Swiss Early Intervention Project in Autism: An Evaluation of Early Intervention Outcome (SwissEIPA)

September 29, 2017 updated by: University of Zurich
This study aims to investigate the effectiveness of early (before the age of 5 years) and intensive intervention for children with Autism Spectrum Disorders.

Study Overview

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.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zurich, Switzerland, 8032
        • Recruiting
        • University of Zurich, Department of Child and Adolescent Psychiatry
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ronnie Gundelfinger, dr. med.
    • Basel Stadt
      • Aesch, Basel Stadt, Switzerland, 4147
        • Recruiting
        • Autismuszentrum GSR
        • Contact:
        • Contact:
    • Vaud
      • Gland, Vaud, Switzerland, 1196
        • Recruiting
        • Association Objectif Vaincre l'Autisme
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
at least 10 hours a week of early intensive behavioral 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.
at least 10 hours a week of early intensive eclectic intervention
Control group
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.
receipt of any Intervention that is less intensive than 10 hours a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autism Diagnostic Observation Schedule-2 (ADOS-2)
Time Frame: Annually up to 3 years
Measures autism symptom severity
Annually up to 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ronnie Gundelfinger, Dr. med., University of Zurich, Department of Child and Adolescent Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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