ADHDNCT06146595
Prevalence of Attention Deficit Hyperactivity Disorder and Its Comorbidities
An observational study of ADHD, run by Assiut University.
Trial summary
Estimate the prevalence of attention deficit hyperactivity disorder and comorbid psychiatric disorder among primary school students in New Valley governorate. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Nov 2025
- How long will I take part?
- 2 Years
- 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
- Healthy volunteers accepted
- Child
Study population: primary school students in New Valley governorate
Who may be able to join
- Age: 6-17 years. Sex: both sexes will be included in the study.
Who cannot join
- Age: less than 6 years or more than 17 years. Patients with major neurological deficits, cerebral palsy. Patient who refusing to participate in the study or their caregiver refusing to give informed consent. Mentally retarded children.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence Study of Attention Deficit Hyperactivity Disorder and Its Comorbidities Among a Sample of Primary School Students in New Valley Governorate
Estimate the prevalence of attention deficit hyperactivity disorder and comorbid psychiatric disorder among primary school students in New Valley governorate.
Read the detailed description
ADHD (attention deficit hyperactivity disorder) is a common neurodevelopmental disorder characterized by hyperactivity, impulsivity, and inattention. Its prevalence ranges between 5.9 and 7.1% worldwide. Etiology of ADHD included combinations of genetic, neurological, and environmental factors. ADHD is more often a complex disorder with a high rate of associated comorbid conditions. Comorbid 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. Most children with ADHD also have at least one comorbid condition, the presence of which contributes to poorer long-term outcomes. The pattern of comorbidities is influenced by age and sex; externalizing disorders are more common in younger ages and male participants, in contrast, internalizing disorders are more prevalent among older ages and female participants. Comorbidity involving ADHD and learning disorders is frequent, ranging from 25 to 40%. Other disorders likely to co-occur with ADHD are: bipolar disorders (11-75%), tic disorders (20%), obsessive compulsive disorders (6-15%). Children with ADHD may show several motor problems: longer and more variable reaction times, increased variability in speed and less accurate response reengagement, and impaired orienting responses, and increased number of responses with very long reaction times. Neurological soft sign have been associated with inattention and behavior difficulties for decades. Some researchers argue that these signs should be included in the diagnosis of ADHD.
- Conditions
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect the prevalence of attention deficit hyperactivity disorder among primary school students in New Valley governorate
the child and his parents will be subjected to special psychiatric interview sheet designed at child psychiatric unit at Assiut university hospital for collecting detailed psychiatric history of the child and assessment of the child through a detailed interview including mental state examination and neurological examination.also the child will be subjected to Conner's Parent Rating Scale-revised (L).
Measured: Baseline
Secondary outcomes (1)
Detect comorbid psychiatric disorder among ADHD primary school student in New Valley governorate.
the child will be subjected to Child behavior checklist (CBCL), parent form
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmood Mohammed Yosry Abdelsatar Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146595
- Sponsor's protocol ID
- ADHD and its comorbidity
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Belanger SA, Andrews D, Gray C, Korczak D. ADHD in children and youth: Part 1-Etiology, diagnosis, and comorbidity. Paediatr Child Health. 2018 Nov;23(7):447-453. doi: 10.1093/pch/pxy109. Epub 2018 Oct 24.
PubMed 30681669Willcutt EG. The prevalence of DSM-IV attention-deficit/hyperactivity disorder: a meta-analytic review. Neurotherapeutics. 2012 Jul;9(3):490-9. doi: 10.1007/s13311-012-0135-8.
PubMed 22976615Becker SP, Langberg JM, Evans SW. Sleep problems predict comorbid externalizing behaviors and depression in young adolescents with attention-deficit/hyperactivity disorder. Eur Child Adolesc Psychiatry. 2015 Aug;24(8):897-907. doi: 10.1007/s00787-014-0636-6. Epub 2014 Oct 31.
PubMed 25359419Mohammadi MR, Zarafshan H, Khaleghi A, Ahmadi N, Hooshyari Z, Mostafavi SA, Ahmadi A, Alavi SS, Shakiba A, Salmanian M. Prevalence of ADHD and Its Comorbidities in a Population-Based Sample. J Atten Disord. 2021 Jun;25(8):1058-1067. doi: 10.1177/1087054719886372. Epub 2019 Dec 13.
PubMed 31833803Tung I, Li JJ, Meza JI, Jezior KL, Kianmahd JS, Hentschel PG, O'Neil PM, Lee SS. Patterns of Comorbidity Among Girls With ADHD: A Meta-analysis. Pediatrics. 2016 Oct;138(4):e20160430. doi: 10.1542/peds.2016-0430. Epub 2016 Sep 21.
PubMed 27694280Yoshimasu K, Barbaresi WJ, Colligan RC, Voigt RG, Killian JM, Weaver AL, Katusic SK. Childhood ADHD is strongly associated with a broad range of psychiatric disorders during adolescence: a population-based birth cohort study. J Child Psychol Psychiatry. 2012 Oct;53(10):1036-43. doi: 10.1111/j.1469-7610.2012.02567.x. Epub 2012 May 31.
PubMed 22647074Gillberg 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 15322959Cardo E, Casanovas S, de la Banda G, Servera M. [Soft neurological signs: are they of any value in the assessment and diagnosis of attention deficit hyperactivity disorder?]. Rev Neurol. 2008;46 Suppl 1:S51-4. Spanish.
PubMed 18302123Johansen EB, Aase H, Meyer A, Sagvolden T. Attention-deficit/hyperactivity disorder (ADHD) behaviour explained by dysfunctioning reinforcement and extinction processes. Behav Brain Res. 2002 Mar 10;130(1-2):37-45. doi: 10.1016/s0166-4328(01)00434-x.
PubMed 11864716Spencer TJ, Biederman J, Mick E. Attention-deficit/hyperactivity disorder: diagnosis, lifespan, comorbidities, and neurobiology. J Pediatr Psychol. 2007 Jul;32(6):631-42. doi: 10.1093/jpepsy/jsm005. Epub 2007 Jun 7.
PubMed 17556405Jensen 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 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Study of Attention Deficit Hyperactivity Disorder and Its Comorbidities Among a Sample of Primary School Students in New Valley Governorate
- ClinicalTrials.gov ID
- NCT06146595
- Acronym / sponsor ID
- ADHD and its comorbidity
- Conditions
- ADHD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 24 Nov 2023 (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.
Estimate the prevalence of attention deficit hyperactivity disorder and comorbid psychiatric disorder among primary school students in New Valley governorate.
Detailed description
ADHD (attention deficit hyperactivity disorder) is a common neurodevelopmental disorder characterized by hyperactivity, impulsivity, and inattention. Its prevalence ranges between 5.9 and 7.1% worldwide. Etiology of ADHD included combinations of genetic, neurological, and environmental factors. ADHD is more often a complex disorder with a high rate of associated comorbid conditions. Comorbid 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. Most children with ADHD also have at least one comorbid condition, the presence of which contributes to poorer long-term outcomes. The pattern of comorbidities is influenced by age and sex; externalizing disorders are more common in younger ages and male participants, in contrast, internalizing disorders are more prevalent among older ages and female participants. Comorbidity involving ADHD and learning disorders is frequent, ranging from 25 to 40%. Other disorders likely to co-occur with ADHD are: bipolar disorders (11-75%), tic disorders (20%), obsessive compulsive disorders (6-15%). Children with ADHD may show several motor problems: longer and more variable reaction times, increased variability in speed and less accurate response reengagement, and impaired orienting responses, and increased number of responses with very long reaction times. Neurological soft sign have been associated with inattention and behavior difficulties for decades. Some researchers argue that these signs should be included in the diagnosis of ADHD.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- primary school students in New Valley governorate
Key inclusion criteria (1 listed)
- Age: 6-17 years. Sex: both sexes will be included in the study.
Key exclusion criteria (1 listed)
- Age: less than 6 years or more than 17 years. Patients with major neurological deficits, cerebral palsy. Patient who refusing to participate in the study or their caregiver refusing to give informed consent. Mentally retarded children.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detect the prevalence of attention deficit hyperactivity disorder among primary school students in New Valley governorate
Time frame: Baseline
the child and his parents will be subjected to special psychiatric interview sheet designed at child psychiatric unit at Assiut university hospital for collecting detailed psychiatric history of the child and assessment of the child through a detailed interview including mental state examination and neurological examination.also the child will be subjected to Conner's Parent Rating Scale-revised (L).
1 secondary outcome
Detect comorbid psychiatric disorder among ADHD primary school student in New Valley governorate.
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 24 Nov 2023.
- Results publication: PubMed 30681669Belanger SA, Andrews D, Gray C, Korczak D. ADHD in children and youth: Part 1-Etiology, diagnosis, and comorbidity. Paediatr Child Health. 2018 Nov;23(7):447-453. doi: 10.1093/pch/pxy109. Epub 2018 Oct 24.
- Results publication: PubMed 22976615Willcutt EG. The prevalence of DSM-IV attention-deficit/hyperactivity disorder: a meta-analytic review. Neurotherapeutics. 2012 Jul;9(3):490-9. doi: 10.1007/s13311-012-0135-8.
- Results publication: PubMed 25359419Becker SP, Langberg JM, Evans SW. Sleep problems predict comorbid externalizing behaviors and depression in young adolescents with attention-deficit/hyperactivity disorder. Eur Child Adolesc Psychiatry. 2015 Aug;24(8):897-907. doi: 10.1007/s00787-014-0636-6. Epub 2014 Oct 31.
- Results publication: PubMed 31833803Mohammadi MR, Zarafshan H, Khaleghi A, Ahmadi N, Hooshyari Z, Mostafavi SA, Ahmadi A, Alavi SS, Shakiba A, Salmanian M. Prevalence of ADHD and Its Comorbidities in a Population-Based Sample. J Atten Disord. 2021 Jun;25(8):1058-1067. doi: 10.1177/1087054719886372. Epub 2019 Dec 13.
- Results publication: PubMed 27694280Tung I, Li JJ, Meza JI, Jezior KL, Kianmahd JS, Hentschel PG, O'Neil PM, Lee SS. Patterns of Comorbidity Among Girls With ADHD: A Meta-analysis. Pediatrics. 2016 Oct;138(4):e20160430. doi: 10.1542/peds.2016-0430. Epub 2016 Sep 21.
- Results publication: PubMed 22647074Yoshimasu K, Barbaresi WJ, Colligan RC, Voigt RG, Killian JM, Weaver AL, Katusic SK. Childhood ADHD is strongly associated with a broad range of psychiatric disorders during adolescence: a population-based birth cohort study. J Child Psychol Psychiatry. 2012 Oct;53(10):1036-43. doi: 10.1111/j.1469-7610.2012.02567.x. Epub 2012 May 31.
- Results publication: 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.
- Results publication: PubMed 18302123Cardo E, Casanovas S, de la Banda G, Servera M. [Soft neurological signs: are they of any value in the assessment and diagnosis of attention deficit hyperactivity disorder?]. Rev Neurol. 2008;46 Suppl 1:S51-4. Spanish.
- Results publication: PubMed 11864716Johansen EB, Aase H, Meyer A, Sagvolden T. Attention-deficit/hyperactivity disorder (ADHD) behaviour explained by dysfunctioning reinforcement and extinction processes. Behav Brain Res. 2002 Mar 10;130(1-2):37-45. doi: 10.1016/s0166-4328(01)00434-x.
- Results publication: PubMed 17556405Spencer TJ, Biederman J, Mick E. Attention-deficit/hyperactivity disorder: diagnosis, lifespan, comorbidities, and neurobiology. J Pediatr Psychol. 2007 Jul;32(6):631-42. doi: 10.1093/jpepsy/jsm005. Epub 2007 Jun 7.
- Results publication: 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.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, 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 1 inclusion and 1 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 24 Nov 2023. 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 Mahmoud Mohamed, assistant lecturer (00201099636567, sirdabash1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the prevalence of attention deficit hyperactivity disorder among primary school students in New Valley governorate (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 NCT06146595, which also lists 11 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 24 Nov 2023.