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NCT05370443 | Enrolling by invitation | Mental Disorder in Adolescence


Effectiveness of an Online Life Skills-based Intervention on Mental Health
Sponsor:

Universiti Putra Malaysia

Information provided by (Responsible Party):

Yousra Muhammad M. Sharif

Brief Summary:

It is a parallel cluster randomised controlled trial designed to assess the effectiveness of an online life skills education in reducing depression, anxiety, and stress and improving self-efficacy and coping skills among Arabic secondary school students at Arabic schools in Klang Valley in Malaysia.

Condition or disease

Mental Disorder in Adolescence

Intervention/treatment

Life Skills education program

Phase

Not Applicable

Detailed Description:

Children and adolescents' mental health is a global public health issue. Worldwide, it is estimated between 10% and 20% of children and adolescents suffer from mental health problems. Depression and anxiety are the most frequently encountered mental disorders which significantly impact children and adolescents. These disorders have been shown to increase the risk of adverse outcomes such as impairment, loss of productivity and community involvement, decreased educational performance, increased likelihood of engaging in risky behaviours, disability, and increased self-harm and suicide rates. Migrant children and adolescents are at increased risk of these mental disorders, mainly Arabic immigrants. Arab adolescents face additional challenges such as high illiteracy rates, inadequate health services and poor access to health facilities, especially mental health facilities. There is also a clear trend of the increasing burden of mental disorders in the Arabic countries from 1990 to 2015 compared to the global average. This study examines the effectiveness of an online life skills-based intervention in reducing depression, anxiety and stress and improving self-efficacy and coping skills among Arabic secondary school students in Klang Valley in Malaysia. The life skills intervention modules and activities will be developed based on the WHO and UNICEF guidelines for implementing life skills. This program will also undergo a process of consultations with a group of experts. The intervention group will receive education videos and discussion sessions that will target self-awareness, Empathy, Interpersonal relationship skills, Communication skills, Critical and creative thinking, problem-solving, decision-making, and coping with stress and emotion. The sessions will be carried out per week for 1 hour for eight consecutive weeks via the zoom platform. Before conducting the intervention, all the participants will receive a short reminder SMS for enrolling in the online session. The control group will receive the education program after finishing the study.}}

Study Type : Interventional
Estimated Enrollment : 200 participants
Masking : Double
Masking Description : No one in the control groups will know what the experimental groups will be offered. The the statistician who will perform the primary analyses will be blinded to group allocation.
Primary Purpose : Treatment
Official Title : Effectiveness of an Online Life Skills-based Intervention on Depression, Anxiety and Stress Among Arabic Adolescents in Klang Valley, Malaysia: Protocol for a Cluster-randomized Controlled Trial
Actual Study Start Date : December 1, 2022
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : July 1, 2023
Arm Intervention/treatment

Experimental: Life Skills intervention group

The participants in the intervention group will receive eight sessions of the online life skills educational program via the zoom platform for eight weeks. Each session will last for 1-hour. All the participants will receive a short reminder SMS for enrolling in the online session. The assessment for all students will be done at baseline, immediate and 3-months post-intervention.

No Intervention: control group

Participants in the control group will receive no intervention during the study period. However, they will receive the same educational activities after finishing study. They will answer the same questionnaires at baseline, immediately following the intervention, and three months later.

Ages Eligible for Study: 14 Years to 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • The inclusion criteria for schools are
    • Arabic schools that agree to participate.
    • The Arabic schools are located in Klang Valley.
    • The inclusion criteria for students
      • Arabic Students aged from 14 to 18 years old.
      • students who give the assent and consent from their parents.
      • Students who have scored mild to extremely severe score in depression, anxiety and stress based on baseline assessment (screening stage).
      Exclusion Criteria
      • The exclusion criteria for schools are
        • non-Arabic schools that have Arabic students.
        • Schools that refuse to participate in the study.
        • The exclusion criteria for students
          • students who refuse to participate.
          • Students who have hearing limitations because they cannot interact during the online session.
          • Students who have been diagnosed or treated for mental health problems before based on their school file because it may interfere with the effect of the program.

Effectiveness of an Online Life Skills-based Intervention on Mental Health

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Effectiveness of an Online Life Skills-based Intervention on Mental Health

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Locations


Not yet recruiting

Malaysia, Selangor

Arabic schools in Klang Valley, Malaysia

Serdang, Selangor, Malaysia,

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