NCT05370443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
339

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 6, 2022

Last Update Submit

May 8, 2024

Conditions

Keywords

Depression, Anxiety Stress, Life Skills, Arabic adolescents

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in the Self-efficacy mean score

    Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention

  • Change in coping skills mean score

    Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention

Study Arms (2)

Life Skills intervention group

EXPERIMENTAL

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.

Behavioral: Life Skills education program

control group

NO INTERVENTION

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.

Interventions

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.

Life Skills intervention group

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Arabic schools that agree to participate.
  • The Arabic schools are located in Klang Valley.
  • 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).

You may not qualify if:

  • non-Arabic schools that have Arabic students.
  • Schools that refuse to participate in the study.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arabic schools in Klang Valley, Malaysia

Serdang, Selangor, Malaysia

Location

Related Publications (6)

  • 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):e0226333. doi: 10.1371/journal.pone.0226333. eCollection 2019.

  • 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 Adolesc. 2020 Jun;49(6):1127-1145. doi: 10.1007/s10964-020-01201-5. Epub 2020 Feb 7.

  • 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.

  • 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.

  • 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, Husseini A, Abu-Raddad LJ, Khoja T, Al Rayess ZA, AlBuhairan FS, Hsairi M, Alomari MA, Ali R, Roshandel G, Terkawi AS, Hamidi S, Refaat AH, Westerman R, Kiadaliri AA, Akanda AS, Ali SD, Bacha U, Badawi A, Bazargan-Hejazi S, Faghmous IA, Fereshtehnejad SM, Fischer F, Jonas JB, Kuate Defo B, Mehari A, Omer SB, Pourmalek F, Uthman OA, Mokdad AA, Maalouf FT, Abd-Allah F, Akseer N, Arya D, Borschmann R, Brazinova A, Brugha TS, Catala-Lopez F, Degenhardt L, Ferrari A, Haro JM, Horino M, Hornberger JC, Huang H, Kieling C, Kim D, Kim Y, Knudsen AK, Mitchell PB, Patton G, Sagar R, Satpathy M, Savuon K, Seedat S, Shiue I, Skogen JC, Stein DJ, Tabb KM, Whiteford HA, Yip P, Yonemoto N, Murray CJ, Mokdad AH. The Burden of Mental Disorders in the Eastern Mediterranean Region, 1990-2013. PLoS One. 2017 Jan 17;12(1):e0169575. doi: 10.1371/journal.pone.0169575. eCollection 2017.

  • Sherif Y, Fattah Azman AZ, Said SM, Siddiqah Alimuddin A, Awang H, Mohammadzadeh M. Effect of online intervention based on life skills for mental health, self-efficacy and coping skills among Arab adolescents in the Klang Valley, Malaysia: A cluster randomised controlled trial protocol. PLoS One. 2024 Feb 23;19(2):e0298627. doi: 10.1371/journal.pone.0298627. eCollection 2024.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Ahmad Z Fattah Azman

    UPM

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 11, 2022

Study Start

November 1, 2022

Primary Completion

April 1, 2023

Study Completion

June 1, 2023

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations