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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04201509
Other study ID # 2012/88
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2011
Est. completion date November 1, 2019

Study information

Verified date December 2019
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date November 1, 2019
Est. primary completion date January 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden Pia Tallberg Lund Skane

Sponsors (2)

Lead Sponsor Collaborator
Region Skane Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Cognitive status assesses with the Weschsler Intelligence Scales for Children-Fourth Edition (WISC-IV) 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. 2011-2012 and 2014-2015
Primary Emotional status assessed with the Beck Youth Inventory. 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. 2011-2012 and 2014-2015
Secondary Neuropsychological status assesses with the Conners' Continuous Performance Test (CPT) II 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. 2011-2012 and 2014-2015
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