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

Autism Spectrum Disorder Clinical Trial

— SwissEIPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02302911
• Other study ID #: SWEIPA
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2014
• Last updated: September 29, 2017
• Start date: January 2013
• Est. completion date: December 2018

Study information

• Verified date: September 2017
• Source: University of Zurich
• Contact: Ronnie Gundelfinger, Dr. med.
• Phone: +41 44 499 26 26
• Email: ronnie.gundelfinger[@]puk.zh.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Early intensive behavioral intervention
at least 10 hours a week of early intensive behavioral intervention
• Early intensive eclectic intervention
at least 10 hours a week of early intensive eclectic intervention

Other:
• Treatment as usual
receipt of any Intervention that is less intensive than 10 hours a week

Locations

Country	Name	City	State
Switzerland	Autismuszentrum GSR	Aesch	Basel Stadt
Switzerland	Association Objectif Vaincre l'Autisme	Gland	Vaud
Switzerland	University of Zurich, Department of Child and Adolescent Psychiatry	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

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