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van CCT (UK)

van CCT (UK)

Improving emotion recognition in children with Autism Spectrum Disorders and intellectual disabilities

- candidate number16439
- NTR NumberNTR4434
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-feb-2014
- Secondary IDs2013/370, NL nr.: 45653.091.13 Commissie Mensgebonden Onderzoek, Radboud Universitair Medisch Centrum
- Public TitleImproving emotion recognition in children with Autism Spectrum Disorders and intellectual disabilities
- Scientific TitleImproving emotion recognition in children with Autism Spectrum Disorders and Borderline Intellectual Functioning: A Randomized Double-blind Placebo-controlled Intervention Study
- ACRONYMImproving emotion recognition in children with ASD and BIF.
- hypothesisMain hypothesis: The group of children with ASD and BIF that receive "The Transporters" will show significantly more improvement in contextual understanding of emotions and social functioning than the group of children with ASD and BIF that receive the control intervention "Thomas & Friends".
- Healt Condition(s) or Problem(s) studiedAutism, Autism Spectrum Disorders (ASDs), Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS), Borderline intellectual functioning
- Inclusion criteria* Children aged between 6 years, 0 months and 9 years, 11 months - known in psychiatric health care * Children with an Autism Spectrum Disorder, classified by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). * IQ scores between 70 and 85 ('borderline intellectual functioning') * Access to a PC or TIV with DVD-player * A comorbid ADHD diagnosis is allowed, as long as it is sufficiently treated with medication and dosage is stabile during the intervention.
- Exclusion criteria* Currenlty intensive (ie weekly) individual or group therapy * Diagnosis of one or more of the following comorbid psychiatric disorders: - major depression - psychotic disorder - conduct disorder - attachment disorder - serious moto and/or perceptual disability * Simultaneous participation in another clinical trial * Insufficient motivation for the completing the treatment * Medical illness that needs treatment.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate1-dec-2015
- Target number of participants44
- InterventionsTwo groups of children, randomly assigned to either the treatment condition or placebo group, are compared to each other. The intervention group watches the specifically designed DVD series called 'The Transporter'. The control group children receive a DVD of existing DVD episodes of 'Thomas & Friends', assembled specifically for this study. Both groups watch the DVD for 15 minutes a day, 5 days a week over the course of 4 weeks. In both groups, parents are actively involved in the treatment of their children by discussing certain specified topics using a diary and in helping their children make the generalisation across different settings.
- Primary outcomePrimary outcomes includ neuro-cognitive functioning of the children, social information processing and scores on social behavioral questionnaires. Each of the parameters is assessed at the start of treatment, right after and six months after completing the intervention.
- Secondary outcomeNot applicable.
- TimepointsFirst assessment: at the start of the interveniotn. Second assessment: one week after completing the intervention. Follow up: six months after completing the intervention.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Karakter kinder- en jeugdpsychiatrie
- Funding
(Source(s) of Monetary or Material Support)
Karakter Kinder- en Jeugdpsychiatrie
- PublicationsNot applicable
- Brief summaryRationale: Social skills are crucial for adapting to an increasingly complex social world during development. The implications of impaired social skills for mental well-being have called for identifying interventions that enhance social cognitive functioning and specifically target the core cognitive problems. Most social skills interventions are developed for children with autism spectrum disorders (ASD). However, approximately 50% of individuals with ASD have comorbid intellectual disabilities. The Transporters, an animated series designed to improve emotion comprehension in children with ASD, is a promising intervention for this specific group, given the visual nature, the frequent repetition and the small steps in which new information is being introduced. This study evaluates the efficacy of The Transporters in children with ASD an Borderline Intellectual Functioning (BIF, 70
- Main changes (audit trail)
- RECORD14-feb-2014 - 7-apr-2014

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