Development of THALEA Kit and Its Impact on Knowledge, Attitude, and Intention for Premarital Thalassemia Screening

NCT ID: NCT06800495

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-12-31

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)

Conditions

Thalassemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention arm

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.

Group Type: EXPERIMENTAL

THALEA (Thalassemia Education and Awareness) Kit

Intervention Type: BEHAVIORAL

By using the opinions obtained by the experts, THALEA's content will then be designed using the Theory of Planned Behaviour (TPB) by Ajzen and Fishbein.

Development of THALEA:

• Language: Malay and English.

• Contents of the THALEA kit: i. PowerPoint or Canva presentations with discussion prompts (softcopy form) ii. Links/joining codes to free educational game platforms such as Kahoot or Quizziz iii. Videos - convey messages on thalassemia awareness and screening importance.

iv. Illustrated guides/brochures - to provide step-by-step tutorials on how to get thalassemia screening in both the public and private healthcare.

• Developer would be the main researcher with aid from: i. Illustrator ii. Video graphic designer iii. Influencers

• Delivery of THALEA to students by: i. Medical personnel

Comparison arm

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.

Group Type: ACTIVE_COMPARATOR

Basic thalassemia and family health education

Intervention Type: BEHAVIORAL

They are 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.

Interventions

THALEA (Thalassemia Education and Awareness) Kit

By using the opinions obtained by the experts, THALEA's content will then be designed using the Theory of Planned Behaviour (TPB) by Ajzen and Fishbein.

Development of THALEA:

• Language: Malay and English.

• Contents of the THALEA kit: i. PowerPoint or Canva presentations with discussion prompts (softcopy form) ii. Links/joining codes to free educational game platforms such as Kahoot or Quizziz iii. Videos - convey messages on thalassemia awareness and screening importance.

iv. Illustrated guides/brochures - to provide step-by-step tutorials on how to get thalassemia screening in both the public and private healthcare.

• Developer would be the main researcher with aid from: i. Illustrator ii. Video graphic designer iii. Influencers

• Delivery of THALEA to students by: i. Medical personnel

Intervention Type: BEHAVIORAL

Basic thalassemia and family health education

They are 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

THALEA

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Teknologi Mara

OTHER

Sponsor Role: lead

Responsible Party

Maisarah binti Noor Anwar

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Teknologi MARA

Sungai Buloh, Selangor, Malaysia

Countries

Malaysia

Other Identifiers

Other funds

Identifier Type: OTHER

Identifier Source: secondary_id

THALEA

Identifier Type: -

Identifier Source: org_study_id