Validity of Neurocognitive Assessment Methods in Childhood ADHD

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.

Study Overview

• Status: Completed
• Conditions: 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

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• Sweden
  • Skane
    • Lund, Skane, Sweden, 22185
      • Pia Tallberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University
• Investigators: Principal Investigator: Peik Gustafsson, Dr, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Anxiety; Children; Attention; Follow-up; Intelligence; Conduct behavior
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Attention Deficit and Disruptive Behavior Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders
• Other Study ID Numbers: 2012/88

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No