NCT02302911

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

5.9 years

First QC Date

October 23, 2014

Last Update Submit

September 29, 2017

Conditions

Autism Spectrum Disorder

Keywords

Early intervention

Outcome Measures

Primary Outcomes (1)

  • Autism Diagnostic Observation Schedule-2 (ADOS-2)

    Measures autism symptom severity

    Annually up to 3 years

Secondary Outcomes (8)

  • Positive Gain Scale

    Annually up to 3 years

  • General Positive Affect Scale

    Annually up to 3 years

  • Questionnaire on Resources and Stress

    Annually up to 3 years

  • Hospital anxiety and Depression scale

    Annually up to 3 years

  • Strengths and Difficulties Questionnaire

    Annually up to 3 years

  • +3 more secondary outcomes

Study Arms (3)

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

Early intensive behavioral interventionBEHAVIORAL

at least 10 hours a week of early intensive behavioral intervention

Early intensive behavioral intervention
Early intensive eclectic interventionBEHAVIORAL

at least 10 hours a week of early intensive eclectic intervention

Early intensive eclectic intervention
Treatment as usualOTHER

receipt of any Intervention that is less intensive than 10 hours a week

Control group

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • For all groups:
  • parents speak English, German or French
  • diagnosis of Autism or Pervasive Developmental Disorder not otherwise specified
  • years or younger at the start of Intervention
  • parents consent
  • Experimental Group:
  • family was accepted by one of the participating Service Providers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Autismuszentrum GSR

Aesch, Canton of Basel-City, 4147, Switzerland

RECRUITING

Association Objectif Vaincre l'Autisme

Gland, Canton of Vaud, 1196, Switzerland

RECRUITING

University of Zurich, Department of Child and Adolescent Psychiatry

Zurich, 8032, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

no biospecimens are being retained

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ronnie Gundelfinger, Dr. med.

    University of Zurich, Department of Child and Adolescent Psychiatry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronnie Gundelfinger, Dr. med.

CONTACT

+41 44 499 26 26ronnie.gundelfinger@puk.zh.ch

Nadja L Studer, lic. phil.

CONTACT

+41 44 499 26 26nadja.studer@puk.zh.ch

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2014

First Posted

November 27, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

CH(3)