Clinical trial NCT03323931: The Efficacy of Robot-enhanced Therapy for Children With Autism Spectrum Disorders
Official title: DREAM Project Trial: Testing the Efficacy of Robot-enhanced Therapy for Children With Autism Spectrum Disorders in a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorders Spectrum
Keywords: autism spectrum disorder
robot-enhanced intervention
imitation
joint attention
turn-taking
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: University of Skövde
name: Vrije Universiteit Brussel
name: University of Plymouth
name: University of Portsmouth
name: De Montfort University
name: SoftBank Robotics
First posted: 2017-10-27
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Random allocation to one of two intervention conditions: (1) standard therapy, derived from applied behavior analysis (ABA) and (2) a robot-enhanced intervention in which the same intervention is delivered by a semi-autonomous robotic mediator agent (the robot acts as a mediator while the therapist is supervising the session).
Primary purpose: TREATMENT

Brief summary: This trial will test the efficacy of robot-enhanced interventions for developing social skills in children with Autism Spectrum Disorders (ASD). The study will compare, in an equivalence design, an innovative intervention delivered by a semi-autonomous robotic agent with standard behavioral intervention. The target group is children between 3 and 6 years old which will be randomly allocated to one of the two treatments. Each treatment will be delivered over 8 bi-weekly sessions of 45 minutes each.

Detailed description: Autism Spectrum Disorders (ASD) is characterized by a pattern of persistent deficits in communication and abnormal behaviors (i.e., repetitive and restrictive). Previous research has shown promising results for the use of social robots to develop social skills in ASD children. However, most of the research is based on case studies and single case experiments. Rigorous clinical data comparing robot--enhanced therapy with standard therapy is needed to establish the efficacy of this innovative intervention. The present study is an equivalence randomised clinical trial which plans to include children with a diagnosis of ASD between 3 to 6 years old. Eligible children are randomly allocated in one of two groups: (1) standard therapy, derived from applied behavior analysis (ABA) and (2) a robot--enhanced intervention in which the same treatment is delivered by a semi--autonomous robotic mediator agent (the robot acts as a mediator while the therapist is supervising the session). Both interventions are delivered over 8 bi-weekly sessions of about 45 minutes each. The present study will provide some of the first rigorous data regarding the efficacy of robot--enhanced therapy delivered by an intelligent robotic agent which require less direct input from an operator to deliver the intervention, as compared to previous research. If the results demonstrate the equivalence of the two interventions, this could open the door for the dissemination of evidence--based interventions for ASD children through the use of robotic agents.

Eligibility criteria: Inclusion Criteria:

* to be diagnosed using DSM-V criteria by a psychiatrist;
* the diagnostic is confirmed by the Autism Diagnostic Observation Scale (ADOS; scores are in the clinical range).

Primary outcomes:
measure: Changes in Imitation skills ratings
timeFrame: The measurement of Imitation skills will be conducted before the intervention and after the intervention (after 8 sessions / after 4 weeks). The outcome will be represented by change scores on this measure.
measure: Changes in Joint-attention skills ratings
timeFrame: The measurement of Joint-attention skills will be conducted before the intervention and after the intervention (after 8 sessions / after 4 weeks). The outcome will be represented by change scores on this measure.
measure: Changes in Turn-taking skills ratings
timeFrame: The measurement of Turn-taking skills will be conducted before the intervention and after the intervention (after 8 sessions / after 4 weeks). The outcome will be represented by change scores on this measure.
Secondary outcomes:
measure: Changes in Engagement in the task ratings
timeFrame: This measure will be assessed 10 times: once, one week before the intervention; 8 times in 4 weeks (twice every week) during the intervention; once, one week, after the intervention.
measure: Changes in Verbal utterances ratings
timeFrame: This measure will be assessed 10 times: once, one week before the intervention; 8 times in 4 weeks (twice every week) during the intervention; once, one week, after the intervention.
measure: Changes in Performance in sharing information task
timeFrame: This measure will be assessed 10 times: once, one week before the intervention; 8 times in 4 weeks (twice every week) during the intervention; once, one week, after the intervention.
measure: Changes in Performance in sorting in categories task
timeFrame: This measure will be assessed 10 times: once, one week before the intervention; 8 times in 4 weeks (twice every week) during the intervention; once, one week, after the intervention.
measure: Performance in continuing repetitive patterns task
timeFrame: This measure will be assessed 10 times: once, one week before the intervention; 8 times in 4 weeks (twice every week) during the intervention; once, one week, after the intervention.
Other outcomes:
measure: Autism Diagnostic Observation Schedule (ADOS)
timeFrame: The test will be applied twice: one week before the intervention and one week after the intervention.
measure: Social Communication Questionnaire (SCQ)
timeFrame: The test will be applied twice: one week before the intervention and one week after the intervention.
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University Psychological Clinic
Study officials:
References:
citation: Lord, C, Rutter, M, DiLavore, PC, Risi, Sl. Autism diagnostic observation schedule: ADOS manual. Los Angeles: Western Psychological Services, 2008.
citation: Rutter, R, Bailey, A, Lord, C. Social Communication Questionnaire. Los Angeles: Western Psychological Services, 2003.