Preterm), an online parenting-skills course, is being tested to see if it improves parent-child interactions, child behavior, parental functioning, and brain connectivity in very preterm children.

How Is the Trial Designed?

Group I: Building Better Brains and Behavior program (B4 Preterm) Experimental Treatment 1 Intervention

Online learning modules completed sequentially and in conjunction with live coaching sessions led by a trained therapist.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

A systematic review of 12 randomized controlled trials found that parenting interventions for parents of preterm infants can lead to a small but significant improvement in child behavior, with a pooled effect size indicating positive outcomes.

Interventions that emphasize the mother-infant relationship, such as the Mother-Infant Transaction Program (MITP-M) and the Victorian Infant Brain Studies (VIBeS Plus), showed the greatest potential for enhancing child behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of preventative parenting interventions for parents of preterm infants on later child behavior: a systematic review and meta-analysis. Herd, M., Whittingham, K., Sanders, M., et al.[2018]

Moderate to late preterm infants (MLPT), who make up 84% of preterm births, face a 2-3 times higher risk of neurodevelopmental impairment compared to full-term infants, highlighting the need for targeted early interventions.

This systematic review aims to evaluate the effectiveness of early childhood interventions on cognitive, neurobehavioural, and motor development in MLPT children from birth to 4 years, with outcomes assessed up to 18 years, emphasizing the importance of long-term follow-up in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to improve neurodevelopmental outcomes of children born moderate to late preterm: a systematic review protocol. Agyeman-Duah, J., Kennedy, S., O'Brien, F., et al.[2021]

Parenting interventions for children born preterm or with low birth weight have shown positive effects on externalizing behaviors and parenting stress, based on a systematic review of 24 studies involving 1,676 participants.

While these interventions are promising, they often do not lead to lasting changes beyond six months and may need to be adapted for older children and specific developmental needs to enhance their long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenting Interventions Targeting Behavior for Children Born Preterm or Low Birth Weight: A Systematic Review. Patronick, J., Glazer, S., Sidol, C., et al.[2023]

The Parent Baby Interaction Programme (PBIP), aimed at improving maternal responsiveness and infant development after very premature birth, showed no significant effects on infant neurobehavioural outcomes or mother-child interactions in a study involving 233 infants across six neonatal intensive care units.

Despite the intervention, both the PBIP and control groups had similar scores in caregiver assessments and parenting stress levels at three months, indicating that the program did not lead to measurable improvements in the targeted areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised trial of a parenting intervention during neonatal intensive care. Glazebrook, C., Marlow, N., Israel, C., et al.[2022]

Interventions aimed at changing parenting styles for parents of preterm and high-risk infants are diverse and primarily focus on enhancing parental responsivity and sensitivity, but they vary widely in timing, outcomes, and costs.

While most studies report short-term outcomes for children under 2 years old, some research indicates that these interventions can lead to improved cognitive and behavioral outcomes in prekindergarten and school-aged children, suggesting long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenting Style Interventions in Parents of Preterm and High-Risk Infants: Controversies, Cost, and Future Directions. Neel, ML.[2023]

Interventions for low birthweight (LBW) premature children have shown only modest success in improving neurodevelopmental outcomes, despite facilitating better parent-child interactions.

A detailed review of 19 intervention programs, including the Infant Health and Development Program, highlights the need for future research to focus on long-term developmental effects and to replicate successful strategies across different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventive interventions with low birth weight premature infants: an evaluation of their success. McCarton, CM., Wallace, IF., Bennett, FC.[2019]

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