Feasibility study of an randomised controlled trial to investigate the whether a robot (KASPAR) can improve the social skills of children with an Autism Spectrum Disorder

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14156001

Enrollment

Registered

2017-02-23

Start date

2017-03-01

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Children, Primary sub-specialty: General Paediatrics

Interventions

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 The

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).

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026