The Efficacy of Robot-enhanced Therapy for Children With Autism Spectrum Disorders

NCT03323931 | Completed

• 1 other identifier: 30664/10.02.2017
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Autistic Disorders Spectrum

Keywords

autism spectrum disorder; robot-enhanced intervention; imitation; joint attention; turn-taking

Outcome Measures

Primary Outcomes (3)

• Changes in Imitation skills ratings

  Imitation skills will be assessed trough a clinician's rating of the child performance in imitating the behavior of the play partner (robotic or human agent), based on an observation grid.

  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.

• Changes in Joint-attention skills ratings

  This measure is a clinician rating of the child performance in demonstrating and initiating joint attention with the play partner (robotic or human agent), based on an observation grid.

  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.

• Changes in Turn-taking skills ratings

  This measure is a clinician rating of the child performance in demonstrating turn taking skills in the gameplay with the partner (robotic or human agent), based on an observation grid.

  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 (5)

• Changes in Engagement in the task ratings

  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.

• Changes in Verbal utterances ratings

  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.

• Changes in Performance in sharing information task

  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.

• Changes in Performance in sorting in categories task

  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.

• Performance in continuing repetitive patterns task

  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 (2)

• Autism Diagnostic Observation Schedule (ADOS)

  The test will be applied twice: one week before the intervention and one week after the intervention.

• Social Communication Questionnaire (SCQ)

  The test will be applied twice: one week before the intervention and one week after the intervention.

Study Arms (2)

(1) standard therapy

ACTIVE COMPARATOR

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.

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

(2) robot--enhanced intervention

EXPERIMENTAL

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.

Behavioral: (2) robot--enhanced intervention

Interventions

(2) robot--enhanced intervention BEHAVIORAL

The tasks included in the treatment follow a structured behavioral approach, called the discrete trial training (DTT). The learning process is guided by the robotic agent (Softbank Robotics Nao robot). All activities follow a gameplay scenario and they take place at a table, which in the case of joint attention and turn taking tasks incorporates a large touchscreen. Each behavior presented to the child is preceded by instructions and followed by a contingent reinforcement. The contingent reinforcement and prompting are used to train each targeted behavior/action. The behaviors are presented over multiple and successive trials and explicit prompting is giving when the child doesn't succeed to accomplish the targeted behavior. Each action is repeated three times. For every child, the intervention for each ability starts from the level determined in the first two sessions, but as the child's performance improves, the task moves to a more complex level.

Also known as: robot-based intervention, robot-mediated intervention

(2) robot--enhanced intervention

(1) discrete trial training / cognitive-behavior therapy BEHAVIORAL

The tasks included in the treatment follow a structured behavioral approach, called the discrete trial training (DTT). The learning process is guided by an interaction partner (human), under the supervision of the therapist. All activities follow a gameplay scenario and they take place at a table, which in the case of joint attention and turn taking tasks incorporates a large touchscreen. Each behavior presented to the child is preceded by instructions and followed by a contingent reinforcement. The contingent reinforcement and prompting are used to train each targeted behavior/action. The behaviors are presented over multiple and successive trials and explicit prompting is giving when the child doesn't succeed to accomplish the targeted behavior. Each action is repeated three times. For every child, the intervention for each ability starts from the level determined in the first two sessions, but as the child's performance improves, the task moves to a more complex level.

Also known as: ABA, applied behavioral analysis, CBT

(1) standard therapy

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

Sponsors & Collaborators

• Babes-Bolyai University: lead
• University of Skövde: collaborator
• Vrije Universiteit Brussel: collaborator
• University of Plymouth: collaborator
• University of Portsmouth: collaborator
• De Montfort University: collaborator
• SoftBank Robotics: collaborator

Study Sites (1)

Babes-Bolyai University Psychological Clinic

Cluj-Napoca, 400015, Romania

Location

Related Publications (2)

• Lord, C, Rutter, M, DiLavore, PC, Risi, Sl. Autism diagnostic observation schedule: ADOS manual. Los Angeles: Western Psychological Services, 2008.

  BACKGROUND

• Rutter, R, Bailey, A, Lord, C. Social Communication Questionnaire. Los Angeles: Western Psychological Services, 2003.

  BACKGROUND

Related Links

• Site of the DREAM project under which this study is conducted

MeSH Terms

Conditions

Child Development Disorders, Pervasive; Autism Spectrum Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Principal investigator, the research team, and data analyst are all blind to the treatment conditions.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Ph.D.

Model Details: 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).

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: October 27, 2017
• Study Start: March 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

RO (1)