Condition category
Mental and Behavioural Disorders
Date applied
20/02/2017
Date assigned
23/02/2017
Last edited
27/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Autism Spectrum Disorder (ASD) is a common disorder that affects the way that a person communicates and relates to others. It is a spectrum condition therefore the level of disability is spread across a wide range, from almost unnoticeable to completely debilitating. It is associated with difficulties in social communication/interaction and restricted, repetitive patterns of behaviour, interests or activities. ASD is a disabling condition, but early treatment increases the likelihood of improved long-term outcomes. However, parents frequently report waiting a long time for a diagnosis for their child and express feelings of dissatisfaction with the availability of interventions. One avenue of research has explored the use of Socially Assisted Robots (SARs) in supporting the social and emotional development of children with ASD. The SAR, KASPAR, has been used in studies aiming to improve the development of communication and social skills in children with ASD, particularly those of a young age, with promising results. Children play games with KASPAR, which aim to promote important skills for the development of social competence. Over a number of case studies, teachers, parents and carers have reported improvements in children’s behaviour, suggesting some benefits of robot mediated interventions. The aim of this study is to conduct a small study to find out if a full-scale trial comparing the social skills of children who interact with KASPAR and children who interact with a researcher only would be possible.

Who can participate?
Children newly diagnosed with ASD.

What does the study involve?
Participants randomly allocated to one of the groups. Children are given two 15 minute familiarisation sessions with the therapist and/or the robot which take place in a room with a one way mirror, so that parents can watch what it happening. Then, there are six therapy sessions lasting up to 20 minutes. During these sessions, the child plays “games” that include aspects of joint attention, turn taking and imitation. All the games include these skills, so the therapist can select the games according to the preference/ability of each child. Those children who are in the Therapist only group receive the program with KASPAR at the end of their involvement with the study. Parents are asked to complete questionnaires about their child’s behaviour and their own stress levels at the start of the study, soon after the program has finished (at 10 weeks) and 3 months after the program has finished (at 22 weeks).

What are the possible benefits and risks of participating?
Children and their parents are expected to benefit from receiving an intervention which is expected to improve their social communication skills. There are no notable risks involved with taking part.

Where is the study run from?
Peace Children’s Centre (UK)

When is the study starting and how long is it expected to run for?
December 2016 to November 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Karen Irvine
k.irvine2@herts.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karen Irvine

ORCID ID

http://orcid.org/0000-0003-4087-3802

Contact details

University of Hertfordshire
Health Research Building
College Lane
Hatfield
AL10 9AB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32090

Study information

Scientific title

Feasibility study of an randomised controlled trial to investigate the effectiveness of a humanoid robot to support social skills development in children with an Autism Spectrum Disorder

Acronym

KASPAR RCT

Study hypothesis

The aim of this study is to assess the feasibility of conducting a full-scale randomised controlled trial comparing the social skills of children who interact with KASPAR, a Socially Assisted Robot (SAR), and children who interact with a researcher only.

Ethics approval

South Cambridge REC, 18/11/2016, ref: 16/EE/0387

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Children, Primary sub-specialty: General Paediatrics; UKCRC code/ Disease: Mental Health/ Behavioural and emotional disorders with onset usually occurring in childhood and adolescence

Intervention

The child will be randomised, using a database, to either the KASPAR group or the Therapist only group (TOG). The child will then be randomised, using a database, to either the KASPAR group or the Therapist only group (TOG). The child will be allocated to a waiting list for a clinic, if there are no clinical appointments available.

There will be 20 children recruited into each group. The KASPAR group will consist of children who will have an intervention with KASPAR and the therapist. The Therapist Only Group (TOG) will consist of children who will play the same games, but with the therapist.

Sessions will run weekly. Children will be given two 15 minute familiarisation sessions with the therapist and/or the robot. These will take place in a room with a one way mirror, so that parents can watch what it happening. Then, there will be six therapy sessions lasting up to 20 minutes. During these sessions, the child will play “games” that include aspects of joint attention, turn taking and imitation. All the games include these skills, so the therapist can select the games according to the preference/ability of each child.

The follow up involves meeting with families and asking them to complete the same RCT outcome measures that were administered at baseline. Parents will be asked to complete questionnaires about their child’s behaviour and their own stress levels (the outcome measures) at three time points; before the intervention (at time 0), soon after the intervention has finished (at 10 weeks) and 3 months after the intervention has finished (at 22 weeks).

Intervention type

Other

Phase

Drug names

Primary outcome measures

Feasibility outcome measures:
1. Recruitment rate is assessed by recording the number of participants who consent to take part in the study (per month) during the 11 month recruitment period
2. Attrition rate is assessed by recording the percentage of participants in each arm of the study who fail to remain in the study until the last data collection point (i.e. 22 weeks after completing the intervention)
3. Outcome measure completion rate is assessed by recording the percentage of each of the questionnaires (RCT outcome measures) that are fully completed by study participants
4. Suitability of outcome measures for the main study is assessed through qualitative interviews with 50% of the study participants after the last data collection point (i.e. 22 weeks after completing the intervention)
5. Feasibility of collecting data for an economic analysis in a definitive trial is assessed using qualitative interviews with participants after the last data collection point (i.e. 22 weeks after completing the intervention). And by the percentage of questionnaires that are fully completed by study participants.
6. Acceptability of the intervention to parents and clinicians is assessed by qualitative interview with parents, children (where appropriate) and clinicians at the end of the study
7. Practicality of running the clinics where the intervention is delivered in the NHS setting is assessed during a qualitative interview with clinicians at the end of the study

Secondary outcome measures

1. Changes in behaviours associated with ASD are measured using the Social Communication Questionnaire (SCQ) and the Social Skills Improvement System (SSIS) at baseline 10 and 22 weeks
2. Parental stress is measured using the Parenting Stress Index 4 (PSI-4) at baseline 10 and 22 weeks
3. Quality of life of the child is measured with the Child Health Utility 9D (CHU-9D) at baseline 10 and 22 weeks
4. Health Economic benefits ree assessed using the Child and Adolescent Service Use Schedule (amended version) at baseline 10 and 22 weeks

Overall trial start date

01/12/2016

Overall trial end date

30/11/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female children aged 5-10 years
2. Diagnosis of an ASD confirmed by a clinician using ADOS and/or ADI
3. Able to understand or fluently speak English
4. IQ is above 70

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

Participant exclusion criteria

1. Currently in receipt of a privately-delivered social communication intervention (i.e. not part of NHS or education usual care)
2. The child is non-English speaking or if non-verbal, unable to understand English
3. Carer who is completing the questionnaire is unable to do so in English

Recruitment start date

01/03/2017

Recruitment end date

31/01/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Peace Children’s Centre
Peace Prospect
Watford
WD17 3EW
United Kingdom

Sponsor information

Organisation

Hertfordshire Community NHS Trust

Sponsor details

Howard Court
14 Tewin Road
Welwyn Garden City
AL7 1BW
United Kingdom
+44 (0)1707 388 133
john.omany@hct.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Organisation

University of Hertfordshire

Sponsor details

College Lane
Hatfield
AL10 9AB
United Kingdom
+44 (0)1727 284000
j.m.senior@herts.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Study protocol currently being prepared for submission. Other publications will be published in high-impact peer reviewed open access journals during 2020.

IPD sharing plan
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28645986

Publication citations

Additional files

Editorial Notes

27/06/2017: Publication reference added.