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

19 Participants Needed

Trial Summary

What is the purpose of this trial?

Open pilot of a brief online parenting-skills intervention for young children ages 3-8 who were born very preterm (\< 32 weeks gestational age). Parent-child interactions, child behavior, parent functioning, and child white matter connectivity will be assessed pre- and post-intervention 10 weeks later.

Is the Parenting Program for Preterm Birth safe for humans?

The reviewed studies on parenting interventions for preterm infants, such as the Infant Health and Development Program and others, indicate that these programs are generally safe and can improve parent-child interactions and child behavior. ^{1 2}

How is the B4 Preterm treatment different from other treatments for preterm birth?

The B4 Preterm treatment is unique because it focuses on improving the parent-infant relationship and enhancing child behavior through a structured parenting program, unlike other treatments that may not emphasize this aspect. It is designed specifically for parents of preterm infants to support better developmental outcomes. ^{3 4 5 6 7}

Research Team

Shari L Wade, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Preventive interventions with low birth weight premature infants: an evaluation of their success. [2019]

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

Interventions to improve neurodevelopmental outcomes of children born moderate to late preterm: a systematic review protocol. [2021]

3. United States 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. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Influences of a dedicated parental training program on parent-child interaction in preterm infants. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Randomised trial of a parenting intervention during neonatal intensive care. [2022]

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

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

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

Parenting Interventions Targeting Behavior for Children Born Preterm or Low Birth Weight: A Systematic Review. [2023]