World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 4 July 2023
Main ID:  ISRCTN70290917
Date of registration: 12/01/2017
Prospective Registration: No
Primary sponsor: Innlandet Hopital Trust
Public title: Will early intensive behavioral training improve executive function in young children with autism spectrum disorder?
Scientific title: Behavior Rating Inventory of Executive Function (BRIEF) in a group of preschool children with autism spectrum disorder
Date of first enrolment: 01/01/2017
Target sample size: 30
Recruitment status: Completed
URL:  https://www.isrctn.com/ISRCTN70290917
Study type:  Interventional
Study design:  Single-center non-randomised interventional study (Treatment)  
Phase:  Not Applicable
Countries of recruitment
Norway
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Erik Winther    Skogli
Address:  Division of habilitation and rehabilitation Innlandet Hospital Trust Maihaugvegen 4 2609 Lillehammer Norway
Telephone: +47 61 05 92 50
Email: erik.winther.skogli@sykehuset-innlandet.no
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
1. Children diagnosed with an autism
2. Diagnosis from age 3 - 6 years

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


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Autism Spectrum Disorder (ASD)
Mental and Behavioural Disorders
Autism Spectrum Disorder (ASD)
Intervention(s)

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.
Primary Outcome(s)
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(s)

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
Secondary ID(s)
51533
Source(s) of Monetary Support
Division of habilitation and rehabilitation, Innlandet Hospital Trust
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Old ethics approval format; Data Protection Official/Officer, 16/12/2016, ref: 51533
Results
Results available: Yes
Date Posted:
Date Completed: 31/12/2021
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history