No registrations found.
ID
Source
Brief title
Health condition
autism spectrum disorder, ASD, autisme, autisme spectrum stoornis, ASS
Sponsors and support
Postbus 68
6710 BB Ede, The Netherlands
Email: info@karakter.com
Kvk-nummer: 41245075
Fonds NutsOhra
Postbus 229
1000 AE Amsterdam, The Netherlands
Email: info@fondsnutsohra.nl
KvK-nummer: 40124985
Intervention
Outcome measures
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)
Background summary
Rationale: 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.
Study objective
Pivotal 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)
Study design
The 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)
Intervention
-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
Department of Cognitive Neuroscience - HP126 <br>
Postbox 9101
Iris Smeekens
Nijmegen 6500HB
The Netherlands
(0031)24-3613680
Iris.Smeekens@radboudumc.nl
Department of Cognitive Neuroscience - HP126 <br>
Postbox 9101
Iris Smeekens
Nijmegen 6500HB
The Netherlands
(0031)24-3613680
Iris.Smeekens@radboudumc.nl
Inclusion criteria
-aged 9-15 years at inclusion in the study
-total intelligence quotiënt (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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5476 |
| NTR-old | NTR5893 |
| CCMO | NL54706.091.15 |
| OMON | NL-OMON44124 |