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Early Intervention, Supervision, Quality and Outcome in ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03196713
Recruitment Status : Completed
First Posted : June 23, 2017
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Sven Bölte, Karolinska Institutet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Early Intensive Behavioral Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic RCT
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Quality and Efficacy of Early Intensive Autism Intervention: a Matter of Trust, Knowledge, and Supervision?
Actual Study Start Date : April 1, 2013
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : October 27, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Tailored supervision Behavioral: Early Intensive Behavioral Intervention
Other Name: Applied Behavior Analysis
Regular supervision Behavioral: Early Intensive Behavioral Intervention
Other Name: Applied Behavior Analysis


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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) ]
  2. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ASD (ICD-10), ongoing EIBI program

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196713


Locations
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Sweden
KIND, CAP Research Center
Stockholm, Sweden, 11330
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Sven Bolte, Prof, PhD Karolinska Institutet, KBH, KIND
More Information
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Publications:

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Responsible Party: Sven Bölte, Head of Neuropsychiary Division, director of KIND, Professor, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03196713    
Other Study ID Numbers: EIBI Quality
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sven Bölte, Karolinska Institutet:
Allegiance
Knowledge
Supervision
Early intervention
Autism
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders