Inclusive protocols to facilitate the collection of biological samples in children with neurodevelopmental disorders

Objectives Most conventional study protocols are designed for typically developing children, resulting in exclusion of children with neurodevelopmental disorders (NDDs) in medical research. Children with NDDs who have behaviours of concern (BoC) encounter additional barriers to participation. To address this gap, we designed and evaluated an inclusive protocol for biological sample collection in children with NDDs across a range of developmental profiles, including those with BoC. Methods Inclusive protocols for stool and breath collection were developed through use of existing standard protocols, a comprehensive literature review, clinical expertise, lived experience, and iterative feedback from participating families. Biological samples were collected at four time-points over a 9-month period from children with NDDs and BoC and their siblings who were either typically developing (TD) or had NDDs without BoC. Anonymous end-of-study surveys were conducted to report participant feedback and reflections. Results Adaptations implemented in the inclusive protocols included flexible scheduling, reduced travel requirements, alternative collection methods, stepwise demonstrations, visual aids, sensory tools, and social stories. All 18 participants completed stool collection (NDD-BoC n = 9/9; TD-Sibling n = 5/5; NDD-Sibling n = 4/4), and the majority (n = 17/18) completed breath collection (NDD-BoC n = 8/9; TD-Sibling n = 5/5; NDD-Sibling n = 4/4). Survey responses highlighted individualized support and flexibility as the primary facilitators of successful participation. Conclusion The inclusive protocols developed in this study enabled high completion of biologic sample collection among children with NDDs, including those with BoC. These approaches allow for participation and improve the representativeness of research samples, enabling findings that reflect real-world clinical populations.