Condition category
Mental and Behavioural Disorders
Date applied
22/12/2016
Date assigned
12/01/2017
Last edited
12/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

31/12/2018

Reason abandoned

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

01/04/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes