No registrations found.
ID
Source
Brief title
Health condition
* Autism spectrum disorder
* ASD
* Autism
* PDD-NOS
* Borderline intellectual functioning
* Intellectual disability
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary 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 outcome
Not applicable.
Background summary
Rationale: 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
Study objective
Main 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".
Study design
First assessment: at the start of the interveniotn.
Second assessment: one week after completing the intervention.
Follow up: six months after completing the intervention.
Intervention
Two 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.
N. Molendijk
Oosterbeek 6862 BC
The Netherlands
0031 26 4002100
n.molendijk@karakter.com
N. Molendijk
Oosterbeek 6862 BC
The Netherlands
0031 26 4002100
n.molendijk@karakter.com
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4290 |
NTR-old | NTR4434 |
Other | Commissie Mensgebonden Onderzoek, Radboud Universitair Medisch Centrum : 2013/370, NL nr.: 45653.091.13 |