Child Behavior DisordersNCT04762394
Epidemiology of Psychiatric Disorders in Children and Adolescent at Egypt
An observational study of Child Behavior Disorders and Child Mental Disorder, run by Assiut University at 1 site in Egypt.
Trial summary
Pediatric, developmental and mental health problems are more common than renal, cardiac and renal problems. Compartmental problems were often conceptualised across two broad spectrums: internalising intrapersonal problems like anxiety, depression and withdrawal and externalising problems such as Interpersonal problems… Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior Disorders, Child Mental Disorder, Adolescent Behaviour Disorder
- What is being tested?
- The Child Behavior Checklist (CBCL),
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2021to 20 Feb 2023
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This is study will take part in community study( nursery and schools).
Who may be able to join
- age of children (2-18 years)
- both males and females.
- living in Egypt.
Who cannot join
- unwilling parent to recruited in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
gellan Ahmed
Asyut, 71111
gellan Ahmed, +201093663928, gillankaram@aun.edu.eg
About this study
Official title: Epidemiology of Psychiatric Disorders Among Preschool and School Children and Adolescent in Egypt
Pediatric, developmental and mental health problems are more common than renal, cardiac and renal problems.
Compartmental problems were often conceptualised across two broad spectrums: internalising intrapersonal problems like anxiety, depression and withdrawal and externalising problems such as Interpersonal problems such as hyperactivity and aggression.
Read more
Mental disorders with long-term consequences can result in children and adolescents, undermining health compliance and reducing societies' ability to be safe and productive. As, children and adolescent have long-term deteriorating effects of mental health problems are often serious.
Early detection and identification of problems are in the best interest of children, adolescents, their families, and the community as a whole. All three are important.
how epidemiology can help our understanding of children and adolescent mental health: the burden of the community, measurement and tracking highly significant.
This study will display the first large-scale study of psychiatric disorders in children and adolescents in the Egypt . to provide services, including prevention and intervention based on evidence of mental health, a population-representative child survey and adolescent mental estimates disorders were needed urgently
- Being tested
- The Child Behavior Checklist (CBCL),
- 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.
The Child Behavior Checklist (CBCL),Behavioural
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.
by using The Child Behavior Checklist (CBCL):It consists of 113 items, the parents complete it to detect emotional and behavioural problems in children and adolescents .It includes open-ended items covering physical problems, concerns, and strengths. The CBCL/6-18 yields scores on internalizing, externalizing, and total problems as well as scores on DSM-5 related scales.It is providing a total behaviour problem score and two second order factor scores for internalizing problems (anxious/depressed, somatic complaints, withdrawn/depressed) and externalizing behaviour (rule breaking behaviour and aggressive problems).
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.
Patients were subjected to a full psychiatric and medical assessment at the beginning of the study. A semistructured form was prepared by researchers to detect sociodemographic and clinical variables of the patients, and the medical history of the patients were reviewed. Information gathered included age, sex, birth order, pregnancy problems, delivery type, birth complications, delay of speech development, delay of motor development, family history of consanguinity
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 posted21 Feb 2021
- Study start20 Feb 2021 (estimated)
- Primary completion20 Feb 2022 (estimated)
- Study completion20 Feb 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)
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
- NCT04762394
- Sponsor's protocol ID
- Assiut university, Egypt
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Psychiatric Disorders Among Preschool and School Children and Adolescent in Egypt
- ClinicalTrials.gov ID
- NCT04762394
- Acronym / sponsor ID
- Assiut university, Egypt
- Keywords
- child, adolescent, psychiatry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Feb 2021 (estimated)
- Primary completion
- 20 Feb 2022 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 21 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.
Pediatric, developmental and mental health problems are more common than renal, cardiac and renal problems.
Compartmental problems were often conceptualised across two broad spectrums: internalising intrapersonal problems like anxiety, depression and withdrawal and externalising problems such as Interpersonal problems such as hyperactivity and aggression.
Mental disorders with long-term consequences can result in children and adolescents, undermining health compliance and reducing societies' ability to be safe and productive. As, children and adolescent have long-term deteriorating effects of mental health problems are often serious.
Early detection and identification of problems are in the best interest of children, adolescents, their families, and the community as a whole. All three are important.
how epidemiology can help our understanding of children and adolescent mental health: the burden of the community, measurement and tracking highly significant.
This study will display the first large-scale study of psychiatric disorders in children and adolescents in the Egypt . to provide services, including prevention and intervention based on evidence of mental health, a population-representative child survey and adolescent mental estimates disorders were needed urgently
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This is study will take part in community study( nursery and schools).
Key inclusion criteria (3 listed)
- age of children (2-18 years)
- both males and females.
- living in Egypt.
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| The Child Behavior Checklist (CBCL),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. | 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
by using The Child Behavior Checklist (CBCL):It consists of 113 items, the parents complete it to detect emotional and behavioural problems in children and adolescents .It includes open-ended items covering physical problems, concerns, and strengths. The CBCL/6-18 yields scores on internalizing, externalizing, and total problems as well as scores on DSM-5 related scales.It is providing a total behaviour problem score and two second order factor scores for internalizing problems (anxious/depressed, somatic complaints, withdrawn/depressed) and externalizing behaviour (rule breaking behaviour and aggressive problems).
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
Patients were subjected to a full psychiatric and medical assessment at the beginning of the study. A semistructured form was prepared by researchers to detect sociodemographic and clinical variables of the patients, and the medical history of the patients were reviewed. Information gathered included age, sex, birth order, pregnancy problems, delivery type, birth complications, delay of speech development, delay of motor development, family history of consanguinity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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 21 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 Ahmed, PhD (+201093663928, 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 21 Feb 2021.