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Clinical Trials/NCT03196713
NCT03196713CompletedNot Applicable

Quality and Efficacy of Early Intensive Autism Intervention: a Matter of Trust, Knowledge, and Supervision?

Karolinska Institutet2 sites in 1 country34 target enrollmentStarted: April 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
2
Primary Endpoint
York Measure of Quality of Behavioural Intensive Intervention (YMQI)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Tailored supervision

Other

Intervention: Early Intensive Behavioral Intervention (Behavioral)

Regular supervision

Other

Intervention: Early Intensive Behavioral Intervention (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • Vineland Adaptive Behavior Scales (VABS)(Change is assessed from baseline (probe 1) to probe 2 (2-3 months), and probe 3 (4-6 months))
  • Social Responsiveness Scale (SRS)(Change is assessed from baseline (probe 1) to probe 2 (2-3 months), and probe 3 (4-6 months))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sven Bölte

Head of Neuropsychiary Division, director of KIND, Professor, PhD

Karolinska Institutet

Study Sites (2)

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