The Efficacy of Robot-enhanced Therapy for Children With Autism Spectrum Disorders (DREAM-RCT)

Babes-Bolyai University

Status: Completed

Conditions: Autistic Disorders Spectrum

Treatments: Behavioral: (2) robot--enhanced intervention; Behavioral: (1) discrete trial training / cognitive-behavior therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03323931

30664/10.02.2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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70 participants in 2 patient groups

(1) standard therapy

Active Comparator group

Description:

Standard therapy based on Applied Behavioral Analysis (ABA) and Cognitive-Behavior-Therapy (CBT). It implies structured activities in which the therapist reinforces the adaptive behavior of the child.

Treatment:

Behavioral: (1) discrete trial training / cognitive-behavior therapy

(2) robot--enhanced intervention

Experimental group

Description:

A treatment developed on the same principles as standard therapy, based on Applied Behavioral Analysis (ABA) and Cognitive-Behavior-Therapy (CBT). It implies structured activities in which the robotic agent reinforces the adaptive behaviors of the child, under the supervision of the therapist.

Treatment:

Behavioral: (2) robot--enhanced intervention