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

Primary Purpose

Mental Disorder in Adolescence

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Life Skills education program
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorder in Adolescence focused on measuring Depression, Anxiety Stress, Life Skills, Arabic adolescents

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arabic schools in Klang Valley, Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Life Skills intervention group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
May 6, 2022
Last Updated
January 11, 2023
Sponsor
Universiti Putra Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05370443
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder in Adolescence
Keywords
Depression, Anxiety Stress, Life Skills, Arabic adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantOutcomes Assessor
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.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Life Skills intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Life Skills education program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the depression, anxiety and stress mean scores
Description
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.
Time Frame
Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
Secondary Outcome Measure Information:
Title
Change in the Self-efficacy mean score
Description
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.
Time Frame
Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
Title
Change in coping skills mean score
Description
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
Time Frame
Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Z Fattah Azman
Organizational Affiliation
UPM
Official's Role
Study Chair
Facility Information:
Facility Name
Arabic schools in Klang Valley, Malaysia
City
Serdang
State/Province
Selangor
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31877163
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):e0226333. doi: 10.1371/journal.pone.0226333. eCollection 2019.
Results Reference
result
PubMed Identifier
32034632
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 Adolesc. 2020 Jun;49(6):1127-1145. doi: 10.1007/s10964-020-01201-5. Epub 2020 Feb 7.
Results Reference
result
PubMed Identifier
28050189
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.
Results Reference
result
PubMed Identifier
31146889
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.
Results Reference
result
PubMed Identifier
28095477
Citation
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.
Results Reference
result

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

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