Clinical Study of Comorbidities of Attention Deficit Hyperactivity in Children and Adolescents.

Determine the frequency of psychiatric and neurological comorbidities in children and adolescence diagnosed with ADHD.

Study Overview

• Status: Not yet recruiting
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Diagnostic test: IQ assessment using Wechsler intelligence scale for children third edition (WISC-III)

Detailed Description

ADHD is a common neurodevelopmental disorder characterized by hyperactivity, impulsivity, and inattention .ADHD is more often a complex disorder with a high rate of associated co-morbid conditions. Co-morbid conditions are prevalent among people with ADHD and increase its burden and complexity of management.Children with ADHD are at a higher risk than children without ADHD for developing other psychiatric disorders .Motor skill problems and Neurological soft signs are found in many neuropsychiatric conditions .NSS have been associated with inattention and behaviour difficulties for decades. Some researchers argue that these signs should be included in the diagnosis of ADHD .

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: salma mohmed fahmi, msc; Phone Number: 01067151755; Email: saloma151@yahoo.com
• Study Contact Backup: Name: Ahmed Abdelbaky Abd elrahman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Case group will include 100 ADHD patients; will be taken from outpatient clinic of child and adolescence psychiatry of Assiut university hospitals.

Control group will include 100 normal children; they will be selected from neurology clinic complaining from minor neurological complaint e.g : headache, will match with the case group for age, sex and educational level.

Description

Inclusion Criteria:

• Age: 6-17 years.
• Sex: both sexes will be included in the study.
• IQ≥70.

Exclusion Criteria:

• Age: less than 6 years or more than 17 years.
• IQ<70.
• Patients with major neurological deficits, cerebral palsy and uncontrolled epilepsy.
• Patients with major psychiatric disorders e.g schizophrenia spectrum disorder.
• Patient who refusing to participate in the study or their caregiver refusing to give informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
case group; 100 ADHD patients; will be taken from outpatient clinic of child and adolescence psychiatry of Assiut university hospitals.	Diagnostic test: IQ assessment using Wechsler intelligence scale for children third edition (WISC-III); IQ assessment using Wechsler intelligence scale for children third edition (WISC-III): is consists of several subtests, each classified into a verbal or performance scale .; Other Names: Mini international neuropsychiatric interview for children and adolescents (M.I.N.I. Kid); Child behavior checklist (CBCL), parent form; Neurological assessment using Cambridge neurological inventory
control group; 100 normal children; they will be selected from neurology clinic complaining from minor neurological complaint e.g : headache, will match with the case group for age, sex and educational level.	Diagnostic test: IQ assessment using Wechsler intelligence scale for children third edition (WISC-III); IQ assessment using Wechsler intelligence scale for children third edition (WISC-III): is consists of several subtests, each classified into a verbal or performance scale .; Other Names: Mini international neuropsychiatric interview for children and adolescents (M.I.N.I. Kid); Child behavior checklist (CBCL), parent form; Neurological assessment using Cambridge neurological inventory

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine psychiatric comorbidities in children and adolescents with ADHD using Mini international neuropsychiatric interview for children and adolescents (M.I.N.I. Kid).	Mini international neuropsychiatric interview for children and adolescents (M.I.N.I. Kid): is structured clinical diagnostic interview designed to assess the presence of current ICD-10 and DSM-IV psychiatric disorders in children and adolescents age 6-17 years	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
determinate presence of soft neurological sign in children and adolescents with ADHD using Cambridge neurological inventory.	Neurological assessment using Cambridge neurological inventory: this is a clinical instrument constructed for standardized neurological assessment of psychiatric patients. It is useful for identifying neurological soft sign and other patterns of neurological impairments	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Gillberg C, Gillberg IC, Rasmussen P, Kadesjo B, Soderstrom H, Rastam M, Johnson M, Rothenberger A, Niklasson L. Co-existing disorders in ADHD -- implications for diagnosis and intervention. Eur Child Adolesc Psychiatry. 2004;13 Suppl 1:I80-92. doi: 10.1007/s00787-004-1008-4.
• Faraone SV, Asherson P, Banaschewski T, Biederman J, Buitelaar JK, Ramos-Quiroga JA, Rohde LA, Sonuga-Barke EJ, Tannock R, Franke B. Attention-deficit/hyperactivity disorder. Nat Rev Dis Primers. 2015 Aug 6;1:15020. doi: 10.1038/nrdp.2015.20.
• Jensen CM, Steinhausen HC. Comorbid mental disorders in children and adolescents with attention-deficit/hyperactivity disorder in a large nationwide study. Atten Defic Hyperact Disord. 2015 Mar;7(1):27-38. doi: 10.1007/s12402-014-0142-1. Epub 2014 Jun 19.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: ADHD,comorbidities
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: Comorbidities with ADHD

Drug and device information, study documents

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