ezPreemie study protocol: a randomised controlled factorial trial testing web-based parent training and coaching with parents of children born very preterm
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...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e063706.full |
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| author | M E Schoeny Sarah A Keim Michelle M Greene Julia Berteletti Mary Lauren Neel Kousiki Patra Shea Smoske Susan Breitenstein |
| author_facet | M E Schoeny Sarah A Keim Michelle M Greene Julia Berteletti Mary Lauren Neel Kousiki Patra Shea Smoske Susan Breitenstein |
| author_sort | M E Schoeny |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-bd775840899a4faaa18dd00396b0b893 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-bd775840899a4faaa18dd00396b0b8932025-02-01T14:05:14ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2022-063706ezPreemie study protocol: a randomised controlled factorial trial testing web-based parent training and coaching with parents of children born very pretermM E Schoeny0Sarah A Keim1Michelle M Greene2Julia Berteletti3Mary Lauren Neel4Kousiki Patra5Shea Smoske6Susan Breitenstein7College of Nursing, Rush University, Chicago, Illinois, USADepartment of Surgery, University of Kansas Medical Center, Kansas City, Missouri, USADepartment of Pediatrics, Rush University Medical Center, Chicago, Illinois, USAKlein Buendel Inc, Golden, Colorado, USADivision of Neonatology & Center for Perinatal Research, Nationwide Children`s Hospital, Columbus, Ohio, USADepartment of Pediatrics, Rush University Medical Center, Chicago, Illinois, USACollege of Nursing, The Ohio State University, Columbus, Ohio, USACollege of Nursing, The Ohio State University, Columbus, Ohio, USAIntroduction 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.https://bmjopen.bmj.com/content/12/6/e063706.full |
| spellingShingle | M E Schoeny Sarah A Keim Michelle M Greene Julia Berteletti Mary Lauren Neel Kousiki Patra Shea Smoske Susan Breitenstein ezPreemie study protocol: a randomised controlled factorial trial testing web-based parent training and coaching with parents of children born very preterm BMJ Open |
| title | ezPreemie study protocol: a randomised controlled factorial trial testing web-based parent training and coaching with parents of children born very preterm |
| title_full | ezPreemie study protocol: a randomised controlled factorial trial testing web-based parent training and coaching with parents of children born very preterm |
| title_fullStr | ezPreemie study protocol: a randomised controlled factorial trial testing web-based parent training and coaching with parents of children born very preterm |
| title_full_unstemmed | ezPreemie study protocol: a randomised controlled factorial trial testing web-based parent training and coaching with parents of children born very preterm |
| title_short | ezPreemie study protocol: a randomised controlled factorial trial testing web-based parent training and coaching with parents of children born very preterm |
| title_sort | ezpreemie study protocol a randomised controlled factorial trial testing web based parent training and coaching with parents of children born very preterm |
| url | https://bmjopen.bmj.com/content/12/6/e063706.full |
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