|- candidate number||8208|
|- NTR Number||NTR2405|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jul-2010|
|- Secondary IDs||2009.320 / 157003005 METC / ZonMW |
|- Public Title||Evaluation of a social skills training for children with autism spectrum disorders: Generalisation of skills by training parents and teachers?|
|- Scientific Title||Evaluation of a social skills training for children with autism spectrum disorders (ASDs): Generalisation of skills by training parents and teachers?|
|- ACRONYM||ESTIA: Efficacy of Social skills training in children with ASDs|
|- hypothesis||Social skills training will increase the social and communicative skills in daily life situations of children with ASDs as compared to children who do not follow such training. Additionally, training parents and teachers will increase generalisation of the social and communicative skills outside the training of children with ASDs who follow a social skills training.|
|- Healt Condition(s) or Problem(s) studied||Autism Spectrum Disorders (ASDs)|
|- Inclusion criteria||1. Clinical DSM-IV-TR classification of a Pervasive developmental Disorder (AD, Asperger Syndrome or PDD-NOS);|
2. Classification AD on the Autism Diagnostic Interview-Revised, or 2 points below the cut-off for AD;
3. Classification of ASD on the Autism Diagnostic Observation Schedule;
4. Level of cognitive functioning above level of intellectual disability;
5. Child attends one of the two last years of primary education (or the equivalent in special education);
6. Parents (and child if above 12 years) give informed consent for participation.
|- Exclusion criteria||1. A known physical condition that interferes with participation;|
2. Impossibility to visit the outpatient clinic for a training.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2009|
|- planned closingdate||1-dec-2013|
|- Target number of participants||120|
|- Interventions||Children in the first intervention group (SST) will receive a protocolled Social Skills training of 15 weekly sessions of 1.5 hours, and three monthly booster sessions starting 2 months after the last regular session.
Children in the other intervention group (SST+) will receive the same training. Additionally, their parents will receive a protocolled Parent Managment Training (PMT) of 8 session of 1.5 hours. The first three sessions will be given before and the other five during the training of the children. Focus of the PMT is on psychoeducation and on helping the child practice and generalise social skills. Also, teachers will be involved in this condition.
The control group receives care-as-usual, without specific focus on social skills.
|- Primary outcome||Primary outcome of the study is adaptive functioning of the child, as measured with the Vineland. The instrument measures social and communicative skills as applied in daily life situations. The instrument is administered to parents before the training (t0), after the 15 sessions (t1,; 6 months after t0) and at follow-up (t2; 12 months after t0).|
|- Secondary outcome||1. Change on the training-skills of the 15 sessions (t0, t1 and t2);|
2. SSRS, SNAP IV, P/T (P t0, t1 and t2, T t0 and t1));
3. FMSS, RCADS P (t0. t1 and t2);
4. ADOS (t0, t1 and t2);
5. Direct observation of the child in a free play situation in school (t1, intervention groups only).
|- Timepoints||All parent and child measures will be administered before start of the training (or care-as-usual), at 6 months and at 12 months. All teacher measures will be administered before start and at 6 months, due to change of teacher from one schoolyear to another.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| A. Bildt, de|
|- CONTACT for SCIENTIFIC QUERIES|| A. Bildt, de|
|- Sponsor/Initiator ||Accare, Division University Center for Child and Adolescent Psychiatry, Lentis, Axenza, Autisme team Noord-Nederland|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Accare, Lentis, Autisme team Noord Nederland |
|- Brief summary||Social skills are limited in children with Autism Spectrum Disorders (ASDs). Social skills trainings are widely available in all kinds of settings and based on a wide variety of methods. The assumption is that the children can generalise the skills taught in the training to their homes and schools. However, little empirical evidence exists on the effectiveness of social skills training in general and on the generalization of the learned skills in particular. The current study aims to investigate the effectiveness of a social skills training based on a clear protocol. Specific focus will be on the generalization of skills to situations outside the training, by involving parents and teachers before and during the training.|
Suggestions from the literature on what has been missing in former studies will be incorporated: focus on generalization of skills, a Randomized Controlled Trial, large enough number of participants, standardised outcome measures, and a standardised protocol for the training. Based on the current study we hope to be able to pronounce upon the efficacy of a social skills training for children with ASDs.
|- Main changes (audit trail)|
|- RECORD||5-jul-2010 - 23-aug-2010|