Back to resultsEarly Intervention, Supervision, Quality and Outcome in ASD
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Early Intensive Behavioral Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Autism Spectrum Disorder focused on measuring Allegiance, Knowledge, Supervision, Early intervention, Autism
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ASD (ICD-10), ongoing EIBI program
Exclusion Criteria:
-
Sites / Locations
- KIND, CAP Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Tailored supervision
Regular supervision
Arm Description
Outcomes
Primary Outcome Measures
York Measure of Quality of Behavioural Intensive Intervention (YMQI)
Secondary Outcome Measures
Vineland Adaptive Behavior Scales (VABS)
Social Responsiveness Scale (SRS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03196713
Brief Title
Early Intervention, Supervision, Quality and Outcome in ASD
Official Title
Quality and Efficacy of Early Intensive Autism Intervention: a Matter of Trust, Knowledge, and Supervision?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2013 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
October 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Allegiance, Knowledge, Supervision, Early intervention, Autism
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic RCT
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tailored supervision
Arm Type
Other
Arm Title
Regular supervision
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Early Intensive Behavioral Intervention
Other Intervention Name(s)
Applied Behavior Analysis
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ASD (ICD-10), ongoing EIBI program
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Bolte, Prof, PhD
Organizational Affiliation
Karolinska Institutet, KBH, KIND
Official's Role
Principal Investigator
Facility Information:
Facility Name
KIND, CAP Research Center
City
Stockholm
ZIP/Postal Code
11330
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28691542
Citation
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.
Results Reference
background
PubMed Identifier
27060473
Citation
Langh 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.
Results Reference
background
Learn more about this trial
Early Intervention, Supervision, Quality and Outcome in ASD
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