Parenting Intervention for Preterm Birth

(I2P-RCT Trial)

Overseen By Kaylen McCullough, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Under 18, Unstable caregiving, Psychiatric hospitalization, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

Many children born very preterm experience behavior problems, and existing resources for parenting these children are lacking. A pilot trial established the effectiveness of a preterm parenting intervention, I-Interact Preterm (I2P). This study proposes a three-arm randomized controlled trial (RCT) comparing the established seven-session I2P program, a microlearning delivery mode (I2P-Micro), and an internet resource comparison group (IRC). Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment I-InTERACT Parenting Intervention (I2P) and I-InTERACT Parenting Microlearning Intervention (I2P Micro) for preterm birth?

Research shows that parenting interventions for preterm infants can improve child behavior and reduce parental stress, especially when they focus on the mother-infant relationship. These interventions have been found to have positive effects on both child development and parental well-being. ^{1 2 3 4 5}

Is the I-InTERACT Parenting Intervention safe for humans?

The available research on similar parenting interventions for preterm infants suggests they are generally safe and can reduce parental stress and improve child behavior, but specific safety data for the I-InTERACT Parenting Intervention is not provided. ^{2 4 5 6 7}

How does the I-InTERACT Parenting Intervention (I2P) treatment differ from other treatments for preterm birth?

The I-InTERACT Parenting Intervention (I2P) is unique because it focuses on enhancing parent-infant interaction and reducing parental stress through a structured program, which is not typically addressed by standard care. This approach is particularly beneficial for parents of preterm infants, as it helps them better understand and respond to their baby's cues, potentially improving both parental well-being and infant development. ^{2 4 5 6 7}

Research Team

Shari Wade, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

This trial is for parents of very preterm children who are facing behavior problems. It's designed to help improve parenting skills, the parent-child relationship, and manage problematic behaviors in these children.

Inclusion Criteria

English is the main language spoken in my home.

I was born before 32 weeks of pregnancy.

Total T score of > 55 on the Child Behavior Checklist Total or Externalizing Behavior Scales OR Total T score of > 55 on the Eyberg Child Behavior Inventory total problem- or total intensity-scale

Exclusion Criteria

I am under 18 years old.

My child lives with me at least half the time and our caregiving situation is stable.

English is not the primary language spoken in the home

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the I2P or I2P-Micro program with weekly or biweekly therapist coaching

12 weeks

Weekly or biweekly sessions with a therapist

Follow-up

Participants are monitored for parenting behaviors, child behavior problems, and parent distress

6 months

Assessments at 3 months and 6 months post-randomization

Treatment Details

Interventions

• I-InTERACT Parenting Intervention (I2P)
• I-InTERACT Parenting Microlearning Intervention (I2P Micro)

Trial Overview The study tests two versions of the I-InTERACT Parenting Intervention (I2P): a full seven-session program and a microlearning version (I2P Micro), against just using internet resources. The effectiveness will be measured over time with follow-ups.

Participant Groups

Group I: Internet Resource Group Experimental Treatment 1 Intervention

Control condition

Group II: I-InTERACT Microlearning Intervention (I2P-Micro) with regularly scheduled therapist coaching Active Control 1 Intervention

Group III: I-InTERACT Intervention (I2P) with regularly scheduled therapist coaching Active Control 1 Intervention

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Findings from Research

A systematic review of 17 studies found that eight different parenting interventions significantly improved the quality of the relationship between mothers and their preterm infants, highlighting the effectiveness of these programs.

The review suggests the need for a new integrated parenting program that emphasizes cue-based, responsive care to further enhance the mother-infant relationship, given the variety of interventions studied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are parenting interventions effective in improving the relationship between mothers and their preterm infants? Evans, T., Whittingham, K., Sanders, M., et al.[2022]

The Mother-Infant Transaction program (MITP) significantly reduced postpartum depression in mothers of preterm infants one month after discharge and increased breastfeeding duration at 9 months, indicating its efficacy in supporting maternal mental health and breastfeeding practices.

However, the intervention did not show significant improvements in total parenting stress or perceived infant communication skills at 12 months, suggesting that while MITP has benefits, it may not address all aspects of parenting challenges for mothers of preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of early mother-infant intervention on outcomes in mothers and moderately and late preterm infants at age 1 year: a randomized controlled trial. Ravn, IH., Smith, L., Smeby, NA., et al.[2015]

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 CareToy intervention, an individualized home-based program for preterm infants, significantly reduced parenting stress in mothers compared to Standard Care, as measured by the Parenting Stress Index-Short Form after 4 weeks.

While mothers showed a notable decrease in parental distress, fathers did not experience significant changes, highlighting the greater impact of the CareToy program on mothers who were more involved in the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on Parental Stress of Early Home-Based CareToy Intervention in Low-Risk Preterm Infants. Sgandurra, G., Beani, E., Inguaggiato, E., et al.[2020]

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 Stockholm Preterm Interaction-Based Intervention (SPIBI) trial aims to support extremely preterm infants and their parents through a structured program of home visits and support, focusing on enhancing parent-child interactions and parental sensitivity, with outcomes assessed at multiple developmental stages up to 36 months.

If successful, the SPIBI intervention could lead to improved emotional availability and developmental outcomes for EPT children, potentially influencing clinical practices and policies for early interventions in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stockholm preterm interaction-based intervention (SPIBI) - study protocol for an RCT of a 12-month parallel-group post-discharge program for extremely preterm infants and their parents. Baraldi, E., Allodi, MW., Löwing, K., et al.[2022]

A new intervention program has been developed specifically for parents of moderate to late preterm infants to enhance parent-infant interactions, which are crucial for the infants' development and attachment.

The program provides real-time feedback to parents during care routines, helping them recognize and respond to their infant's cues, with ongoing clinical studies assessing its effectiveness and parental experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Early Collaborative Intervention Focusing on Parent-Infant Interaction in the Neonatal Period. A Descriptive Study of the Developmental Framework. Helmer, CS., Thornberg, UB., Mörelius, E.[2021]

References

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

Are parenting interventions effective in improving the relationship between mothers and their preterm infants? [2022]

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

Effects of early mother-infant intervention on outcomes in mothers and moderately and late preterm infants at age 1 year: a randomized controlled trial. [2015]

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

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

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

Effects on Parental Stress of Early Home-Based CareToy Intervention in Low-Risk Preterm Infants. [2020]

5. 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]

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

Stockholm preterm interaction-based intervention (SPIBI) - study protocol for an RCT of a 12-month parallel-group post-discharge program for extremely preterm infants and their parents. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

An Early Collaborative Intervention Focusing on Parent-Infant Interaction in the Neonatal Period. A Descriptive Study of the Developmental Framework. [2021]