Clinical trial NCT05370443: Effectiveness of an Online Life Skills-based Intervention on Mental Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder in Adolescence
Keywords: Depression, Anxiety Stress, Life Skills, Arabic adolescents
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 339
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is quantitative in nature and experimental in design. Specifically, this is a parallel cluster-randomized controlled trial. The schools will be the unit of randomisation (clusters). Arabic schools will be randomised in a 1:1 ratio to be either in the intervention (Life Skills educational program) or control group (waiting list). The participants will be asked to fill out the online form of the DASS-21 questionnaires (the screening stage). Then participants with a score of mild to extra-sever on at least one (depression, stress or anxiety) will be included in the life skills intervention study and will fill the second two parts of the questionnaires (GES and Brief Cope Scale).
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in the depression, anxiety and stress mean scores
timeFrame: Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
Secondary outcomes:
measure: Change in the Self-efficacy mean score
timeFrame: Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
measure: Change in coping skills mean score
timeFrame: Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Arabic schools in Klang Valley, Malaysia
state: Selangor
Study officials:
affiliation: UPM
name: Ahmad Z Fattah Azman
role: STUDY_CHAIR
References:
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citation: Singla DR, Waqas A, Hamdani SU, Suleman N, Zafar SW, Zill-E-Huma, Saeed K, Servili C, Rahman A. Implementation and effectiveness of adolescent life skills programs in low- and middle-income countries: A critical review and meta-analysis. Behav Res Ther. 2020 Jul;130:103402. doi: 10.1016/j.brat.2019.04.010. Epub 2019 Apr 26.
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