Psychiatric Problems in Thalassemic Children

September 15, 2024 updated by: Marwa Amary, Assiut University

Evaluation of Psychiatric Problems Among Thalassemic Children in Assuit University Children Hospital

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 .

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 .

Study Overview

Status

Not yet recruiting

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 < 12 years are few .

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Thalassemic patients between 6 and 12 years old

Description

Inclusion Criteria:

  • 1. Age between 6 to < 12 years.

Exclusion Criteria:

  1. Patients who had bone marrow transplant and were cured of thalassemia .
  2. Neurological illness preventing them from expressing themselves and not able to communicate well

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• 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)
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Determine factors associated with psychiatric and cognitive problems in thalassemic children . • Assessment the prevalence of cognitive problems in thalassemic children
Time Frame: One year

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

One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Gellan Gellan Karamallah, Lecturer, Assiut University
  • Study Director: Khaled Khaled Elsayh, Professor, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 20, 2024

Primary Completion (Estimated)

January 20, 2026

Study Completion (Estimated)

March 20, 2026

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 15, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 15, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Psychiatric in thalassemia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe