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Published on: January 12, 2018
ezPreemie study protocol: a randomised controlled factorial trial testing web-based parent training and coaching with
Michelle M Greene1, M E Schoeny2, Julia Berteletti3
1Department of Pediatrics, Rush University Medical Center, Chicago, Illinois, USA.
Insights
This study tests a new behavioral parent training program, ezParent, with or without coaching, for very preterm children. It aims to improve behavior problems in toddlers born before 32 weeks gestation.
Area of Science:
- Pediatrics
- Developmental Psychology
- Neonatal Care
Background:
- Children born very preterm (VPT) exhibit higher rates of behavioral problems compared to term-born peers.
- Behavioral parent training (BPT) is effective for childhood behavior issues, but accessible interventions for VPT families are limited.
Purpose of the Study:
- To describe a randomized controlled trial protocol evaluating the ezParent BPT intervention and weekly coaching calls for families with VPT toddlers.
- To assess the independent and combined effects of ezParent and coaching on parent and child outcomes.
Main Methods:
- A 2x2 factorial randomized design with 220 parents of VPT children (20-30 months corrected age).
- Participants are randomized into four groups: ezParent, ezParent + coach, Active Control, or Active Control + coach.
- Data collected at baseline and 3, 6, 12 months post-randomization using intention-to-treat analysis.
Main Results:
- This section describes the study protocol and methodology.
- The primary outcomes are parent and child behavior, with data collected over 12 months.
- The study is registered under NCT05217615.
Conclusions:
- The trial will provide data on the efficacy of ezParent and coaching for VPT toddlers.
- Findings will inform the development of accessible BPT interventions for this vulnerable population.
- Results will be disseminated through publications and presentations.
Introduction:
Children born very preterm (VPT; gestational age <32 weeks) are twice as likely to demonstrate behaviour problems such as aggression, non-compliance, temper tantrums and irritability compared with their term-born peers. While behavioural parent training (BPT), also referred to as behaviour therapy is a gold standard for prevention and treatment of childhood problem behaviours, there are limited accessible and effective BPT interventions for families with children born VPT. The purpose of this paper is to describe a multicentre, randomised 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 VPT.
Methods And Analysis:
The study employs a 2×2 factorial randomised design. Parents (n=220) of children aged 20-30 months corrected age who were born VPT (<32 weeks) will be recruited from two large metropolitan Neonatal Intensive Care Units follow-up clinics and randomised to one of four conditions: (1) ezParent (2) ezParent +coach, (3) Active control or (4) Active Control +coach. Data on parenting and child behaviour outcomes will be obtained from all participants at baseline and 3, 6 and 12 months postbaseline. All analyses will use an intention-to-treat approach, independent of their actual dose of each intervention.
Ethics And Dissemination:
The study protocol has been approved by The Ohio State University Institutional Review Board (IRB) using a single IRB. Study results will be disseminated through presentations at regional and national conferences, publications in peer-reviewed journals, and sharing research reports with participating families and recruiting sites.
Trial Registration Number:
NCT05217615.
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