Clinical trial NCT02302911: Swiss Early Intervention Project in Autism: An Evaluation of Early Intervention Outcome
Official title: Swiss Early Intervention Project in Autism: An Evaluation of Early Intervention Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Keywords: Early intervention
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 90
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Experimental Groups: Child with Autism Spectrum Disorder diagnosis referred to one of the EIBI or EIEI Service Provider receiving Treatment as of January 2013.

Control Group: Child with Autism Spectrum Disorder diagnosis receiving Treatment as usual and willing to participate

Brief summary: This study aims to investigate the effectiveness of early (before the age of 5 years) and intensive intervention for children with Autism Spectrum Disorders.

Detailed description: This study aims to investigate the effectiveness of early (before the age of 5 years) and intensive intervention for children with Autism Spectrum Disorders. The type of intervention proposed in Switzerland differs greatly depending on where people live. Several international studies show positive outcomes in children with Autism after receiving early behavioural intervention.

However, Disability Insurance (DI) in Switzerland does not fully cover these scientifically proven interventions. Since January 2014 they cover 45 000 CHF per child for only two years of early treatment across five centres chosen by the Federal Social Insurance Office. The remaining costs are covered by the parents, foundations or by the cantons. In addition, families benefit from this early intervention only if their child is enrolled in one of the five selected centres.

There are currently various types of support for children with Autism in Switzerland before age five, early intensive behavioural interventions, eclectic early intervention and less intensive interventions with a treatment that is not specific to Autism (about 3 hrs./week), which includes occupational therapy, speech therapy and early curative education. Some children do not receive any treatment.

This research aims to evaluate the efficacy of these interventions (early intensive behavioural/ eclectic/treatment as usual) as has been done previously in international studies. The study also aims to include centres other than those selected by the Swiss Federal Social Insurance Office.

Eligibility criteria: Inclusion criteria:

* For all groups:
* parents speak English, German or French
* diagnosis of Autism or Pervasive Developmental Disorder not otherwise specified
* 5 years or younger at the start of Intervention
* parents consent
* Experimental Group:
* family was accepted by one of the participating Service Providers

Exclusion Criteria:

* Experimental Group:
* receipt of a second intervention that either interferes with the intensive Intervention or is also intensive (more than 10 hours a week)
* Comparison Group:
* receipt of any Intervention that is more than 10 hours a week

Primary outcomes:
measure: Autism Diagnostic Observation Schedule-2 (ADOS-2)
timeFrame: Annually up to 3 years
Secondary outcomes:
measure: Positive Gain Scale
timeFrame: Annually up to 3 years
measure: General Positive Affect Scale
timeFrame: Annually up to 3 years
measure: Questionnaire on Resources and Stress
timeFrame: Annually up to 3 years
measure: Hospital anxiety and Depression scale
timeFrame: Annually up to 3 years
measure: Strengths and Difficulties Questionnaire
timeFrame: Annually up to 3 years
measure: Vineland Adaptive Behavior Scales II (VABS)
timeFrame: Annually up to 3 years
measure: Snijders-Oomen nicht-verbaler Intelligenztest 2 1/2 - 7 (SON-R)
timeFrame: Annually up to 3 years
measure: Wechsler Preschool and Primary Scale of Intelligence-III (WPPSI-III)
timeFrame: Annually if child is testable up to 3 years
Other outcomes:
Locations:
city: Aesch
country: Switzerland
facility: Autismuszentrum GSR
state: Basel Stadt
city: Gland
country: Switzerland
facility: Association Objectif Vaincre l'Autisme
state: Vaud
city: Zurich
country: Switzerland
facility: University of Zurich, Department of Child and Adolescent Psychiatry
Study officials:
affiliation: University of Zurich, Department of Child and Adolescent Psychiatry
name: Ronnie Gundelfinger, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: