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

Primary Purpose

Autistic Disorders Spectrum

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
(2) robot--enhanced intervention
(1) discrete trial training / cognitive-behavior therapy
Sponsored by
Babes-Bolyai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorders Spectrum focused on measuring autism spectrum disorder, robot-enhanced intervention, imitation, joint attention, turn-taking

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Babes-Bolyai University Psychological Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

(1) standard therapy

(2) robot--enhanced intervention

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Changes in Engagement in the task ratings
This measure is a clinician rating of the child engagement in the game play with the partner (robotic or human agent), based on an observation grid.
Changes in Verbal utterances ratings
This measure is a clinician rating of the child child expression of verbal utterances in relation to the gameplay with the partner (robotic or human agent). The frequency of verbal utterances is recorded for this outcome.
Changes in Performance in sharing information task
Performance in a task where the child is asked to share some personal information regarding own preferences by choosing a picture on the touchscreen.
Changes in Performance in sorting in categories task
Performance in a task where the child is asked to categorize some objects by moving a picture on the touchscreen over another picture depicting and object that belongs to the same category.
Performance in continuing repetitive patterns task
Performance in a task where the child is asked to chose an object from several others that match the pattern of a pre-existing series of objects (e.g., based on geometrical shape or color).

Full Information

First Posted
September 5, 2017
Last Updated
May 12, 2019
Sponsor
Babes-Bolyai University
Collaborators
University of Skövde, Vrije Universiteit Brussel, University of Plymouth, University of Portsmouth, De Montfort University, SoftBank Robotics
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1. Study Identification

Unique Protocol Identification Number
NCT03323931
Brief Title
The Efficacy of Robot-enhanced Therapy for Children With Autism Spectrum Disorders
Acronym
DREAM-RCT
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Babes-Bolyai University
Collaborators
University of Skövde, Vrije Universiteit Brussel, University of Plymouth, University of Portsmouth, De Montfort University, SoftBank Robotics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorders Spectrum
Keywords
autism spectrum disorder, robot-enhanced intervention, imitation, joint attention, turn-taking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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).
Masking
Investigator
Masking Description
Principal investigator, the research team, and data analyst are all blind to the treatment conditions.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(1) standard therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
(2) robot--enhanced intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
(2) robot--enhanced intervention
Other Intervention Name(s)
robot-based intervention, robot-mediated intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
(1) discrete trial training / cognitive-behavior therapy
Other Intervention Name(s)
ABA, applied behavioral analysis, CBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Imitation skills ratings
Description
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.
Time Frame
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.
Title
Changes in Joint-attention skills ratings
Description
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.
Time Frame
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.
Title
Changes in Turn-taking skills ratings
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Changes in Engagement in the task ratings
Description
This measure is a clinician rating of the child engagement in the game play with the partner (robotic or human agent), based on an observation grid.
Time Frame
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.
Title
Changes in Verbal utterances ratings
Description
This measure is a clinician rating of the child child expression of verbal utterances in relation to the gameplay with the partner (robotic or human agent). The frequency of verbal utterances is recorded for this outcome.
Time Frame
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.
Title
Changes in Performance in sharing information task
Description
Performance in a task where the child is asked to share some personal information regarding own preferences by choosing a picture on the touchscreen.
Time Frame
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.
Title
Changes in Performance in sorting in categories task
Description
Performance in a task where the child is asked to categorize some objects by moving a picture on the touchscreen over another picture depicting and object that belongs to the same category.
Time Frame
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.
Title
Performance in continuing repetitive patterns task
Description
Performance in a task where the child is asked to chose an object from several others that match the pattern of a pre-existing series of objects (e.g., based on geometrical shape or color).
Time Frame
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 Pre-specified Outcome Measures:
Title
Autism Diagnostic Observation Schedule (ADOS)
Description
ADOS (Lord, Rutter, DiLavore, & Risi, 2008) is a clinician rated semi-structured set of activities designed for observing behaviors that are relevant to judge presence of the diagnostic criteria for autism spectrum disorder.
Time Frame
The test will be applied twice: one week before the intervention and one week after the intervention.
Title
Social Communication Questionnaire (SCQ)
Description
SCQ (Rutter, Bailey & Lord) is a other-report questionnaire used for autism spectrum disorders screening and assessment. The questionnaire is filled by the parents or another tutor in relation to the social skills and social functioning of the child.
Time Frame
The test will be applied twice: one week before the intervention and one week after the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Babes-Bolyai University Psychological Clinic
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania

12. IPD Sharing Statement

Citations:
Citation
Lord, C, Rutter, M, DiLavore, PC, Risi, Sl. Autism diagnostic observation schedule: ADOS manual. Los Angeles: Western Psychological Services, 2008.
Results Reference
background
Citation
Rutter, R, Bailey, A, Lord, C. Social Communication Questionnaire. Los Angeles: Western Psychological Services, 2003.
Results Reference
background
Links:
URL
http://www.dream2020.eu
Description
Site of the DREAM project under which this study is conducted

Learn more about this trial

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

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