Psychiatric and ThalassemiaNCT06601556
Psychiatric Problems in Thalassemic Children
An observational study of Psychiatric and Thalassemia and Psychiatry and Thalassemia, run by Assiut University.
Trial summary
Aims of the study : 1. Assessment the prevalence of psychiatric problems in thalassemic children . 2. Assessment the prevalence of cognitive problems in thalassemic children . 3. Determine factors associated with psychiatric and cognitive problems in thalassemic children . Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Psychiatric and Thalassemia, Psychiatry and Thalassemia
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2024to 20 Mar 2026
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Thalassemic patients between 6 and 12 years old
Who may be able to join
- 1. Age between 6 to \< 12 years.
Who cannot join
- Patients who had bone marrow transplant and were cured of thalassemia .
- Neurological illness preventing them from expressing themselves and not able to communicate well
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Psychiatric Problems Among Thalassemic Children in Assuit University Children Hospital
Aims of the study :
- Assessment the prevalence of psychiatric problems in thalassemic children .
- Assessment the prevalence of cognitive problems in thalassemic children .
- Determine factors associated with psychiatric and cognitive problems in thalassemic children .
Sociodemographic information, other associated factors , CBCL (Child Behaviour Check List) and Children's Sleep Habits Questionnaire will be collected by thalassemic child's caregiver interview at Assiut university ,Children hospital , pediatric hematology unit .
Raven´s Colored Progressive Matrices will be solved by thalassemic patient at Assiut university , Children hospital , pediatric hematology unit .
Read the detailed description
Beta-thalassemia is a chronic and genetically determined hematological disorder characterized by severe hemolytic anemia as a result of deficient synthesis of β chains of hemoglobin.
β-Thalassemia major is considered the commonest hemoglobinopathy in the Mediterranean area particularly Egypt with an estimated carrier rate of 9-10.2 % . From about registered β-thalassemia cases ; 95% of them are β-thalassemia major, and 5% are thalassemia intermediate.
It demands frequent blood transfusions to maintain life, while haemosiderosis and other complications of the disease require a continuous and distressing treatment regimen that includes parenteral iron chelation treatment and regular medical supervision.
The drawbacks of the disease in many aspects of life become strongly evident during the school age when children ask for independence . It has been related with psychosocial aspect and a significant negative effect on areas of school functioning because of the likelihood of physical deformity, growth retardation and delayed puberty besides the difficulty of management (such as regular transfusion and time-consuming iron chelation treatment) Social stigma associated with having thalassaemia have significant psychosocial and emotional impact on patients and their families(3) , so The affected children become more liable to emotional, social, psychological and behavioural problems .
No available studies about psychiatric problems among thalassemic children in Egypt . Also study that were conducted in the age \&lt; 12 years are few .
- Medical subject headings
- Thalassemia
What is being measured
The primary outcome is the main question the study is designed to answer.
• Assessment the prevalence of psychiatric problems in thalassemic children
By using CBCL (Child Behaviour Check List) is a questionnaire based standardized tool used for assessing behavioural problems(6) . CBCL for school aged children (6-18 years) in local language is filled by the primary caregivers/parents after obtaining written consent . It contains 113 questions categorized into eight domains which are anxious/depressed, withdrawn, somatic complaints, social problems, thought problems, attention problems, rule breaking behaviour and aggressive behaviour.(7)
Measured: One year
Secondary outcomes (1)
• Determine factors associated with psychiatric and cognitive problems in thalassemic children . • Assessment the prevalence of cognitive problems in thalassemic children
By using Raven´s Colored Progressive Matrices (CPM)-Sets A, AB, B standardized for the population between 6 and 11 years old, comprises 36 items, in which the subject is required to indicate the correct target among six alternatives. Grouped into three sets (A, AB, B) of 12 items in each one, the CPM solving requires different abilities, namely: A Series, requiring visuo-perceptual ability; AB Series, symmetric ability; and B Series, conceptual and analogic thought abilities
Associated factor by sociodemographic data Name, age, gender, residence (urban or rural and live with family or extended family) and education (student or not , and if not the last degree) and socioeconomic level by by Fahmy and El Sherbini Socio- economic status (SES) scale.the scale consist of 7 domains with total score 84, each domain contain many items that collectively it can measure the socioeconomic status of the family
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Oct 2024 (estimated)
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric and ThalassemiaStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Amary, Assiut University
- Investigators
- Gellan Gellan Karamallah, Lecturer, Study director, Assiut UniversityKhaled Khaled Elsayh, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601556
- Sponsor's protocol ID
- Psychiatric in thalassemia
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Psychiatric Problems Among Thalassemic Children in Assuit University Children Hospital
- ClinicalTrials.gov ID
- NCT06601556
- Acronym / sponsor ID
- Psychiatric in thalassemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Aims of the study :
- Assessment the prevalence of psychiatric problems in thalassemic children .
- Assessment the prevalence of cognitive problems in thalassemic children .
- Determine factors associated with psychiatric and cognitive problems in thalassemic children .
Sociodemographic information, other associated factors , CBCL (Child Behaviour Check List) and Children's Sleep Habits Questionnaire will be collected by thalassemic child's caregiver interview at Assiut university ,Children hospital , pediatric hematology unit .
Raven´s Colored Progressive Matrices will be solved by thalassemic patient at Assiut university , Children hospital , pediatric hematology unit .
Detailed description
Beta-thalassemia is a chronic and genetically determined hematological disorder characterized by severe hemolytic anemia as a result of deficient synthesis of β chains of hemoglobin.
β-Thalassemia major is considered the commonest hemoglobinopathy in the Mediterranean area particularly Egypt with an estimated carrier rate of 9-10.2 % . From about registered β-thalassemia cases ; 95% of them are β-thalassemia major, and 5% are thalassemia intermediate.
It demands frequent blood transfusions to maintain life, while haemosiderosis and other complications of the disease require a continuous and distressing treatment regimen that includes parenteral iron chelation treatment and regular medical supervision.
The drawbacks of the disease in many aspects of life become strongly evident during the school age when children ask for independence . It has been related with psychosocial aspect and a significant negative effect on areas of school functioning because of the likelihood of physical deformity, growth retardation and delayed puberty besides the difficulty of management (such as regular transfusion and time-consuming iron chelation treatment) Social stigma associated with having thalassaemia have significant psychosocial and emotional impact on patients and their families(3) , so The affected children become more liable to emotional, social, psychological and behavioural problems .
No available studies about psychiatric problems among thalassemic children in Egypt . Also study that were conducted in the age \&lt; 12 years are few .
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Thalassemic patients between 6 and 12 years old
Key inclusion criteria (1 listed)
- 1. Age between 6 to \< 12 years.
Key exclusion criteria (2 listed)
- Patients who had bone marrow transplant and were cured of thalassemia .
- Neurological illness preventing them from expressing themselves and not able to communicate well
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
• Assessment the prevalence of psychiatric problems in thalassemic children
Time frame: One year
By using CBCL (Child Behaviour Check List) is a questionnaire based standardized tool used for assessing behavioural problems(6) . CBCL for school aged children (6-18 years) in local language is filled by the primary caregivers/parents after obtaining written consent . It contains 113 questions categorized into eight domains which are anxious/depressed, withdrawn, somatic complaints, social problems, thought problems, attention problems, rule breaking behaviour and aggressive behaviour.(7)
1 secondary outcome
• Determine factors associated with psychiatric and cognitive problems in thalassemic children . • Assessment the prevalence of cognitive problems in thalassemic children
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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.
Gellan Gellan Karamallah, Lecturer study director
Assiut University
Khaled Khaled Elsayh, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric and Thalassemia and Psychiatry and Thalassemia, 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 2 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 19 Sep 2024. 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 Marwa Amary Marwa Amary, Resident doctor (+201110673238, marwa.amary34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Assessment the prevalence of psychiatric problems in thalassemic children (time frame: One year). 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 19 Sep 2024; AzTrials last refreshed its copy on 30 Oct 2026.