Will early intensive behavioral training improve executive function in young children with autism spectrum disorder?
| ISRCTN | ISRCTN70290917 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70290917 |
| Secondary identifying numbers | 51533 |
- Submission date
- 22/12/2016
- Registration date
- 12/01/2017
- Last edited
- 20/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 2021
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
Contact information
Scientific
Division of habilitation and rehabilitation
Innlandet Hospital Trust
Maihaugvegen 4
Lillehammer
2609
Norway
| Phone | +47 61 05 92 50 |
|---|---|
| erik.winther.skogli@sykehuset-innlandet.no |
Study information
| Study design | Single-center non-randomised interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Behavior Rating Inventory of Executive Function (BRIEF) in a group of preschool children with autism spectrum disorder |
| Study acronym | BAUS |
| Study objectives | Early and Intensive Behavioral Intervention (EIBI) based early behavioral intervention will improve executive function in children with autism. |
| Ethics approval(s) | Data Protection Official/Officer, 16/12/2016, ref: 51533 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2016 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 6 Years |
| Sex | Both |
| Target number of participants | Minimum 30 participants |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Children diagnosed with an autism 2. Diagnosis from age 3 - 6 years |
| Key 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 |
| Date of first enrolment | 01/01/2017 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- Norway
Study participating centre
Maihaugvegen 4
Lillehammer
2609
Norway
Sponsor information
Hospital/treatment centre
Division of habilitation and rehabilitation
Innlandet Hospital Trust
Maihaugvegen 4
Lillehammer
2609
Norway
| Phone | +47 61 05 92 50 |
|---|---|
| erik.winther.skogli@sykehuset-innlandet.no | |
"ROR" |
https://ror.org/02kn5wf75 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/05/2020 | 20/06/2023 | Yes | No |
Editorial Notes
20/06/2023: Publication reference and total final enrolment added.
09/12/2020: The following changes have been made to the trial record:
1. The overall trial end date was changed from 31/12/2020 to 31/12/2021.
2. The intention to publish date was changed from 31/12/2021 to 31/12/2022.
17/01/2019: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 31/12/2018 to 31/12/2020
2. The intention to publish date has been changed from 01/04/2019 to 31/12/2021
