Autistic children and adults who are non-verbal/minimally verbal or have an intellectual disability have often been excluded from Autism Spectrum Disorder research. Historical, practical and theoretical reasons for this exclusion continue to deter some researchers from work with this underserved population. We discuss why these reasons are neither convincing nor ethical, and provide strategies for dealing with practical issues. As part of a randomised controlled trial of an intervention for children with profound autism, we reflected as a multi-disciplinary team on what we had learnt from these children, their families and each other. We provide 10 strategies to overcome what appeared initially to be barriers to collecting data with this population. These hurdles and our solutions are organised by theme: interacting physically with children, how to play and test, navigating difficult behaviours, selecting suitable outcome measures, relating with parents, managing siblings, involving stakeholders, timing interactions, the clinician’s role in managing expectations, and recruitment. The aim of this article is to provide researchers with the tools to feel motivated to conduct research with children with profound autism and their families, a difficult but worthwhile endeavour. Many of these lessons also apply to conducting research with non-autistic children with intellectual disabilities. Lay abstract Autistic children who speak few or no words or who have an intellectual disability are the most in need of new understandings and treatments, but the most often left out of the research that can bring these benefits. Researchers perceive difficulties around compliance with instructions, testing, challenging behaviours and family stress. Although research with these children can indeed be difficult, their continuing exclusion is unethical and unacceptable. Drawing on our experiences testing a possible treatment for children with profound autism, we provide 10 practical guidelines related to (1) interacting physically, (2) combining play and testing, (3) responding to challenging behaviour, (4) finding suitable tests, (5) relationships with parents, (6) relationships with siblings, (7) involving stakeholders, (8) planning the testing times, (9) the role of the clinical supervisor and (10) recruiting and retaining participants. We hope that these guidelines will prepare and embolden other research teams to work with profoundly autistic children, ending their historical exclusion from research. These guidelines also could be useful for conducting research with children with intellectual disabilities.

Background: Point OutWords is a caregiver-delivered, iPad-assisted intervention for non-verbal or minimally verbal children with autism. It aims to develop prerequisite skills for communication such as manual and oral motor skills, sequencing, and symbolic representation. This feasibility trial aims to determine the viability of evaluating the clinical efficacy of Point OutWords. Methodology: We aim to recruit 46 non-verbal or minimally verbal children with autism and their families, approximately 23 per arm. Children in the intervention group will use Point OutWords for half an hour, five times a week, for 8 weeks. Children in the control group will have equal caregiver-led contact time with the iPad using a selection of control apps (e.g. sensory apps, drawing apps). Communication, motor, and daily living skills are assessed at baseline and post-intervention. Parents will keep diaries during the intervention period and will take part in focus groups when the intervention is completed. Discussion: Point OutWords was developed in collaboration with children with autism and their caregivers, to provide an intervention for a subgroup of autism that has been historically underserved. As autism is a heterogeneous condition, it is unlikely that one style of intervention will address all aspects of its symptomatology; the motor skills approach of Point OutWords can complement other therapies that address core autistic symptoms of social cognition and communication more directly. The current feasibility trial can inform the selection of outcome measures and design for future full-scale randomised controlled trials of Point OutWords and of other early interventions in autism. Trial registration: ISRCTN, ISRCTN12808402. Prospectively registered on 12 March 2019.

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