Simulation-Based Education for Staff Managing Aggression and Externalizing Behaviors in Children With Autism Spectrum Disorder in the Hospital Setting: Pilot and Feasibility Study Protocol for a Cluster Randomized Controlled Trial
Authors: Mitchell Marijke Jane , Newall Fiona Helen , Sokol Jennifer , Williams Katrina Jane 
Published: May 2020

Background
Children with autism spectrum disorder (ASD) frequently demonstrate aggression and externalizing behaviors in the acute care hospital environment. Pediatric acute care nursing staff are often not trained in managing aggression and, in particular, lack confidence in preventing and managing externalizing behaviors in children with ASD. High-fidelity simulation exercises will be used in this study to provide deliberate practice for acute care pediatric nursing staff in the management of aggressive and externalizing behaviors.

Objective
The purpose of this study is to conduct a pilot and feasibility cluster randomized controlled trial (RCT) to evaluate the effectiveness of simulation-based education for staff in managing aggression and externalizing behaviors of children with ASD in the hospital setting.

Methods
This study has a mixed design, with between-group and within-participant comparisons to explore the acceptability and feasibility of delivering a large-scale cluster RCT. The trial process, including recruitment, completion rates, contamination, and completion of outcome measures, will be assessed and reported as percentages. This study will assess the acceptability of the simulation-based training format for two scenarios involving an adolescent with autism, with or without intellectual disability, who displays aggressive and externalizing behaviors and the resulting change in confidence in managing clinical aggression. Two pediatric wards of similar size and patient complexity will be selected to participate in the study; they will be randomized to receive either simulation-based education plus web-based educational materials or the web-based educational materials only. Change in confidence will be assessed using pre- and posttraining surveys for bedside nursing staff exposed to the training and the control group who will receive the web-based training materials. Knowledge retention 3 months posttraining, as well as continued confidence and exposure to clinical aggression, will be assessed via surveys. Changes in confidence and competence will be compared statistically with the chi-square test using before-and-after data to compare the proportion of those who have high confidence between the two arms at baseline and at follow-up. The simulation-based education will be recorded with trained assessors reviewing participants’ abilities to de-escalate aggressive behaviors using a validated tool. This data will be analyzed using mean values and SDs to understand the variation in performance of individuals who undertake the training. Data from each participating ward will be collected during each shift for the duration of the study to assess the number of aggressive incidents and successful de-escalation for patients with ASD. Total change in Code Grey activations will also be assessed, with both datasets analyzed using descriptive statistics.

Results
This study gained ethical approval from The Royal Children's Hospital Melbourne Human Research Ethics Committee (HREC) on November 1, 2019 (HREC reference number: 56684). Data collection was completed in February 2020. Data analysis is due to commence with results anticipated by August 2020.

Conclusions
We hypothesize that this study is feasible to be conducted as a cluster RCT and that simulation-based training will be acceptable for acute care pediatric nurses. We anticipate that the intervention ward will have increased confidence in managing clinical aggression in children with ASD immediately and up to 3 months posttraining.

Trial Registration
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000139976; http://www.ANZCTR.org.au/ACTRN12620000139976.aspx

International Registered Report Identifier (IRRID)
DERR1-10.2196/18105