Child Behavior DisordersNCT04745819
Epidemiological Screening of Psychiatric Disorders Among School Aged Children and Adolescent in Assiut Governorate
An observational study of Child Behavior Disorders and Child Mental Disorder, run by Assiut University at 1 site in Egypt.
Trial summary
Paediatric behavioural, developmental, and mental health issues are more common than childhood cancers, cardiac problems, and renal problems combined. Behavioural problems have often been conceptualized along two broad spectrums: internalizing problems which are expressed in intrapersonal manifestation, such as… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior Disorders, Child Mental Disorder, Adolescent Behaviour
- What is being tested?
- 1. The Child Behavior Checklist (CBCL), parent form
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2021to Feb 2023
- How long will I take part?
- 6 Months
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This is study will take part in the first screening phase in the Assiut government school community study. The other part will be in the child and adolescent psychiatry clinic at Neurology and Psychiatry department at Assiut university hospital.
Who may be able to join
- age of children (6-18 years)
- both males and females.
- have education in school at Assiut government.
Who cannot join
- 1- unwilling parent to recruited in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Paediatric behavioural, developmental, and mental health issues are more common than childhood cancers, cardiac problems, and renal problems combined.
Behavioural problems have often been conceptualized along two broad spectrums: internalizing problems which are expressed in intrapersonal manifestation, such as anxiety, depression, and withdrawal; and externalizing problems which are demonstrated in interpersonal manifestation, such as hyperactivity and aggression The lack of attention to the mental health of children and adolescents may lead to mental disorders with lifelong consequences, undermines compliance with health regimens, and reduces the capacity of societies to be safe and productive. As, children and adolescent mental health problems often have serious long term debilitating effects . Early identification and treatment of these problems are in the best interest of children, adolescents, their families, and society as a whole . All three essential ways in which epidemiology can contribute to our understanding of children and adolescent mental health: community burden, measurement, and triage were of utmost importance. planning and conducting the survey.
In this study the researchers will present the first large-scale survey of child and adolescent psychiatric disorders at Assiut government For adequate planning of services, including evidence-based mental health prevention and intervention, a population-representative survey of children and adolescent estimating mental disorders was urgently needed
- Being tested
- 1. The Child Behavior Checklist (CBCL), parent form
- Keywords
- child, adolescent, psychiatry
- Medical subject headings
- Child Behavior Disorders, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. The Child Behavior Checklist (CBCL), parent formBehavioural
It consists of 113 items; the parents complete it to detect emotional and behavioural problems in children and adolescents aged 6 to 18 years. It is scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). The time duration for item responses is the past six months.
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the prevalence of DSM 5 psychiatric disorders in the community sample of school children in Assiut government.
Measured: through study completion, an average of 1 year
measure of risk factor of DSM 5 psychiatric disorders in the community sample of school children in Assiut government.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior DisordersStudies 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
- Cross-sectional
- Enrolment
- 400 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gellan Karamalllah Ramadan Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745819
- Sponsor's protocol ID
- epidemyology study in Assiut
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Screening of Psychiatric Disorders Among School Aged Children and Adolescent in Assiut Governorate
- ClinicalTrials.gov ID
- NCT04745819
- Acronym / sponsor ID
- epidemyology study in Assiut
- Keywords
- child, adolescent, psychiatry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 9 Feb 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.
Paediatric behavioural, developmental, and mental health issues are more common than childhood cancers, cardiac problems, and renal problems combined.
Behavioural problems have often been conceptualized along two broad spectrums: internalizing problems which are expressed in intrapersonal manifestation, such as anxiety, depression, and withdrawal; and externalizing problems which are demonstrated in interpersonal manifestation, such as hyperactivity and aggression The lack of attention to the mental health of children and adolescents may lead to mental disorders with lifelong consequences, undermines compliance with health regimens, and reduces the capacity of societies to be safe and productive. As, children and adolescent mental health problems often have serious long term debilitating effects . Early identification and treatment of these problems are in the best interest of children, adolescents, their families, and society as a whole . All three essential ways in which epidemiology can contribute to our understanding of children and adolescent mental health: community burden, measurement, and triage were of utmost importance. planning and conducting the survey.
In this study the researchers will present the first large-scale survey of child and adolescent psychiatric disorders at Assiut government For adequate planning of services, including evidence-based mental health prevention and intervention, a population-representative survey of children and adolescent estimating mental disorders was urgently needed
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This is study will take part in the first screening phase in the Assiut government school community study. The other part will be in the child and adolescent psychiatry clinic at Neurology and Psychiatry department at Assiut university hospital.
Key inclusion criteria (3 listed)
- age of children (6-18 years)
- both males and females.
- have education in school at Assiut government.
Key exclusion criteria (1 listed)
- 1- unwilling parent to recruited in the study.
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 |
|---|---|---|
| 1. The Child Behavior Checklist (CBCL), parent formIt consists of 113 items; the parents complete it to detect emotional and behavioural problems in children and adolescents aged 6 to 18 years. It is scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). The time duration for item responses is the past six months. | Behavioural | – |
Primary outcome
measure the prevalence of DSM 5 psychiatric disorders in the community sample of school children in Assiut government.
Time frame: through study completion, an average of 1 year
measure of risk factor of DSM 5 psychiatric disorders in the community sample of school children in Assiut government.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Behavior Disorders and Child Mental Disorder, run by Assiut University at 1 site in Egypt.
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 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 gellan R Ahmed (01093663928, gillankaram@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure the prevalence of DSM 5 psychiatric disorders in the community sample of school children in Assiut government. (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2021.