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EZPreemie Study Protocol

EZPreemie Study Protocol

A research team from The Ohio State University, Rush University, Nationwide Children’s Hospital, and Klein Buendel has published a paper describing a 5-year research project to develop and evaluate a technology-based, widely accessible, and effective form of behavioral parent training (BPT) delivery to address the unmet and unique needs of parents of very preterm children.

As presented in the paper published in BMJ Open, children born very preterm (gestational age <32 weeks) are twice as likely to demonstrate behavior problems such as aggression, non-compliance, temper tantrums and irritability compared with their term-born peers. While BPT is a gold standard for prevention and treatment of childhood problem behaviors, there are limited accessible and effective BPT interventions for families with children born very preterm. The paper describes a multi-center, randomized controlled protocol for a factorial design trial evaluating the independent and combined effects of the ezParent BPT intervention plus brief, weekly coaching calls on parent and child outcomes for families with toddlers born very preterm.

The BMJ Open paper details the study design, aims, intervention, measures, analysis plans, and procedures of the study which will employ a 2×2 factorial randomized design. Parents (n=220) of children aged 20–30 months corrected age who were born very preterm (<32 weeks) will be recruited from two large metropolitan Neonatal Intensive Care Unit follow-up clinics and randomized to one of four conditions: (1) ezParent (2) ezParent + coach, (3) active control or (4) active control + coach. A web-based app will provide behavioral training through brief videos, interactivity, reflection questions, and assessments. Data on parenting and child behavior outcomes will be obtained from all participants at baseline and 3, 6 and 12 months for program evaluation.

This research is being led by Dr. Susan Breitenstein from The Ohio State University (OSU) and Dr. Michelle Greene of Rush University (Multiple Principal Investigators). It is funded by a grant from The Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institute of Health (HD104072). Additional co-authors on this publication include Dr. Michael Schoeny and Dr. Kousiki Patra from Rush University; Dr. Sarah Keim from Nationwide Children’s Hospital and OSU; Dr. Mary Lauren Neel from Nationwide Children’s Hospital; Ms. Shea Smoske from OSU; and Ms. Julia Berteletti from Klein Buendel.

ezPreemie Project

ezPreemie Project

Today, 80-90% of very preterm infants survive. However, preterm birth alters the development of the prefrontal cortex, the brain region heavily involved in behavior regulation and inhibition. This places children born very preterm at high risk for developmental delays and behavioral problems.

Early prevention and intervention can interrupt the development of problem behaviors, reduce active problem behaviors and improve functioning for children and families. Behavioral parent training (BPT) is a gold standard for prevention and treatment of child behavior problems. BPT teaches child management skills and positive parenting strategies. Little is known about the use and effects of BPT programs for former very preterm infants with their unique medical, developmental, and psychological risk profiles.

A research team from Ohio State University, Rush University, Nationwide Children’s Hospital, and Klein Buendel is launching a 5-year research project to develop and evaluate a technology-based, widely accessible, and effective form of BPT delivery to address the unmet and unique needs of parents of very preterm children. The app will be tested alone and in combination with specialized coaching. The project is called “Parent Training for Parents of Toddlers Born Very Premature.” It is being led by Dr. Susie Breitenstein from Ohio State University (OSU) and Dr. Michele Greene from Rush University (Multiple Principal Investigators). The project is funded by The Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health (HD104072).

The research project will design and develop a web-based app, similar to one developed previously by Dr. Breitenstein and her team, called ezParent. ezParent was designed for parents of children ages 2-6 years. It provides behavioral training through brief videos, interactivity, reflection questions, and assessments to parents of young children. The new iteration of ezParent, ezPreemie, will assess the independent and combined effects of ezParent and coaching calls on parent and child outcomes in families with very preterm infants.

Dr. Breitenstein, PhD, RN, FNAP, FAAN, is an Associate Professor, Assistant Dean for Research and Innovation, and Senior Director, Community Outreach and Engagement & CHW Training Program in the OSU College of Nursing. Dr. Michelle Greene is an Associate Professor and Director of the Psychology Section in the Department of Pediatrics at Rush Medical College. Research Co-investigators include Dr. Michael Schoeny and Dr. Kousiki Patra from Rush University, Dr. Sarah Keim and Dr. Mary Lauren Neel from Nationwide Children’s Hospital, and Ms. Julia Berteletti from Klein Buendel. The ezPreemie app will be engineered by Klein Buendel’s Creative Team.