Autistic Disorders Spectrum Clinical Trial
— DREAM-RCTOfficial title:
DREAM Project Trial: Testing the Efficacy of Robot-enhanced Therapy for Children With Autism Spectrum Disorders in a Randomised Clinical Trial
Verified date | May 2019 |
Source | Babes-Bolyai University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Romania | Babes-Bolyai University Psychological Clinic | Cluj-Napoca |
Lead Sponsor | Collaborator |
---|---|
Babes-Bolyai University | De Montfort University, SoftBank Robotics, University of Plymouth, University of Portsmouth, University of Skövde, Vrije Universiteit Brussel |
Romania,
Lord, C, Rutter, M, DiLavore, PC, Risi, Sl. Autism diagnostic observation schedule: ADOS manual. Los Angeles: Western Psychological Services, 2008.
Rutter, R, Bailey, A, Lord, C. Social Communication Questionnaire. Los Angeles: Western Psychological Services, 2003.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | The test will be applied twice: one week before the intervention and one week after the intervention. | |
Other | 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. | The test will be applied twice: one week before the intervention and one week after the intervention. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | 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. | 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. | |
Secondary | 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. | 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. | |
Secondary | 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. | 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. | |
Secondary | 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. | 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. | |
Secondary | 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). | 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. |
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