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Validity of Neurocognitive Assessment Methods in Childhood ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04201509
Recruitment Status : Completed
First Posted : December 17, 2019
Last Update Posted : December 20, 2019
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Region Skane

Brief Summary:
The aim of the study is to examine the prospective validity of neurocognitive functions and emotional factors in schoolchildren with ADHD and a control group of typically developing schoolchildren at baseline and after three years.

Condition or disease
Neurodevelopmental Disorders Attention Deficit Hyperactivity Disorder

Detailed Description:

In spite of extensive research on children with ADHD, there is still insufficient understanding of the discriminative validity of neurocognitive tests and how test results of neurocognitive functions and ratings of emotional factors and ADHD symptoms change over time and interacts during development. The project is studying the validity of clinical assessment methods within the Swedish child and adolescent psychiatry service (CAP) related to the identification of ADHD, additional impairments, and comorbidity. The prospective validity of neurocognitive functions and emotional factors in schoolchildren with ADHD and a control group of typically developing schoolchildren at baseline and after three years will be investigated.

Specific aims: Aim I: Study how attentiveness and impulsivity in ADHD change over three years by comparing the results of psychological tests and rating scales at baseline and after three years Aim II: Study intellectual development in ADHD by comparing the results of intelligence tests at baseline and after three years- Aim III: Study how emotional factors change over three years by comparing the results of rating scales at baseline and after three years

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Study Type : Observational
Actual Enrollment : 196 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validity of Neurocognitive Assessment Methods in Childhood ADHD
Actual Study Start Date : June 1, 2011
Actual Primary Completion Date : January 1, 2016
Actual Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
ADHD group
Participants in the clinical group were recruited to the project when they were assessed for and diagnosed with ADHD at the Neuropsychiatric Unit of the CAP Clinic in Lund in 2011-2012. The ADHD group was treated as usual in the clinic and re-assessed during 2014-2015.
Non-clinical group
Participants in the non-clinical group were recruited recruited 2012 from schools in the same district and among children of the same average age as the ADHD-group 2012. The non-clinical group did not have any intervention during the follow-up time. Th non-clinical group was re-assessed during 2015.



Primary Outcome Measures :
  1. Emotional status assessed with the Beck Youth Inventory. [ Time Frame: 2011-2012 and 2014-2015 ]
    The children were assessed with the Beck youth scales at two timepoints with a time interval of 3 years. Beck Youth Inventory consist of 5 subscales, Depression, Anxiety, Anger, Disruptive behaviour, Self-concept. It is standardized into percentiles and higher scores mean worse behaviour, except for Self-concept. In Self-concept higher scores mean better behaviour.


Secondary Outcome Measures :
  1. Neuropsychological status assesses with the Conners' Continuous Performance Test (CPT) II [ Time Frame: 2011-2012 and 2014-2015 ]
    The children were assessed with the Conners'CPT II at two timepoints with a time interval of 3 years. Conners' CPT II is a performance based test measuring reaction time, reaction time variability, omissions and comissions. Conners' CPT II is standardised into T scores; mean=50, SD=10. Higher scores mean worse results.


Other Outcome Measures:
  1. Cognitive status assesses with the Weschsler Intelligence Scales for Children-Fourth Edition (WISC-IV) [ Time Frame: 2011-2012 and 2014-2015 ]
    The children were assessed with the WISC-IV at two timepoints with a time interval of 3 years. The WISC-IV is a performance based test, measuring cognitive functioning. The WISC-IV consists of 10 core subtests, that form four composites (Verbal Comprehension, Perceptual Reasoning, Working Memory, Processing Speed) and Full Scale IQ. The WISC-IV is standardised into the IQ scale, mean=100, SD=15. Higher scores mean better results.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children diagnosed with ADHD at the Neuropsychiatric Unit of the CAP Clinic in Lund in 2011-2012, 7 to 18 years old when recrutited to the study. School children from Lund, 7 to 18 years old when recrutited to the study.
Criteria

Inclusion Criteria: The ADHD-group:

• The individuals were assessed and diagnosed with ADHD at the Neuropsychiatric Unit of the CAP Clinic in Lund in 2011-2012

Non-clinical group:

  • School children from Lund.

Exclusion Criteria:

  • If the individual had a diagnosed intellectual disability
  • If the individual required an interpreter to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04201509


Locations
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Sweden
Pia Tallberg
Lund, Skane, Sweden, 22185
Sponsors and Collaborators
Region Skane
Lund University
Investigators
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Principal Investigator: Peik Gustafsson, Dr Lund University

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT04201509    
Other Study ID Numbers: 2012/88
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Skane:
Intelligence
Anxiety
Attention
Conduct behavior
Follow-up
Children
Additional relevant MeSH terms:
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Disease
Attention Deficit Disorder with Hyperactivity
Neurodevelopmental Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders