Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

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

Trial website

Contact information



Primary contact

Mr Erik Winther Skogli


Contact details

Division of habilitation and rehabilitation
Innlandet Hospital Trust
Maihaugvegen 4
+47 61 05 92 50

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Behavior Rating Inventory of Executive Function (BRIEF) in a group of preschool children with autism spectrum disorder



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


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Autism Spectrum Disorder (ASD)


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



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


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Children diagnosed with an autism
2. Diagnosis from age 3 - 6 years

Participant type


Age group




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


Recruitment end date



Countries of recruitment


Trial participating centre

Innlandet Hospital Trust
Division of habilitation and rehabilitation Maihaugvegen 4

Sponsor information


Innlandet Hopital Trust

Sponsor details

Division of habilitation and rehabilitation
Innlandet Hospital Trust
Maihaugvegen 4
+47 61 05 92 50

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Division of habilitation and rehabilitation, Innlandet Hospital Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes