NCT04946877

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

June 23, 2021

Last Update Submit

February 2, 2022

Conditions

Keywords

ADHD,comorbidities

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • determinate presence of soft neurological sign in children and adolescents with ADHD using Cambridge neurological inventory.

    baseline

Study Arms (2)

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)

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)

Interventions

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 .

Also known as: 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
case groupcontrol group

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 15322959BACKGROUND
  • 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.

    PMID: 27189265BACKGROUND
  • 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.

    PMID: 24942707BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

salma mohmed fahmi, msc

CONTACT

Ahmed Abdelbaky Abd elrahman, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 1, 2021

Study Start

March 1, 2022

Primary Completion

August 1, 2022

Study Completion

October 1, 2022

Last Updated

February 3, 2022

Record last verified: 2022-02