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Using a Respectful Approach to Child-centred Healthcare (ReACH) in a paediatric clinical trial: A feasibility study
Analise Nicholl1, Kate Evelegh1, Kane Evan Deering1
1School of Medical and Health Sciences, Edith Cowan University, Joondalup, Perth, Western Australia, Australia.
Insights
The Respectful Approach to Child-centred Healthcare (ReACH) improved children's compliance in clinical trial assessments. This child-centred method was found feasible and acceptable to children and parents, enhancing their study experience.
Area of Science:
- Pediatric ethics
- Clinical trial methodology
- Child psychology
Background:
- Growing need for ethical, respectful research and healthcare protocols in pediatrics.
- Development and refinement of the 'Respectful Approach to Child-centred Healthcare' (ReACH) framework.
- ReACH aims to ensure respectful participant interactions within clinical trials.
Purpose of the Study:
- To evaluate the acceptability and effectiveness of the ReACH approach in a clinical trial involving healthy 4-6-year-old children.
- To determine if ReACH facilitates compliance with common healthcare assessments.
- To gather feedback from children and parents on their experience with the ReACH-based protocol.
Main Methods:
- Mixed-methods evaluation of ReACH-based assessments in a clinical trial.
- Inclusion of 49 healthy children (46.9% female, mean age 5.24 years) and their parents.
- Data collection through customized 5-point Likert scales, qualitative feedback, and researcher adherence evaluation.
Main Results:
- High compliance rates observed: 95% for body composition, 89% for blood pressure, and 92% (baseline) / 87% (post-intervention) for blood draws.
- Positive association between adherence to ReACH principles and child compliance, particularly for BodPod and blood tests.
- High participant satisfaction: 91.7% (baseline) and 100% (post-intervention) of parents satisfied with the study; positive qualitative feedback on the experience.
Conclusions:
- Adherence to the ReACH approach is linked to high child compliance in healthcare assessments.
- The ReACH method appears feasible and acceptable for pediatric clinical trials.
- Child-centred methods enhance participant satisfaction and the overall research experience.
Background:
There is a growing momentum in paediatric ethics to develop respectful research and healthcare protocols. We developed, tested and refined our 'Respectful Approach to Child-centred Healthcare' (ReACH), to underpin respectful participant interactions in a clinical trial.
Objective:
To determine whether a ReACH-based approach is acceptable to children and parents, and effective in obtaining compliance with common healthcare assessments in a clinical trial of healthy 4-6-year-old children.
Methods:
ReACH-based child assessments were evaluated at two baseline clinics and one post-intervention, using mixed methods. Children (n = 49; 46.9% female; mean age = 5.24±0.88 years at baseline) and their parents provided independent evaluation, via customised 5-point Likert scales and qualitative feedback. A dedicated child researcher evaluated adherence to the study ReACH principles.
Results:
Children achieved compliance rates of 95% for body composition (BodPod) assessments; 89% for blood pressure measurements, and 92% (baseline) and 87% (post-intervention) for blood draws. Adherence to ReACH principles during clinic visits was positively associated with child compliance, significantly for baseline BodPod (p = 0.002) and blood test (p = 0.009) clinics. Satisfaction with BodPod protocols was positively associated with compliance, for children at baseline (p = 0.029) and for parents post-intervention (p <0.001). Parents rated the study itself very highly, with 91.7% satisfied at baseline and 100% post-intervention. Qualitative feedback reflected an enjoyable study experience for both parents and children.
Conclusions:
Adherence to our emerging ReACH approach was associated with high child compliance rates for common healthcare assessments, although no causality can be inferred at this preliminary stage of development. Participants expressed satisfaction with all aspects of the study. Our use of child-centred methods throughout a research intervention appears feasible and acceptable to children and their parents.
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