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Prt-based Interventions with robots for training Childen with AutiSm in SOcial and communicative skills


- candidate number19226
- NTR NumberNTR4712
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-aug-2014
- Secondary IDsZonMW PTO project no. 95103010 
- Public TitlePrt-based Interventions with robots for training Childen with AutiSm in SOcial and communicative skills
- Scientific TitleThe effectiveness of a robot-based Pivotal Response Treatment on social and communicative skills in children with autism spectrum disorder: A randomized clinical trial
- ACRONYMPicASSo
- hypothesisPrimary hypotheses:
1) Pivotal Response Treatment (PRT) with the implementation of a robot is more effective compared to PRT provided by a human trainer and compared to care-as-usual only in:
-promoting social and communicative skills in children with ASD (reduction ASD symptoms measured by the SRS)
-providing a clinically significant improvement on mental health (measured by the CGI Improvement Scale)

2) PRT provided by a human trainer is more effective compared to care-as-usual in:
-promoting social and communicative skills in children with ASD (reduction ASD symptoms measured by the SRS)
-providing a clinically significant improvement on mental health (measured by the CGI Improvement Scale)

Secondary hypotheses:
3) PRT with the implementation of a robot is more effective compared to PRT provided by a human trainer in:
-lowering the prompt level (i.e. help that is needed) for communicative skills in children with ASD during treatment
-heightening the number of learning moments the child shows spontaneous appropriate behaviour/initiations on during the treatment
4) The robot that is used in the PRT robot intervention shows a high likability by children with ASD
5) Children with ASD show positive affect during the PRT robot sessions
- Healt Condition(s) or Problem(s) studiedAutism, Autism Spectrum Disorders (ASDs), Social skills, Communication, Intervention
- Inclusion criteria-children aged 3-8 years with a diagnosis of ASD, confirmed by the Autism Diagnostic Interview - Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS)
-IQ > 70
-is able to speak single words at least
-at least one parent speaks Dutch to the child at home
- Exclusion criteria-children of whom medication dosis cannot be fixed during the study
-children who received PRT earlier
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2015
- planned closingdate1-jan-2017
- Target number of participants75
- InterventionsThe study includes 3 intervention conditions, to which participants will be randomly assigned:
1) PRT robot intervention on top of care-as-usual: 20 session of PRT, 30-45 min once a week with the implementation of a robot in the treatment. Pre-progammed scenarios will be used, as well of a text-to-speech functionaliy in which the trainer can instantly fill in the sentences of the robot and provide reinforcement.
2) PRT intervention on top of care-as-usual: PRT that is provided by a human trainer, 20 sessions of 30-45 min once a week
3) care-as-usual: includes different treatments, mainly psycho-education and guidance of partents. Duration is variable.
- Primary outcome1) Report of partent and teacher:
-Social Responsiveness Scale (SRS): ASD symptoms of the child, with the focus on social and communicative skills
2) Report of child psychiatrist:
-Clinical Global Impression Improvement Scale (CGI-I): a general impression on the improvement in mental health of the child with ASD
- Secondary outcomeRated by trained psychologist:
1) Prompting requirement of communicative skills (CS) during PRT sessions
2) Number of learning moments (LM) in which the child shows spontaneous appropriate behaviour (e.g. initiations)
Rated by child:
3) Visual Analogue scale (VAS): likability of the robot and child's affect during PRT robot treatment
- TimepointsAfter administration of measures for assessing inclusion criteria (i.e. demographic information, ADI-R, ADOS, Wechsler scales), the outcome measures are adminitered at the following time points:
-week 0: baseline: SRS, CGI-I in all intervention groups, CS in PRT intervention groups
-week 1-20: intervention: LM in PRT intervention groups, VAS in PRT robot intervention group
-week 5,10,15,20: SRS, CGI-I in all intervention groups, CS in PRT intervention groups
-week 32: follow-up: SRS, CGI-I in all intervention groups, CS in PRT intervention groups
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc Iris Smeekens
- CONTACT for SCIENTIFIC QUERIESPhD. Jeffrey Glennon
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryAutism spectrum disorder (ASD) includes deficits in social communication and social interaction that are presistent across lifespan. Despite the heavy burden on individuals and their families, the high prevalence of ASD and the high costs for society, no effective pharmacologic interventions are currently available to treat the core symptoms of ASD. Pivotal Response Treatment (PRT), an approach based on principles of applied behaviour analysis (ABA), has been proven effective in promoting social and communicative skills in children with ASD. Also, implementing robots in the treatment of children with ASD seems promising due to the intrinsic attractiveness to these children an the robot behaviour that can be controlled and easily adjusted in complexity.

Although results are promising, earlier studies to the effectiveness of PRT and the implementation of robotics into the treatment of ASD show metholodigcal limitations, such as small sample sizes and the lack of an experimental design. Also, there is a lack of studies that integrate robotics into an empirically supported treatment for children with ASD.
The current study will address the limitations in earlier studies by:
-conducting a well-designed randomized clinical trial
-including a relatively high number of participants (i.e. 75)
-confirming diagnosis of ASD by 'gold standard' instruments
-including both quantitative and qualitative measures of treatment effectiveness
-implementing a robot into an empirically supported treatment for children with ASD (i.e. PRT)
-measuring generalization of skills into the natural enviroment of children
- Main changes (audit trail)
- RECORD1-aug-2014 - 30-jul-2015


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