- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02302911
Swiss Early Intervention Project in Autism: An Evaluation of Early Intervention Outcome (SwissEIPA)
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8032
- Recruiting
- University of Zurich, Department of Child and Adolescent Psychiatry
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Contact:
- Ronnie Gundelfinger, Dr. med.
- Phone Number: +41 44 499 26 26
- Email: ronnie.gundelfinger@puk.zh.ch
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Contact:
- Nadja Studer, lic. phil.
- Phone Number: +41 44 499 26 26
- Email: nadja.studer@puk.zh.ch
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Principal Investigator:
- Ronnie Gundelfinger, dr. med.
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Basel Stadt
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Aesch, Basel Stadt, Switzerland, 4147
- Recruiting
- Autismuszentrum GSR
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Contact:
- Bettina Tillmann, Dr. med.
- Phone Number: +41 61 645 88 08
- Email: bettina.tillmann@gsr.ch
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Contact:
- Peter Weber, Prof Dr med
- Phone Number: +41 61 645 88 08
- Email: peter.weber@ukbb.ch
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Vaud
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Gland, Vaud, Switzerland, 1196
- Recruiting
- Association Objectif Vaincre l'Autisme
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Contact:
- Charlotte Escané, MSc
- Phone Number: +41 22 360 03 49
- Email: recherche@ovassocation.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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.
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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.
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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
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Parent questionnaire
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Annually up to 3 years
|
|
Questionnaire on Resources and Stress
Time Frame: Annually up to 3 years
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Parent questionnaire
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Annually up to 3 years
|
|
Hospital anxiety and Depression scale
Time Frame: Annually up to 3 years
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Parent questionnaire
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Annually up to 3 years
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Strengths and Difficulties Questionnaire
Time Frame: Annually up to 3 years
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Parent questionnaire to assess siblings' behavior and potential secondary effects of the intensive Intervention delivered
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Annually up to 3 years
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Vineland Adaptive Behavior Scales II (VABS)
Time Frame: Annually up to 3 years
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Parent interview; adaptive behavior
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Annually up to 3 years
|
|
Snijders-Oomen nicht-verbaler Intelligenztest 2 1/2 - 7 (SON-R)
Time Frame: Annually up to 3 years
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IQ measure
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Annually up to 3 years
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Wechsler Preschool and Primary Scale of Intelligence-III (WPPSI-III)
Time Frame: Annually if child is testable up to 3 years
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IQ measure
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Annually if child is testable up to 3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ronnie Gundelfinger, Dr. med., University of Zurich, Department of Child and Adolescent Psychiatry
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SWEIPA
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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