Study protocol for a pragmatic parallel-group randomised controlled trial to evaluate the effectiveness of coaching with an online intervention, compared with the online intervention alone, for families of children who have experienced developmental regression
BMJ open, Vol.16(6), pp.1-13
10/06/2026
: 42270104
1
Introduction: Developmental regression is when children lose one or more skills they have established. Families caring for these children need timely recognition to assist diagnosis and tailored interventions. Families also need support to develop practical skills for caregiving and strategies to promote family well-being and community participation. Given the high caring demands, flexibly delivered approaches are needed to accommodate family routines. Online delivery of health-related interventions that provide coaching, information, or both has been found to be a feasible and effective option for families. Family Focus is a new family-centred online programme, co-designed with parents and family advocates, clinicians, and researchers to support and empower primary carers.
Methods and analysis: This study is a prospective, pragmatic randomised controlled trial comparing the effectiveness of online parent coaching plus Family Focus (Coaching+FF) to Family Focus alone (FF) for primary carers of children experiencing developmental regression. A sample of 56 families will be randomised in a 1:1 ratio. Outcomes are assessed at baseline, post-intervention and 12-month post-randomisation. The primary outcome is parental stress symptoms at post-intervention. Secondary outcomes include parental depressive and anxiety symptoms, parental engagement in health-promoting activities, family empowerment, family quality of life and child global health outcomes. The study will also examine the uptake and acceptability of specific coaching and FF components and explore the facilitators and barriers to their delivery and implementation.
Ethics and dissemination: Ethics approvals were obtained from the participating organisations (Monash Health HREC/107806). Informed consent is obtained from parents/guardians of children prior to study enrolment. Study findings will be disseminated through peer-reviewed publications, conference presentations and lived experience agencies.
trial Registration Number: ISRCTN25513446.
- Study protocol for a pragmatic parallel-group randomised controlled trial to evaluate the effectiveness of coaching with an online intervention, compared with the online intervention alone, for families of children who have experienced developmental regression
- Wan Hua Sim - Monash UniversityMonica Leo - Monash Children’s HospitalHelen M Bourke-Taylor - Monash UniversityCharmaine Bernie - Monash UniversityAmanda Brignell - Monash UniversityAlexandra Ure - Monash UniversityKirsten Furley - Monash UniversityAdele Maree FaheyAnoo Bhopti - Monash UniversitySorcha Odgers - Monash UniversityLeah Picking - Monash UniversityJue Xie - Monash UniversityLing Wu - Monash UniversityMarie B H Yap - Monash UniversityKatrina Williams - Monash University
- BMJ open, Vol.16(6), pp.1-13
- BMJ Group; LONDON
- This project was funded by a Medical Research Future Fund grant from the Australian Government Department of Health and Aged Care (APP2017650).
- 991013386450102368
- © Author(s) (or their employer(s)) 2026.
- Faculty of Health
- English
- Journal article