Attention Deficit Hyperactivity DisorderNCT04946877
Clinical Study of Comorbidities of Attention Deficit Hyperactivity in Children and Adolescents.
An observational study of Attention Deficit Hyperactivity Disorder, run by Assiut University.
Trial summary
Determine the frequency of psychiatric and neurological comorbidities in children and adolescence diagnosed with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- IQ assessment using Wechsler intelligence scale for children third edition (WISC-III)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Child
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.
Who may be able to join
- Age: 6-17 years.
- Sex: both sexes will be included in the study.
- IQ≥70.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Ahmed Abdelbaky Abd elrahman, MD contact
About this study
Determine the frequency of psychiatric and neurological comorbidities in children and adolescence diagnosed with ADHD.
Read the 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 .
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- IQ assessment using Wechsler intelligence scale for children third edition (WISC-III)
- Keywords
- ADHD,comorbidities
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQ assessment using Wechsler intelligence scale for children third edition (WISC-III)Diagnostic test
Also called 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
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 .
| Study group | Role | What they receive |
|---|---|---|
| case group | 100 ADHD patients; will be taken from outpatient clinic of child and adolescence psychiatry of Assiut university hospitals. Receives: 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. Receives: Diagnostic Test: IQ assessment using Wechsler intelligence scale for children third edition (WISC-III) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (1)
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Mar 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Mohmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946877
- Sponsor's protocol ID
- Comorbidities with ADHD
- Status last verified
- Feb 2022
- First submitted
- 23 Jun 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 15322959Faraone 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.
PubMed 27189265Jensen 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.
PubMed 24942707
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Comorbidities of Attention Deficit Hyperactivity in Children and Adolescents.
- ClinicalTrials.gov ID
- NCT04946877
- Acronym / sponsor ID
- Comorbidities with ADHD
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD,comorbidities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the frequency of psychiatric and neurological comorbidities in children and adolescence diagnosed with ADHD.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: IQ assessment using Wechsler intelligence scale for children third edition (WISC-III)100 ADHD patients; will be taken from outpatient clinic of child and adolescence psychiatry of Assiut university hospitals. |
| control group | – | Diagnostic Test: IQ assessment using Wechsler intelligence scale for children third edition (WISC-III)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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Age: 6-17 years.
- Sex: both sexes will be included in the study.
- IQ≥70.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQ assessment using Wechsler intelligence scale for children third edition (WISC-III)Also: Mini international neuropsychiatric interview for children and adolescents (M.I.N.I. Kid), Child behavior checklist (CBCL), parent form, Neurological assessment using Cambridge neurological inventoryIQ assessment using Wechsler intelligence scale for children third edition (WISC-III): is consists of several subtests, each classified into a verbal or performance scale . | Diagnostic test | case group, control group |
Primary outcome
Determine psychiatric comorbidities in children and adolescents with ADHD using Mini international neuropsychiatric interview for children and adolescents (M.I.N.I. Kid).
Time frame: baseline
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
1 secondary outcome
determinate presence of soft neurological sign in children and adolescents with ADHD using Cambridge neurological inventory.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Background: PubMed 15322959Gillberg 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.
- Background: PubMed 27189265Faraone 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.
- Background: PubMed 24942707Jensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Abdelbaky Abd elrahman, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact salma mohmed fahmi, msc (01067151755, saloma151@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine psychiatric comorbidities in children and adolescents with ADHD using Mini international neuropsychiatric interview for children and adolescents (M.I.N.I. Kid). (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04946877, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.