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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help parents manage behavior problems in children born very preterm. It tests two versions of the I-InTERACT Parenting Intervention (I2P): a seven-session format and a shorter microlearning format. The goal is to determine which approach more effectively reduces child behavior issues and eases parent stress. Parents of children born before 32 weeks who face behavior challenges might find this trial relevant. The trial requires English as the primary language spoken at home. As an unphased trial, this study offers parents a unique opportunity to contribute to research that could enhance parenting strategies for children born very preterm.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that parenting programs like I-InTERACT (I2P) are generally safe. Studies on similar programs for parents of premature babies indicate they can reduce stress and improve children's behavior without causing harm. In a small initial study, parents liked and accepted I2P, suggesting it is safe to use.

The I-InTERACT Microlearning Intervention (I2P-Micro) also appears promising. Although less information exists on this specific version, the initial trial showed that parents found it helpful. This suggests it is likely safe too, as it is based on the same principles as the original I2P program.

Overall, both I2P and I2P-Micro have demonstrated safety for parents of premature children, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I-InTERACT Parenting Interventions because they offer innovative support for families with preterm infants, focusing on enhancing parenting skills and interactions. Unlike traditional treatments that emphasize medical and developmental follow-up, these interventions use therapist-guided coaching to improve parent-infant interactions, potentially leading to better outcomes for the child's development and family well-being. The I-InTERACT Microlearning Intervention is particularly intriguing as it delivers bite-sized, easily accessible learning content, making it more adaptable to busy parents' schedules. By leveraging technology and personalized coaching, these interventions aim to empower parents in a way that is more proactive and engaging than current standard practices.

What evidence suggests that this trial's treatments could be effective for preterm birth?

Research has shown that the I-InTERACT Preterm (I2P) program, which participants in this trial may receive, can help parents manage behavior problems in children born very early. A small study found that this program improved parent-child interactions and reduced both children's behavior issues and parents' stress. Another treatment arm in this trial will test the I2P-Micro version, which offers short, focused learning sessions for easier use. This version is expected to provide similar benefits and might see more frequent use due to its convenient format. Both versions aim to equip parents with practical tools and support to better manage challenges. ^{1 2 4 6 7}

Who Is on the Research Team?

Shari Wade, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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.

English is not the primary language spoken in the home

Caregivers with a psychiatric hospitalization in the past year

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Internet Resource Group Experimental Treatment 1 Intervention

Control condition

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

Group III: I-InTERACT Microlearning Intervention (I2P-Micro) 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+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05282628

Study Details | NCT05282628 | I-InTERACT Preterm The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. trial.medpath.com trial.medpath.com/clinical-trial/1099c141a6003313/nct06767293-i-interact-preterm-parenting-trial

I-InTERACT Preterm Parenting | MedPath These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in ...

3. withpower.com withpower.com/trial/phase-problem-behavior-10-2024-ac5b2

Parenting Intervention for Preterm Birth (I2P-RCT Trial) These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/cch.13209

Feasibility and acceptability of an online parenting ... We examined the feasibility and acceptability of the I-InTERACT Preterm pilot study, an online parenting intervention for preterm children ages 3–8.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06767293/i-interact-preterm-parenting

I-InTERACT Preterm Parenting | Clinical Research Trial ... These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38100158/

Feasibility and acceptability of an online parenting ... - PubMed We examined the feasibility and acceptability of the I-InTERACT Preterm pilot study, an online parenting intervention for preterm children ages 3-8. Method: ...

7. researchgate.net researchgate.net/publication/397101651_Preliminary_efficacy_of_a_novel_online_parenting_skills_program_for_caregivers_of_preterm_children_with_behavioral_challenges

Preliminary efficacy of a novel online parenting skills ... Preliminary efficacy of a novel online parenting skills program for caregivers of preterm children with behavioral challenges.