To test the hypothesis that The Transporters will show significant more improvement in contextual understanding of emotions and social functioning in children with ASD and BIF than a control intervention.
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study parameters include neurocognitive performance, social information
processing tasks (i.e. reaction times and percentage correct) and measures on
social behavioral questionnaires.
Secondary outcome
n/a
Background summary
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 at 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
To test the hypothesis that The Transporters will show significant more
improvement in contextual understanding of emotions and social functioning in
children with ASD and BIF than a control intervention.
Study design
Randomized double-blind placebo-controlled intervention study. Subjects are
randomly allocated using stratification by age (6;0 - 7;11 and 8;0 - 9;11
years) and comorbid attention deficit hyperactivity disorder (ADHD) (a comorbid
diagnosis of ADHD or not), with computer-generated probabilistic minimization.
Intervention
Two groups of 22 children will be compared. The intervention group will be
watching The Transporters DVD, and the control group watches a purpose built
DVD of Thomas and Friends, consisting of selected episodes of the series that
draw attention to emotions or affect. The duration of the treatment for both
groups is 15 minutes, 5 days a week for 4 weeks. In both groups children will
be actively supervised by their parents. Before and after the treatment, all
children will undergo a neurocognitive assessment (pre- en post- assessment)
and parents and teachers will complete several questionnaires. In the week
after the last session, the post-assessment will be done and an evaluation of
the treatment will take place. Six months after the last treatment session
there will be a follow-up.
Study burden and risks
The burden and risks for the children and parents are minimal, since the
largest part of the assessment is care as usual at Karakter. The requested time
investment is a total of 4 1/2 hours (distributed over 3 visits). The
researchers are skilled in working with children with ASD and BIF and our
experience is that children enjoy the cognitive computer *games* and watching
the DVD*s.
Utrechtseweg 320
Oosterbeek 6862 BC
NL
Utrechtseweg 320
Oosterbeek 6862 BC
NL
Listed location countries
Age
Inclusion criteria
1. Children aged between 6 years/0 months and 9 years/11 months, known in psychiatric health care.
2. Autism Spectrum Disorder, classified by the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 2000).
3. IQ score between 70 and 85 (BIF).
4. Access to a PC or TV with DVD player.
5. A comorbid ADHD diagnose is allowed, as long as sufficiently treated with medication and dosage stays to be fixed during this intervention.
Exclusion criteria
1. Currently intensive (i.e. weekly) individual or grouptherapy.
2. Diagnosis of one or more of the following comorbid psychiatric disorders:
- Major depression
- Bipolar disorder
- Psychotic disorder
- Conduct disorder
- Attachment disorder
- Serious motor and/or perceptual handicap.
3. Participation in another clinical trial simultaneously.
4. Insufficient motivation to follow the treatment.
5. Medical illness which needs medical 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 |
|---|---|
| CCMO | NL45653.091.13 |