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

Mental Disorder in Adolescence Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05370443
• Other study ID #: JKEUPM-2021-912
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2022
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: July 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorder in Adolescence
• Mental Disorders

Intervention

Behavioral:
• Life Skills education program
The World Health Organization (WHO), describes life skills as "abilities for adaptive and positive behaviour that enables individuals to deal effectively with the demands and challenges of everyday life". Life Skills Education includes activities that support critical and creative thinking, coping with emotions and stress, self-awareness and empathy, decision-making and problem-solving, communication skills, and interpersonal relations.

Locations

Country	Name	City	State
Malaysia	Arabic schools in Klang Valley, Malaysia	Serdang	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (5)

Charara R, Forouzanfar M, Naghavi M, Moradi-Lakeh M, Afshin A, Vos T, Daoud F, Wang H, El Bcheraoui C, Khalil I, Hamadeh RR, Khosravi A, Rahimi-Movaghar V, Khader Y, Al-Hamad N, Makhlouf Obermeyer C, Rafay A, Asghar R, Rana SM, Shaheen A, Abu-Rmeileh NM, — View Citation

Jamali S, Sabokdast S, Sharif Nia H, Goudarzian AH, Beik S, Allen KA. The Effect of Life Skills Training on Mental Health of Iranian Middle School Students: A Preliminary Study. Iran J Psychiatry. 2016 Oct;11(4):269-272. — View Citation

Mohammadzadeh M, Awang H, Ismail S, Kadir Shahar H. Improving emotional health and self-esteem of Malaysian adolescents living in orphanages through Life Skills Education program: A multi-centre randomized control trial. PLoS One. 2019 Dec 26;14(12):e0226 — View 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. 2 — View Citation

van Loon AWG, Creemers HE, Beumer WY, Okorn A, Vogelaar S, Saab N, Miers AC, Westenberg PM, Asscher JJ. Can Schools Reduce Adolescent Psychological Stress? A Multilevel Meta-Analysis of the Effectiveness of School-Based Intervention Programs. J Youth Adol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the depression, anxiety and stress mean scores	Depression, Anxiety Stress Scales-21 ( DASS-21). The DASS-21 is a set of three self-report scales designed to measure depression, anxiety, and stress. Each of the three sets of the DASS21 scales include seven items with a 4-point Likert scale. The minimum and maximum DASS21 scores are 0 and 21 for each subscale. Higher scores indicate higher levels of problems.	Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
Secondary	Change in the Self-efficacy mean score	The General Self-Efficacy Scale (GES). The GES is a 10-item psychometric scale rated on a 4-point Likert scale, ranging from 10-40, and a higher score indicates more self-efficacy. It is used to assess the strength of an individual's belief in his or her own ability to respond to new situations, obstacles, or life stresses.	Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
Secondary	Change in coping skills mean score	Brief COPE Inventory is a self-report questionnaire consisting of 28 statements with a 4-point Likert scale to evaluate 14 different ways of coping with stressful situations. The minimum and maximum scores on the original Brief COPE questionnaire are 2 and 8, respectively, for each subscale. Higher scores reflect a higher tendency to implement the corresponding coping strategies	Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention