Clinical trial NCT06800495: Development of THALEA Kit and Its Impact on Knowledge, Attitude, and Intention for Premarital Thalassemia Screening
Official title: Development of THALEA (Thalassemia Education and Awareness) Kit and a Cluster Randomised Control Trial to Evaluate Its Effectiveness on Knowledge, Attitude, and Intention Regarding Premarital Thalassemia Screening Among Private Secondary School Students of Klang Valley, Malaysia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Thalassemia
Keywords: Thalassemia
Educational intervention
secondary school students
THALEA
Thalassemia awareness
Premarital Thalassemia screening
Thalassemia education
thalassemia educational intervention
high school students
Malaysia
knowledge, attitude and intention
Lead sponsor: Universiti Teknologi Mara
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 148
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: THALEA (Thalassemia education and awareness) Kit is an educational intervention for secondary school students that is developed according to the theory of planned behaviour. It is to be delivered to high school students by a medical practitioner
Primary purpose: PREVENTION

Brief summary: Thalassemia, a common genetic disease, is often overlooked compared to infectious diseases like HIV, despite its significant effects for families planning to have children. Thalassemia carriers are frequently asymptomatic, but when two carriers marry, there is a 25% chance of having a child with a severe form of the disease. Although screening programs exist, the number of symptomatic thalassemia major continues to increase, and current treatments are primarily symptomatic, merely prolonging survival rather than curing it.

In Malaysia, while HIV testing before marriage is mandatory, thalassemia screening is not. Presently, thalassemia screening and awareness programs are offered to fourth-form students in government schools only. Hence, there is a need to complement existing national screening efforts by creating a standardized thalassemia awareness program that can be effectively implemented across diverse educational institutions.

Our main objective is to develop and validate the THALEA (Thalassemia education and awareness) kit and evaluate its effectiveness among secondary school students in Klang Valley, Malaysia. We hope that with this intervention, high school students are be able to increase their awareness and knowledge, instil a positive attitude and have that intention to do a pre-marital thalassemia screening at any healthcare facility in our country. This can facilitate early detection and timely counselling to reduce the risk of having children with severe thalassemia.

Delivery of the intervention:

i. Schools will be approached by letter, followed by a phone call and a visit. ii. Consent forms will be given for parents to sign. iii. All fourth form students at the school will be invited to participate in the study, excluding those who meet the exclusion criteria.

iv. THALEA will be delivered by a face-to-face method between the main researcher and the students.

v. Frequency of delivery - one time only vi. Duration of intervention - 2-3 hours. vii. The intervention group will receive THALEA along with a basic family health education. THALEA's session comprises a face-to-face verbal presentation facilitated by the primary researcher, featuring an engaging interactive seminar and on-screen games. Following this, participants will be presented with 3-5-minute videos and pictorial materials, fostering two-way discussions. Subsequently, a softcopy of the THALEA kit will be distributed to the teacher in charge via email or WhatsApp after the seminar for further dissemination. The students will receive THALEA's brochures.

viii. The comparison group will only receive a basic family health education in which it is the usual family health education given by the MOH, usually delivered by a medical officer, to fourth form students at government schools prior to the thalassemia screening programme. It will consist of a delivery of a PowerPoint presentation and videos, that will be obtained from government public health clinics in Klang Valley.

We will use a self-administered questionnaire designed and validated to assess knowledge, attitude, and intention regarding premarital thalassemia screening among youths at three different time points which are during pre-assessment (t0), immediate post-assessment (t1), and 2 weeks post assessment (t2)


Eligibility criteria: Inclusion Criteria:

* Malaysians.
* Fourth form students.
* Able to read and write in either Malay or the English language.

Exclusion Criteria:

* Those who have previously undergone thalassemia screening
* Identified as thalassemia carriers
* Without parental consent or assent
* Has first-degree relatives diagnosed with thalassemia

Primary outcomes:
measure: Knowledge and attitude score
timeFrame: i. All students will be given 5 minutes to fill in their demographic information ii. Then 10 to 15 minutes will be given to answer the questionnaire at three different time points which are during pre-assessment (t0), immediate post-assessment (t1), and
Secondary outcomes:
measure: Intention regarding premarital thalassemia screening
timeFrame: i. All students will be given 5 minutes to fill in their demographic information ii. Then 10 to 15 minutes will be given to answer the questionnaire at three different time points which are during pre-assessment (t0), immediate post-assessment (t1), and
Other outcomes:
Locations:
city: Sungai Buloh
country: Malaysia
facility: University Teknologi MARA
state: Selangor
Study officials:
References: