|- candidate number||8068|
|- NTR Number||NTR2327|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-mei-2010|
|- Secondary IDs|| |
|- Public Title||Theory of Mind training in children with autism.|
|- Scientific Title||Theory of Mind training in children with autism: A randomized controlled trial.|
|- hypothesis||1. The treatment group will increase their Theory of Mind skills in comparison to the waitlist control group;|
2. The conceptual skills will improve at a higher rate than the practical skills.
|- Healt Condition(s) or Problem(s) studied||Autism, Social cognition, Theory of Mind|
|- Inclusion criteria||1. A clinical diagnosis within the Autism Spectrum according to the DSM-IV criteria;|
2. Age between 8-13;
3. Informed consent.
|- Exclusion criteria||Intellectual impairment (IQ<80).|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2010|
|- planned closingdate||1-mei-2012|
|- Target number of participants||100|
|- Interventions||Treatment group: The Theory of Mind training is a manualized treatment program, that includes 8 weekly sessions of approximately 1,5 hour each, provided to 5 or 6 children simultaneously. The training includes a variety of structured activities, wich increasingly focus on the use of Theory of Mind skills. Additionaly parents attend two parent trainingsessions, where they are informed about the content of the training and about the progress of their children, and given suggestions how to promote social cognition.
Waitlist control group: Care as usual.
|- Primary outcome||Conceptual skills:|
1. Emotion understanding (LEAS-C);
2. Theory of Mind (ToM advanced test and TOM-test).
1. Social Skills (SSQ-P);
2. Social Skills (SSQ-T);
3. Social Responsiveness Scale (SRS);
4. Direct social behavior.
|- Secondary outcome||1. Social Responsiveness Scale (SRS);|
2. Wing Subtypes Questionnaire;
3. Vragenlijst voor Gedragsproblemen bij Kinderen (VvGK);
4. Peabody Picture Vocabulary Test-III (PPVT-III-NL).
|- Timepoints||1. Baseline;|
2. Posttest (2 months);
3. Follow up (6 months).
|- Trial web site||www.ara.vu.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. S. Begeer|
|- CONTACT for SCIENTIFIC QUERIES||Dr. S. Begeer|
|- Sponsor/Initiator ||De Bascule, Academic Center for Child and Adolescent Psychiatry (Amsterdam), VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Fonds Psychische Gezondheid|
|- Brief summary||At some point in their lives, most children with autism are treated with a social skills training program. In most cases, these treatments include the training of empathic skills, or Theory of Mind. Despite the multitude of children that are participating in these forms of treatment, few studies have shown evidence for their effectiveness. The current study uses a randomized controlled design tot test the effectiveness of a 8-week Theory of Mind training in 8 to 13 year old children with Autism Spectrum disorders. It examines which patients with which characteristics (like type of diagnoses, Wing-subtypes, comorbidity) will benefit most from the intervention. The study will differentiate between conceptual and practical social skills. |
|- Main changes (audit trail)|
|- RECORD||17-mei-2010 - 28-mei-2010|