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DAVINCI - A study to the effectiveness of Pivotal Response Treatment in school-aged children with autism spectrum disorder DAVINCI - Onderzoek naar het effect van Pivotal Response Treatment bij kinderen en jongeren met een autisme spectrum stoornis


- candidate number24471
- NTR NumberNTR5893
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jun-2016
- Secondary IDsNL54706.091.15 
- Public TitleDAVINCI - A study to the effectiveness of Pivotal Response Treatment in school-aged children with autism spectrum disorder DAVINCI - Onderzoek naar het effect van Pivotal Response Treatment bij kinderen en jongeren met een autisme spectrum stoornis
- Scientific TitleThe effectiveness of Pivotal Response Treatment in children and adolescents with autism spectrum disorder: A randomized clinical trial
- ACRONYMDAVINCI
- hypothesisPivotal Response Treamtent (PRT) is more effective compared to care-as-usual in:
-improving child social and communicative skills (primary)
-improving child clinical global functioning (secondary)
-improving feelings of competence in parents (secondary)
- Healt Condition(s) or Problem(s) studiedAutism, Autism Spectrum Disorders (ASDs)
- Inclusion criteria-aged 9-15 years at inclusion in the study
-total intelligence quotiŽnt (TIQ) of > 80
-clinically diagnosed with autism spectrum disorder (DSM-IV-TR and DSM-5) or social communication disorder (DSM-5)
-at least one of the parents is able to understand and speak the Dutch language
- Exclusion criteria-Systemic problems that limit the possibility to engage in an intensive treatment, focused on training both the child/adolescent and parents
-presence of comorbid problems that require treatment first
-problems with accepting child's diagnosis of ASD by child and/or parent
-severe parental psychopathology
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2016
- planned closingdate30-sep-2017
- Target number of participants42
- Interventions-Pivotal Response Treatment (PRT): a 12-week intervention for social and communicative skills in children and adolescents with ASD and their caregivers

-care-as-usual: regular treatment of children and adolescents with ASD and their caregivers
- Primary outcome-Significant response on the Social Responsiveness Scale (SRS-2): generalized improvment in child's social and communicative skills
- Secondary outcome-Clinically significant increase at the Clinical Global Impression (CGI) - Improvement scale
-Generalized social and communicative skills (SRS-2), percentage of clinical significant response
-child rearing pressure of parents (Dutch Opvoedingsbelating Vragenlijst, OBVL)
-Change in ASD symptoms (Autism Diagnostic Observation Scedule, ADOS-2)
-Child adaptive behaviour (Vineland Adaptive Behaviour Scales, VABS)
-Child internalizing and externalizing symptoms (Child Behaviour CheckList, CBCL)
- TimepointsThe duration of the treatment within this study is 12 weeks, with an extention of 8 weeks when there is no clinical significant improment on the CGI-I after 12 weeks of treatment. When treatment duration is 20 weeks, the 12-week measure will be an intermediate measure.

T1: week 0 (start of treatment)
T2: week 12 (end of treatment/intermediate measure)
T3: week 20 (follow-up/end of treatment)
T4: week 28 (follow-up/follow-up 2)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc Iris Smeekens
- CONTACT for SCIENTIFIC QUERIESMSc Iris Smeekens
- Sponsor/Initiator Karakter kinder- en jeugdpsychiatrie
- Funding
(Source(s) of Monetary or Material Support)
Stichting Karakter
- Publications
- Brief summaryRationale: Pivotal Response Treatment (PRT) is a promising intervention that focuses on the core symptoms of ASD. Research so far is limited due to methodological shortcomings and there is insufficient scientific evidence that supports the use of PRT in school-aged children and adolescents. The current study aims to address these limitations by focussing on the effectiveness of PRT in children and adolescents with ASD aged 9 - 15, applying a randomized controlled trial.

Objective: The main objective of the current study is to investigate the effectiveness of PRT compared to care-as-usual (CAU) in improving child social and communicative skills and child global clinical functioning after treatment and at 2 month follow up. Secondary parameters are feelings of competence in parents, parent-child interaction, child behaviour problems and child adaptive behaviour.
Additionally, a secondary goal is to assess which child, parent and structural intervention factors influencing effectiveness of treatment.

Study design: A randomized controlled trail with partly blinded measures at end-point and follow-up.
- Main changes (audit trail)
- RECORD10-jun-2016 - 8-jul-2016


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