An interventional study of (2) robot--enhanced intervention and (1) discrete trial training / cognitive-behavior therapy in Autistic Disorders Spectrum, sponsored by Babes-Bolyai University. Completed at 1 site in Romania. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2019-05-14.
Sponsored by Babes-Bolyai University · Not applicable, Interventional, and Treatment
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.
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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's enrollment of 70 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Babes-Bolyai University is the lead sponsor of 51 studies on the registry; 13 are open to participants now.
Compared within Autism Spectrum Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Child Development Disorders, Pervasive. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
Autism Diagnostic Observation Schedule (ADOS)
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.
Social Communication Questionnaire (SCQ)
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.
Ran from Mar 2017 to primary completion in Dec 2018, 21 months.
Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 21 months is below that.
Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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