Swiss Early Intervention Project in Autism: An Evaluation of Early Intervention Outcome

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: Early intensive behavioral intervention; Behavioral: Early intensive eclectic intervention; Other: Treatment as usual

• Registration Number: NCT02302911
• Lead Sponsor: University of Zurich

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-27
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-02
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early intensive behavioral intervention	Early intensive behavioral intervention	Children with a diagnosis of Autism Spectrum Disorder under the age of 5 years that are receiving early intensive behavioral Intervention at one of the participating centres.
Early intensive eclectic intervention	Early intensive eclectic intervention	Children with a diagnosis of Autism Spectrum Disorder under the age of 5 years that are receiving early intensive eclectic Intervention at the participating centre.
Control group	Treatment as usual	Children with a diagnosis of Autism Spectrum Disorder under the age of 5 years that are receiving treatment as usual or no treatment at all.

Primary Outcome Measures

Name	Time	Method
Autism Diagnostic Observation Schedule-2 (ADOS-2)	Annually up to 3 years	Measures autism symptom severity

Secondary Outcome Measures

Name	Time	Method
Questionnaire on Resources and Stress	Annually up to 3 years	Parent questionnaire
Vineland Adaptive Behavior Scales II (VABS)	Annually up to 3 years	Parent interview; adaptive behavior
General Positive Affect Scale	Annually up to 3 years	Parent questionnaire
Positive Gain Scale	Annually up to 3 years	Parent questionnaire
Hospital anxiety and Depression scale	Annually up to 3 years	Parent questionnaire
Strengths and Difficulties Questionnaire	Annually up to 3 years	Parent questionnaire to assess siblings' behavior and potential secondary effects of the intensive Intervention delivered
Snijders-Oomen nicht-verbaler Intelligenztest 2 1/2 - 7 (SON-R)	Annually up to 3 years	IQ measure
Wechsler Preschool and Primary Scale of Intelligence-III (WPPSI-III)	Annually if child is testable up to 3 years	IQ measure

Trial Locations

Locations (3)

Autismuszentrum GSR; 🇨🇭 Aesch, Basel Stadt, Switzerland

Association Objectif Vaincre l'Autisme; 🇨🇭 Gland, Vaud, Switzerland

University of Zurich, Department of Child and Adolescent Psychiatry; 🇨🇭 Zurich, Switzerland