Point OutWords: protocol for a feasibility randomised controlled trial of a motor skills intervention to promote communicative development in non-verbal children with autism

Abstract

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.

Keywords: Autism spectrum disorder; Communication; Feasibility; Language; Minimally verbal; Motor; Non-verbal; Randomised controlled trial; iPad.

Fig. 1

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure with timeline for recruitment, assessments, and interventions. Schedule of assessments: MSEL Mullen Scales of Early Learning, BOSCC Brief Observation of Social Communication Change, DCMA Dyadic Communication Measure for Autism, BPVS-3 British Picture Vocabulary Scale, SRS-2 Social Responsiveness Scale, VMPAC Verbal Motor Production Assessment for Children, PSI-4 Parenting Stress Index, VABS-2 Vineland Adaptive Behavior Scales, FQoLS Family Quality of Life Scale, AIM Autism Impact Measure. Blue lines indicate the intervention group and black lines indicate the control group