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Paediatrics
Protocol
Feasibility study of a randomised controlled trial to investigate the effectiveness of using a humanoid robot to improve the social skills of children with autism spectrum disorder (Kaspar RCT): a study protocol
  1. Silvana E Mengoni1,
  2. Karen Irvine1,
  3. Deepshikha Thakur2,
  4. Garry Barton3,
  5. Kerstin Dautenhahn4,
  6. Karen Guldberg5,
  7. Ben Robins4,
  8. David Wellsted1,
  9. Shivani Sharma1
  1. 1 Centre for Health Services and Clinical Research, Department of Psychology and Sport Sciences, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK
  2. 2 Hertfordshire Community NHS Trust, Welwyn Garden, Hertfordshire, UK
  3. 3 Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, UK
  4. 4 School of Computer Science, University of Hertfordshire, Hatfield, UK
  5. 5 Autism Centre for Education and Research, School of Education, University of Birmingham, Birmingham, UK
  1. Correspondence to Dr Shivani Sharma; s.3.sharma{at}herts.ac.uk

Abstract

Introduction Interventions using robot-assisted therapy may be beneficial for the social skills development of children with autism spectrum disorder (ASD); however, randomised controlled trials (RCTs) are lacking. The present research aims to assess the feasibility of conducting an RCT evaluating the effectiveness of a social skills intervention using Kinesics and Synchronisation in Personal Assistant Robotics (Kaspar) with children with ASD.

Methods and analysis Forty children will be recruited. Inclusion criteria are the following: aged 5–10 years, confirmed ASD diagnosis, IQ over 70, English-language comprehension, a carer who can complete questionnaires in English and no current participation in a private social communication intervention. Children will be randomised to receive an intervention with a therapist and Kaspar, or with the therapist only. They will receive two familiarisation sessions and six treatment sessions for 8 weeks. They will be assessed at baseline, and at 10 and 22 weeks after baseline. The primary outcome of this study is to evaluate whether the predetermined feasibility criteria for a full-scale trial are met. The potential primary outcome measures for a full-scale trial are the Social Communication Questionnaire and the Social Skills Improvement System. We will conduct a preliminary economic analysis. After the study has ended, a sample of 20 participants and their families will be invited to participate in semistructured interviews to explore the feasibility and acceptability of the study’s methods and intervention.

Ethics and dissemination Parents/carers will provide informed consent, and children will give assent, where appropriate. Care will be taken to avoid pressure or coercion to participate. Aftercare is available from the recruiting NHS Trust, and a phased withdrawal protocol will be followed if children become excessively attached to the robot. The results of the study will be disseminated to academic audiences and non-academic stakeholders, for example, families of children with ASD, support groups, clinicians and charities.

Trial registration number ISRCTN registry (ISRCTN14156001); Pre-results.

  • community child health
  • developmental neurology & neurodisability
  • child & adolescent psychiatry

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2017-017376

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    Footnotes

    • Contributors SS conceived the study. SS, KI, DT and DW designed the study. KI and SS wrote the first draft of the funding application and along with DT, GB, KG, BR and DW were the funding applicants. SEM prepared the study documents and coordinated the HRA and ethics applications. SEM drafted the first version of the protocol manuscript for publication, with input from SS and KI. All authors approved the final protocol.

    • Funding This article presents independent research funded by the National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) (grant reference: PB-PG-0215-36122).

    • Disclaimer The views expressed are those of the author(s) and not necessarily those of theNHS, the NIHR or the Department of Health.

    • Competing interests The University of Hertfordshire (employing organisation of SM, KI, KD, BR, DW and SS) has made a patent application in relation to KASPAR.

    • Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.

    • Ethics approval Cambridge South Research Ethics Committee.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

    • Correction notice This paper has been amended since it was published Online First. Owing to a scripting error, some of the publisher names in the references were replaced with 'BMJ Publishing Group'. This only affected the full text version, not the PDF. We have since corrected these errors and the correct publishers have been inserted into the references.