Swiss Early Intervention Project in Autism: An Evaluation... | NCT02302911

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

NCT02302911

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Oct 2, 2017Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Autism Spectrum Disorder

Interventions

Early intensive behavioral intervention
Early intensive eclectic intervention
Treatment as usual

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Oct 23, 2014

First Submission Date that Met QC Criteria

Nov 24, 2014

First Posted Date

Nov 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2017

Last Update Posted Date

Oct 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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.	Behavioral: 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.	Behavioral: 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.	Other: Treatment as usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early intensive behavioral intervention	Behavioral	at least 10 hours a week of early intensive behavioral intervention	Early intensive behavioral intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Positive Gain Scale	Parent questionnaire	Annually up to 3 years
General Positive Affect Scale	Parent questionnaire	Annually up to 3 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

5 Years

Standard Ages

Child

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ronnie Gundelfinger, Dr. med.	Contact	+41 44 499 26 26		ronnie.gundelfinger@puk.zh.ch
Nadja L Studer, lic. phil.	Contact	+41 44 499 26 26		nadja.studer@puk.zh.ch

Overall Officials

Name	Affiliation	Role
Ronnie Gundelfinger, Dr. med.	University of Zurich, Department of Child and Adolescent Psychiatry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Autismuszentrum GSR	Recruiting	Aesch	Canton of Basel-City	4147	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided