Autism Spectrum DisorderSwissEIPANCT02302911
Swiss Early Intervention Project in Autism: An Evaluation of Early Intervention Outcome
An observational study of Autism Spectrum Disorder, run by University of Zurich at 3 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Early intensive behavioral intervention, Early intensive eclectic intervention and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Jan 2013to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites, 3 recruiting
- Recruiting
Autismuszentrum GSR
Aesch, Canton of Basel-City, 4147
Bettina Tillmann, Dr. med., +41 61 645 88 08, bettina.tillmann@gsr.ch
Peter Weber, Prof Dr med, +41 61 645 88 08, peter.weber@ukbb.ch
- Recruiting
Association Objectif Vaincre l'Autisme
Gland, Canton of Vaud, 1196
Charlotte Escané, MSc, +41 22 360 03 49, recherche@ovassocation.com
- Recruiting
University of Zurich, Department of Child and Adolescent Psychiatry
Zurich, 8032
Ronnie Gundelfinger, Dr. med., +41 44 499 26 26, ronnie.gundelfinger@puk.zh.ch
Nadja Studer, lic. phil., +41 44 499 26 26, nadja.studer@puk.zh.ch
About this study
This study aims to investigate the effectiveness of early (before the age of 5 years) and intensive intervention for children with Autism Spectrum Disorders.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Early intensive behavioral intervention, Early intensive eclectic intervention, Treatment as usual
- Keywords
- Early intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early intensive behavioral interventionBehavioural
at least 10 hours a week of early intensive behavioral intervention
Early intensive eclectic interventionBehavioural
at least 10 hours a week of early intensive eclectic intervention
Treatment as usualOther
receipt of any Intervention that is less intensive than 10 hours a week
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Diagnostic Observation Schedule-2 (ADOS-2)
Measures autism symptom severity
Measured: Annually up to 3 years
Secondary outcomes (8)
Positive Gain Scale
Parent questionnaire
Measured: Annually up to 3 years
General Positive Affect Scale
Parent questionnaire
Measured: Annually up to 3 years
Questionnaire on Resources and Stress
Parent questionnaire
Measured: Annually up to 3 years
Hospital anxiety and Depression scale
Parent questionnaire
Measured: Annually up to 3 years
Strengths and Difficulties Questionnaire
Parent questionnaire to assess siblings' behavior and potential secondary effects of the intensive Intervention delivered
Measured: Annually up to 3 years
Vineland Adaptive Behavior Scales II (VABS)
Parent interview; adaptive behavior
Measured: Annually up to 3 years
Snijders-Oomen nicht-verbaler Intelligenztest 2 1/2 - 7 (SON-R)
IQ measure
Measured: Annually up to 3 years
Wechsler Preschool and Primary Scale of Intelligence-III (WPPSI-III)
IQ measure
Measured: Annually if child is testable up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronnie Gundelfinger, Dr. med., Principal investigator, University of Zurich, Department of Child and Adolescent Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302911
- Sponsor's protocol ID
- SWEIPA
- Acronym
- SwissEIPA
- Status last verified
- Sep 2017
- First submitted
- 23 Oct 2014
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Early Intervention Project in Autism: An Evaluation of Early Intervention Outcome
- ClinicalTrials.gov ID
- NCT02302911
- Acronym / sponsor ID
- SwissEIPA / SWEIPA
- Conditions
- Autism Spectrum Disorder
- Keywords
- Early intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early intensive behavioral intervention | – | Behavioral: Early intensive behavioral interventionChildren 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. |
| Early intensive eclectic intervention | – | Behavioral: Early intensive eclectic interventionChildren with a diagnosis of Autism Spectrum Disorder under the age of 5 years that are receiving early intensive eclectic Intervention at the participating centre. |
| Control group | – | Other: Treatment as usualChildren with a diagnosis of Autism Spectrum Disorder under the age of 5 years that are receiving treatment as usual or no treatment at all. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early intensive behavioral interventionat least 10 hours a week of early intensive behavioral intervention | Behavioural | Early intensive behavioral intervention |
| Early intensive eclectic interventionat least 10 hours a week of early intensive eclectic intervention | Behavioural | Early intensive eclectic intervention |
| Treatment as usualreceipt of any Intervention that is less intensive than 10 hours a week | Other | Control group |
Primary outcome
Autism Diagnostic Observation Schedule-2 (ADOS-2)
Time frame: Annually up to 3 years
Measures autism symptom severity
8 secondary outcomes
Positive Gain Scale
Time frame: Annually up to 3 years
General Positive Affect Scale
Time frame: Annually up to 3 years
Questionnaire on Resources and Stress
Time frame: Annually up to 3 years
Hospital anxiety and Depression scale
Time frame: Annually up to 3 years
Strengths and Difficulties Questionnaire
Time frame: Annually up to 3 years
Vineland Adaptive Behavior Scales II (VABS)
Time frame: Annually up to 3 years
Snijders-Oomen nicht-verbaler Intelligenztest 2 1/2 - 7 (SON-R)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronnie Gundelfinger, Dr. med. principal investigator
University of Zurich, Department of Child and Adolescent Psychiatry
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by University of Zurich at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronnie Gundelfinger, Dr. med. (+41 44 499 26 26, ronnie.gundelfinger@puk.zh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Diagnostic Observation Schedule-2 (ADOS-2) (time frame: Annually up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.