NCT03196713

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2017

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

4.4 years

First QC Date

June 20, 2017

Last Update Submit

August 14, 2018

Conditions

Keywords

AllegianceKnowledgeSupervisionEarly interventionAutism

Outcome Measures

Primary Outcomes (1)

  • York Measure of Quality of Behavioural Intensive Intervention (YMQI)

    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)

    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)

Study Arms (2)

Tailored supervision

OTHER
Behavioral: Early Intensive Behavioral Intervention

Regular supervision

OTHER
Behavioral: Early Intensive Behavioral Intervention

Interventions

Also known as: Applied Behavior Analysis
Regular supervisionTailored supervision

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KIND, CAP Research Center

Stockholm, 11330, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 28691542BACKGROUND
  • 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.

    PMID: 27060473BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Interventions

Applied Behavior Analysis

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sven Bolte, Prof, PhD

    Karolinska Institutet, KBH, KIND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Pragmatic RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neuropsychiary Division, director of KIND, Professor, PhD

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 23, 2017

Study Start

April 1, 2013

Primary Completion

August 31, 2017

Study Completion

October 27, 2017

Last Updated

August 15, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations