Mental Disorder in AdolescenceNCT05370443
Effectiveness of an Online Life Skills-based Intervention on Mental Health
A study testing Life Skills education program in people with Mental Disorder in Adolescence, run by Universiti Putra Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Mental Disorder in Adolescence
- What is being tested?
- Life Skills education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Nov 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Mental Disorder in Adolescence
- Being tested
- Life Skills education program
- Keywords
- Depression, Anxiety Stress, Life Skills, Arabic adolescents
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Skills education programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
Secondary outcomes (2)
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.
Measured: Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
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
Measured: Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Nov 2022
- Primary completion1 Apr 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mental Disorder in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YOSRA MOHAMED M SHERIF, Universiti Putra Malaysia
- Investigators
- Ahmad Z Fattah Azman, Study chair, UPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370443
- Sponsor's protocol ID
- JKEUPM-2021-912
- Status last verified
- May 2024
- First submitted
- 6 May 2022
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31877163van 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.
PubMed 32034632Jamali 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.
PubMed 28050189Singla 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.
PubMed 31146889Charara 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.
PubMed 28095477Sherif 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.
PubMed 38394185
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05370443
- Acronym / sponsor ID
- JKEUPM-2021-912
- Conditions
- Mental Disorder in Adolescence
- Keywords
- Depression, Anxiety Stress, Life Skills, Arabic adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Life Skills intervention group | Experimental | Behavioral: Life Skills education programThe 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. |
| 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- The inclusion criteria for schools are:
- 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).
Key exclusion criteria (7 listed)
- The exclusion criteria for schools are:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life Skills education programThe 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. | Behavioural | Life Skills intervention group |
Primary outcome
Change in the depression, anxiety and stress mean scores
Time frame: Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
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.
2 secondary outcomes
Change in the Self-efficacy mean score
Time frame: Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
Change in coping skills mean score
Time frame: Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Results publication: PubMed 31877163Mohammadzadeh 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 publication: PubMed 32034632van 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 publication: PubMed 28050189Jamali 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 publication: PubMed 31146889Singla 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 publication: PubMed 28095477Charara 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.
- Derived from this study: PubMed 38394185Sherif 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Z Fattah Azman study chair
UPM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Skills education program in people with Mental Disorder in Adolescence, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the depression, anxiety and stress mean scores (time frame: Measurement will be pre-intervention(baseline), immediately post-intervention and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370443, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.