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.

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