Autism Spectrum DisorderNCT03196713
Early Intervention, Supervision, Quality and Outcome in ASD
A study testing Early Intensive Behavioral Intervention in people with Autism Spectrum Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The objective of this study is to examine the significance of knowledge of autism spectrum disorder (ASD), and early intensive behavioral intervention, as well as trust in EIBI, adequate assessment of EIBI quality, and EIBI supervision on EIBI intervention outcome in ASD. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Early Intensive Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2013to 27 Oct 2017
- Phase
- Interventional
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of ASD (ICD-10), ongoing EIBI program
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality and Efficacy of Early Intensive Autism Intervention: a Matter of Trust, Knowledge, and Supervision?
The objective of this study is to examine the significance of knowledge of autism spectrum disorder (ASD), and early intensive behavioral intervention, as well as trust in EIBI, adequate assessment of EIBI quality, and EIBI supervision on EIBI intervention outcome in ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Early Intensive Behavioral Intervention
- Keywords
- Allegiance, Knowledge, Supervision, Early intervention, Autism
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Intensive Behavioral InterventionBehavioural
Also called Applied Behavior Analysis
| Study group | Role | What they receive |
|---|---|---|
| Tailored supervision | Other | Not described Receives: Behavioral: Early Intensive Behavioral Intervention |
| Regular supervision | Other | Not described Receives: Behavioral: Early Intensive Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
York Measure of Quality of Behavioural Intensive Intervention (YMQI)
Measured: Change is assessed from baseline (probe 1) to probe 2 (2-3 months), and probe 3 (4-6 months)
Secondary outcomes (2)
Vineland Adaptive Behavior Scales (VABS)
Measured: Change is assessed from baseline (probe 1) to probe 2 (2-3 months), and probe 3 (4-6 months)
Social Responsiveness Scale (SRS)
Measured: Change is assessed from baseline (probe 1) to probe 2 (2-3 months), and probe 3 (4-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start1 Apr 2013
- Primary completion31 Aug 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Bölte, Karolinska Institutet
- Investigators
- Sven Bolte, Prof, PhD, Principal investigator, Karolinska Institutet, KBH, KIND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196713
- Sponsor's protocol ID
- EIBI Quality
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2017
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langh U, Cauvet E, Hammar M, Bolte S. Cross-Cultural Validation of the York Measure of Quality of Intensive Behavioral Intervention. Behav Modif. 2017 Nov;41(6):808-828. doi: 10.1177/0145445517719397. Epub 2017 Jul 9.
PubMed 28691542Langh U, Hammar M, Klintwall L, Bolte S. Allegiance and knowledge levels of professionals working with early intensive behavioural intervention in autism. Early Interv Psychiatry. 2017 Oct;11(5):444-450. doi: 10.1111/eip.12335. Epub 2016 Apr 6.
PubMed 27060473
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality and Efficacy of Early Intensive Autism Intervention: a Matter of Trust, Knowledge, and Supervision?
- ClinicalTrials.gov ID
- NCT03196713
- Acronym / sponsor ID
- EIBI Quality
- Conditions
- Autism Spectrum Disorder
- Keywords
- Allegiance, Knowledge, Supervision, Early intervention, Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 23 Jun 2017 (actual)
- 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.
The objective of this study is to examine the significance of knowledge of autism spectrum disorder (ASD), and early intensive behavioral intervention, as well as trust in EIBI, adequate assessment of EIBI quality, and EIBI supervision on EIBI intervention outcome in ASD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic RCT
| Arm | Type | Receives |
|---|---|---|
| Tailored supervision | Other | Behavioral: Early Intensive Behavioral Intervention |
| Regular supervision | Other | Behavioral: Early Intensive Behavioral Intervention |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of ASD (ICD-10), ongoing EIBI program
Key exclusion criteria (1 listed)
- -
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 InterventionAlso: Applied Behavior Analysis | Behavioural | Regular supervision, Tailored supervision |
Primary outcome
York Measure of Quality of Behavioural Intensive Intervention (YMQI)
Time frame: Change is assessed from baseline (probe 1) to probe 2 (2-3 months), and probe 3 (4-6 months)
2 secondary outcomes
Vineland Adaptive Behavior Scales (VABS)
Time frame: Change is assessed from baseline (probe 1) to probe 2 (2-3 months), and probe 3 (4-6 months)
Social Responsiveness Scale (SRS)
Time frame: Change is assessed from baseline (probe 1) to probe 2 (2-3 months), and probe 3 (4-6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Background: PubMed 28691542Langh U, Cauvet E, Hammar M, Bolte S. Cross-Cultural Validation of the York Measure of Quality of Intensive Behavioral Intervention. Behav Modif. 2017 Nov;41(6):808-828. doi: 10.1177/0145445517719397. Epub 2017 Jul 9.
- Background: PubMed 27060473Langh U, Hammar M, Klintwall L, Bolte S. Allegiance and knowledge levels of professionals working with early intensive behavioural intervention in autism. Early Interv Psychiatry. 2017 Oct;11(5):444-450. doi: 10.1111/eip.12335. Epub 2016 Apr 6.
- Individual participant dataSharing planned: No
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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.
Sven Bolte, Prof, PhD principal investigator
Karolinska Institutet, KBH, KIND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Intensive Behavioral Intervention in people with Autism Spectrum Disorder, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
York Measure of Quality of Behavioural Intensive Intervention (YMQI) (time frame: Change is assessed from baseline (probe 1) to probe 2 (2-3 months), and probe 3 (4-6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03196713, which also lists 2 linked publications.
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 15 Aug 2018.