Plain English Summary
Background and study aims
Autism Spectrum Disorder (ASD) is a common disorder that affects the way that a person communicates and relates to others. It is a spectrum condition the level of disability is spread across a wide range, from almost unnoticeable to completely debilitating. In general the symptoms involve problems with social communication (speech and body language), social interaction (recognising and expressing emotions) and social imagination (being able to understand and predict other people’s behaviour). It has also been found that people with ASD often experience problems with executive function (the management of mental processes such as working memory, reasoning, flexibility, and problem solving as well as planning and execution). There is a growing body of evidence that an intensive behavioral treatment program (intensive behavioural interventions) can lead to significant improvement in the functioning of young children with ASD. Early Intensive Behavioral Interventions (EIBI) are programs where this treatment is initiated early. They have been reported to be effective in improving socially significant behaviors to a meaningful degree. The aim of this study is to find out whether an EIBI can help improve executive function in children with autism.
Who can participate?
Children aged between three and six who have been diagnosed with autism.
What does the study involve?
All participants take part in the EIBI. This involves behavioral training from 30 to 40 hours per week, primarily in the kindergarten. The kindergarten teachers are trained to deliver the program and supervised closely by experienced clinicians. Children complete a number of assessments to measure their level of executive functioning at the start of the study and then after six and 12 months. At the start of the study, their IQ is also assessed so that this can be compared to the changes (if any) in executive function.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in their behaviour. There are no notable risks involved with participating.
Where is the study run from?
Innlandet Hospital Trust (Norway)
When is the study starting and how long is it expected to run for?
October 2016 to December 2018
Who is funding the study?
Division of habilitation and rehabilitation, Innlandet Hospital Trust (Norway)
Who is the main contact?
Dr Erik Winther Skogli
erik.winther.skogli@sykehuset-innlandet.no
Trial website
Contact information
Type
Scientific
Primary contact
Mr Erik Winther Skogli
ORCID ID
Contact details
Division of habilitation and rehabilitation
Innlandet Hospital Trust
Maihaugvegen 4
Lillehammer
2609
Norway
+47 61 05 92 50
erik.winther.skogli@sykehuset-innlandet.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
51533
Study information
Scientific title
Behavior Rating Inventory of Executive Function (BRIEF) in a group of preschool children with autism spectrum disorder
Acronym
BAUS
Study hypothesis
Early and Intensive Behavioral Intervention (EIBI) based early behavioral intervention will improve executive function in children with autism.
Ethics approval
Data Protection Official/Officer, 16/12/2016, ref: 51533
Study design
Single-center non-randomised interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Autism Spectrum Disorder (ASD)
Intervention
Following provision of parental informed consent, all children undergo a clinical assessment featuring a structured diagnostic interview (Autism Diagnostic Interview – Revised), a diagnostic observation schedule (ADOS-2), neuropsychological assessment and a medical examination.
Children receiving an ASD diagnosis will be offered an intensive behavioral intervention based upon the principles of applied behavior analysis (EIBI). This intervention method involves behavioral training from 30 to 40 hours per week, primarily in the kindergarten of these children. The kindergarten teachers will be trained and supervised closely by experienced clinicians at Division of Habilitation and Rehabilitation, Innlandet Hospital Trust. The intervention period will last from 6 to 24 months depending on the age of children at baseline. The effect of intervention will be evaluated with the BRIEF after 6 months, 12 months (at the end of intervention) and 12 months after intervention have been terminated.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Executive function is measured using the Behavior Rating Inventory of Executive Function (BRIEF) and the Behavior Rating Inventory of Executive Function - preschool Version (BRIEF-P) at baseline, after 6 months and 12 months.
Secondary outcome measures
1. IQ is measured using the Wechsler Preschool and Primary Scale of Intelligence – Fourth Edition (WPPSI-IV) and the Wechsler Intelligence Scale for Children - Fourth edition (WISC-IV) at baseline
2. Non-verbal IQ is measured using the Leiter International Performance Scale- Revised (Leiter-R) at baseline
Overall trial start date
01/10/2016
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children diagnosed with an autism
2. Diagnosis from age 3 - 6 years
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Minimum 30 participants
Participant exclusion criteria
1. IQ below 49
2. Subjects born prematurely (< 36 weeks)
3. Taking medication for the disorder they are referred for at the time of inclusion
Recruitment start date
01/01/2017
Recruitment end date
31/12/2018
Locations
Countries of recruitment
Norway
Trial participating centre
Innlandet Hospital Trust
Division of habilitation and rehabilitation
Maihaugvegen 4
Lillehammer
2609
Norway
Sponsor information
Organisation
Innlandet Hopital Trust
Sponsor details
Division of habilitation and rehabilitation
Innlandet Hospital Trust
Maihaugvegen 4
Lillehammer
2609
Norway
+47 61 05 92 50
erik.winther.skogli@sykehuset-innlandet.no
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Division of habilitation and rehabilitation, Innlandet Hospital Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
At least two publications in scientific journals are planned.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from erik.winther.skogli@sykehuset-innlandet.no
Intention to publish date
31/12/2021
Participant level data
Available on request
Basic results (scientific)
Publication list