Using a Respectful Approach to Child-centred Healthcare (ReACH) in a paediatric clinical trial: A feasibility study

Abstract

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.

Fig 1. Flow diagram for the Milky Way Study, detailing study participant recruitment, randomisation and retention pre- and post-intervention (intervention duration = three months).

Fig 2. ReACH resource showing the sequence of tests at a trial clinic visit, with detachable photographs able to serve as a visual guide both to test procedures and to track progress over the visit: From left to right photographs present represent assessment of weight, waist measurement and BodPod body composition analysis (top row); blood pressure, strength, blood test and ‘graduation’ certificate awarded after all clinics completed (lower row, cut off).

(Written informed consent has been provided by the legal guardian on behalf of the individual in these photographs (as outlined in PLOS consent form) to publish these case details. Fig 2 has been reprinted from [22] under a CC BY license, with permission from MDPI, original copyright 2018).

Fig 3. Excerpts from the Milky Way Study Child Information Leaflet: Upper: Astronaut training in the Bod Pod.

The Bod Pod uses non-invasive air-displacement to measure body composition (lean mass and fat mass). Participants need to sit inside during testing, and there is a paediatric seat for children under six years of age. Lower: Having blood samples taken. (Pages reproduced from the Milky Way Study Child Information Leaflet. Fig 3 was previously published as two separate figures, and has been reprinted from [22] under a CC BY license, with permission from MDPI, original copyright 2018).

Fig 4. Child Comfort Evaluation Tool for self-evaluation of comfort and satisfaction with Milky Way Study clinic sessions and assessments.

This figure is similar but not identical to the original image used in the study and is provided for illustrative purposes only. (Written informed consent has been provided by the legal guardian on behalf of the individual in these photographs (as outlined in PLOS consent form) to publish these case details).