Parenting Intervention for Preterm Birth
(I2P-RCT Trial)
Recruiting in Palo Alto (17 mi)
Overseen byShari Wade, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's Hospital Medical Center, Cincinnati
Disqualifiers: Under 18, Unstable caregiving, Psychiatric hospitalization, others
No Placebo Group
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.
12345Is 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.
24567How 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.
24567Eligibility 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
+1 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Internet Resource GroupExperimental Treatment1 Intervention
Control condition
Group II: I-InTERACT Intervention (I2P) with regularly scheduled therapist coachingActive Control1 Intervention
Group III: I-InTERACT Microlearning Intervention (I2P-Micro) with regularly scheduled therapist coachingActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cincinnati Children's Hospital Medical CenterCincinnati, OH
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Who Is Running the Clinical Trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
References
Are parenting interventions effective in improving the relationship between mothers and their preterm infants? [2022]To systematically review the efficacy of parenting interventions in improving the quality of the relationship between mothers and preterm infants.
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]There is a dearth of knowledge about the effects of early interaction-based interventions on parenting and infant communication skills in moderately and late preterm infants.
Parenting Interventions Targeting Behavior for Children Born Preterm or Low Birth Weight: A Systematic Review. [2023]To systematically review and summarize the outcomes of parenting interventions designed to improve child and/or parenting behavior for children born preterm and/or low birth weight (LBW).
Effects on Parental Stress of Early Home-Based CareToy Intervention in Low-Risk Preterm Infants. [2020]Parenting a preterm infant is more challenging than a full-term one. Parent involvement in early intervention programs seems to have positive psychosocial effects on both the child and parent. CareToy is an innovative smart system that provides an intensive individualized home-based family-centred EI in preterm infants between 3 and 9 age-corrected months. A RCT study, preceded by a pilot study, has been recently carried out to evaluate the effects of CareToy intervention on neurodevelopmental outcomes with respect to Standard Care. This study aims at evaluating the effects of CareToy early intervention on parenting stress in preterm infants. Parents (mother and father) of a subgroup of infants enrolled in the RCT filled out a self-report questionnaire on parenting stress (Parenting Stress Index-Short Form (PSI-SF)) before (T0) and after (T1) the CareToy or Standard Care period (4 weeks), according to the allocation of their preterm infant. For twins, an individual questionnaire for each one was filled out. Results obtained from mothers and fathers were separately analysed with nonparametric tests. 44 mothers and 44 fathers of 44 infants (24 CareToy/20 Standard Care) filled out the PSI-SF at T0 and at T1. CareToy intervention was mainly managed by mothers. A significant (p < 0.05) reduction in Parental Distress subscale in the CareToy group versus Standard Care was found in the mothers. No differences were found among the fathers. CareToy training seems to be effective in reducing parental distress in mothers, who spent more time on CareToy intervention. These findings confirm the importance of parental involvement in early intervention programs. This trial is registered with Clinical Trial.gov NCT01990183.
Efficacy of preventative parenting interventions for parents of preterm infants on later child behavior: a systematic review and meta-analysis. [2018]The aim of this systematic review was to determine the efficacy of parenting interventions for parents of preterm infants to improve child behavior. Randomized controlled trials (RCTs) of parenting interventions for parents of preterm infants were included. Searchers were conducted of PubMed from 1951 to April 2013, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) from 1982 to April 2013, Scopus from 1966 to April 2013, PsycINFO from 1840 to April 2013, the Web of Science, and the Cochrane Library. Twelve RCTs were identified that assessed child behavior. Of these studies, only data from three were able to be pooled for meta-analysis: the Infant Health and Development Program (IHDP) at 3 years, the Mother-Infant Transaction Program (modified; MITP-M) at 5 years, and the Victorian Infant Brain Studies (VIBeS Plus) at 4 years. Outcome from this analysis revealed a small, but significant, effect on child behavior favoring the intervention (95% CI: 0.08-0.32; p = .001). There is evidence that preterm parenting interventions can improve child behavior. Streamlined interventions such as MITP-M and VIBeS Plus that have a strong focus on the mother-infant relationship may have greatest potential.
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]Improved neonatal care has resulted in increased survival rates among infants born after only 22 gestational weeks, but extremely preterm children still have an increased risk of neurodevelopmental delays, learning disabilities and reduced cognitive capacity, particularly executive function deficits. Parent-child interaction and parental mental health are associated with infant development, regardless of preterm birth. There is a need for further early interventions directed towards extremely preterm (EPT) children as well as their parents. The purpose of this paper is to describe the Stockholm Preterm Interaction-Based Intervention (SPIBI), the arrangements of the SPIBI trial and the chosen outcome measurements.
An Early Collaborative Intervention Focusing on Parent-Infant Interaction in the Neonatal Period. A Descriptive Study of the Developmental Framework. [2021]Moderate to late preterm infants are at risk of developing problems later in life. To support attachment and infants' development, high quality parent-infant interaction is important. Parent-infant interaction is known to improve through intervention programs but since no such intervention program is addressed directly to moderate to late preterm infants, a tailor-made intervention was developed. The aim was to describe the rationale, development, framework and practical provision of a new early collaborative intervention program. This study has a descriptive design and the intervention is described using the Template for Intervention Description and Replication. During an intervention-session, the preterm infant's cues are made visible to the parents as they perform an everyday care-taking procedure. Instant feedback is delivered to give the parents the opportunity to notice, interpret and respond to cues immediately. The infant's response to the parent's action is discussed in a dialogue to instantly guide parents´ awareness of the preterm infant's subtle cues. This study describes a new early collaborative intervention, developed to support interaction between parents and their moderate to late preterm infants starting in the neonatal intensive care unit. Clinical studies evaluating parental experiences as well as the effects of the early intervention are ongoing, ClinicalTrials.gov NCT02034617.