Validity of Neurocognitive Assessment Methods in Childhood ADHD

NCT04201509 | Completed

• 1 other identifier: 2012/88
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Disorders; Attention Deficit Hyperactivity Disorder

Keywords

Intelligence; Anxiety; Attention; Conduct behavior; Follow-up; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neuropsychological status assesses with the Conners' Continuous Performance Test (CPT) II

  2011-2012 and 2014-2015

Other Outcomes (1)

• Cognitive status assesses with the Weschsler Intelligence Scales for Children-Fourth Edition (WISC-IV)

  2011-2012 and 2014-2015

Study Arms (2)

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.

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Pia Tallberg

Lund, Skåne County, 22185, Sweden

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Study Officials

• Peik Gustafsson, Dr

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 17, 2019
• Study Start: June 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: November 1, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)