Main
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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:
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ISRCTN |
Last refreshed on:
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4 July 2023 |
Main ID: |
ISRCTN70290917 |
Date of registration:
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12/01/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Will early intensive behavioral training improve executive function in young children with autism spectrum disorder?
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Scientific title:
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Behavior Rating Inventory of Executive Function (BRIEF) in a group of preschool children with autism spectrum disorder |
Date of first enrolment:
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01/01/2017 |
Target sample size:
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30 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN70290917 |
Study type:
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Interventional |
Study design:
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Single-center non-randomised interventional study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Norway
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Erik Winther
Skogli |
Address:
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Division of habilitation and rehabilitation
Innlandet Hospital Trust
Maihaugvegen 4
2609
Lillehammer
Norway |
Telephone:
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+47 61 05 92 50 |
Email:
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erik.winther.skogli@sykehuset-innlandet.no |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Autism Spectrum Disorder (ASD) Mental and Behavioural Disorders Autism Spectrum Disorder (ASD)
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Division of habilitation and rehabilitation, Innlandet Hospital Trust
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; Data Protection Official/Officer, 16/12/2016, ref: 51533
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/12/2021 |
URL:
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