Mental Disorder in AdolescenceNCT05865834
Improvement of Mental Health in Adolescents Using E-health Interventions
A study testing A smartphone application and Pictorial educational leaflets in people with Mental Disorder in Adolescence and Depression in Adolescence, run by Aga Khan University at 1 site in Pakistan.
Trial summary
the goal of this cluster randomized controlled trial is to assess the effectiveness of smartphone application in reducing the symptoms of Anxiety and depression among adolescents. The main objectives of this trial are: 1. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder in Adolescence, Depression in Adolescence, Anxiety Disorders
- What is being tested?
- A smartphone application and Pictorial educational leaflets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2023to 15 Nov 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Registered secondary schools with the Board of Secondary Education Karachi who will provide consent to participate in the study
- 12-18-year-olds adolescents enrolled in public and private school of Karachi Pakistani
- The intervention and control arm must understand English or Urdu in order to use the mobile-based application.
- Intervention group must have access to a smartphone or portable smart device (Electronic Tablets, iPad, etc.).
- Participants having access to Wi-Fi at home- or on the phone for downloading the app.
- Parenteral consent is required for an adolescent to participate in this study; simultaneously, an individual's consent is equally important to be included in this trial.
- Moreover, students will be asked to participate in the study if they:(a) experience mild to moderate depression defined as scoring above the cut-off score of 4 on the Patient Health Questionnaire for adolescents (PHQ-A) and/or anxiety symptoms defined as scoring above the cut-off score of 5 on the Generalized Anxiety Disorder scale-7 items (GAD-7 (b) had a well-being score of ≤50 on World Health Organization Well-Being scale (WHO-5) at basic screening level.
Who cannot join
- School authorities who did not grant permission to conduct the research study in their school
- School unable or unwilling to provide informed consent /assent
- students not willing to participate in the study
- Use of a mobile device that does not comply with the app requirements (non- android phone holders)
- Have no internet access or smartphone
- Students will be excluded if they: (a) any chronic disease (c) currently taking psychiatric consultation/ treatment for depression/ anxiety, or have received treatment/therapy in the past 12 months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Aga Khan University- Hospital
Karachi, Sindh, 75070
Shafquat Rozi, Ph D., +923002278976 ext. 4893, shafquat.rozi@aku.edu
Sana Qamar, Master, +923423727054, sana.qamar@aku.edu
About this study
Official title: Effectiveness of E-health Intervention Using Smart Phone App to Reduce Anxiety & Depressive Symptoms Among Adolescents: A Cluster Randomized Controlled Trial
the goal of this cluster randomized controlled trial is to assess the effectiveness of smartphone application in reducing the symptoms of Anxiety and depression among adolescents. The main objectives of this trial are:
- Primary Objective To develop a smart phone application for reduction in depressive and anxiety symptoms in Pakistani adolescents aged 12-18 years
- Secondary Objectives
Read more
- To determine the effectiveness of a smart phone application in reduction of anxiety symptoms in Pakistani adolescents aged 12-18 years via a randomized controlled trial
- To determine the effectiveness of a smart phone application in reduction of depressive symptoms in Pakistani adolescents aged 12-18 years via a randomized controlled trial
- To determine the effectiveness of a smart phone application in improvements of well-being of Pakistani adolescents aged 12-18 years via a randomized controlled trial the randomization will occur at the school level for the intervention group and control group.
Students in the intervention group will receive the access to a smartphone application designed to improve the mental health of adolescents, they will be briefed on how to use the application and its advantages. while the students in the control group will receive self-reading pictorial educational leaflets related to mental health improvement.
the researcher will conduct the assessment of depression, anxiety and mental wellbeing using PHQ-A, GAD-7 and WHO-5 at baseline, 1 month and at 3 months to compare if the smartphone application is effective in reducing the symptoms of depression and anxiety of adolescents and overall improvement in the mental wellbeing.
Read the detailed description
As per World Health Organization (WHO), 13% of adolescents worldwide experience a mental disorder. Also, depression, anxiety, and other behavioral disorders are leading causes of mortality and disability in this age bracket. The advent of the pandemic has further worsened the mental health situation in adolescents. If the increasing burden of mental health issues is not addressed in adolescence, they can culminate into established mental disorders extending to adulthood, impairing overall wellbeing and limiting opportunities. In order to cater to mental health issues in adolescents at an early stage, we aim to develop a smartphone application for the reduction of depression and anxiety symptoms in school-going adolescents aged 12-18 years.
Also, we plan to assess the effectiveness of the smartphone application via a cluster randomized controlled trial. The curated smartphone application will have two modules: Chill zone and sleep; Chill zone will comprise of 9 sub-modules and sleep 5 sub-modules. The 9 sub-modules of the Chill zone will be as follows; meditation, breathing techniques, family time, art time, funny sayings, reframe stress and relax, diet and cooking tips, mini-courses, and how to become better. The sub-modules of sleep will be winding down, sleep music, storytelling, nature sounds, and beautiful nature. Each module will be designed to be completed on separate days with daily push notifications.
Once the application is designed, the trial will be conducted in schools of Karachi. The intervention and control arm will have two schools with 50 students/school from grades 6-10. The total sample size will be 200 students. A two-stage cluster sampling with stratification on school type (government or private) will be employed to select schools and recruit students. Participants allocated to the intervention arm will be given mental health intervention, and the students in the control arm will be given educational leaflets. PHQ-A, GAD-7, and WHO depression wellbeing scale for assessing depressive symptoms, anxiety symptoms, and wellbeing will be used at baseline, 1 month, and three months. Generalized estimating equation, will be used to compare mean scores of depression, anxiety and wellbeing scores between both arms.
- Being tested
- A smartphone application, Pictorial educational leaflets
- Keywords
- Mental health, anxiety, depression, e-heath intervention, mental health application, adolescents
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A smartphone applicationOther
app will have 2 modules: Chill zone and sleep; Chill zone has 9 sub-modules which are meditation, breathing techniques, family time, art time, funny sayings, reframe stress and relax, diet and cooking tips, mini courses and how to become better. The sub-modules of sleep are: wind down, sleep music, storytelling, nature sounds and beautiful nature. These modules will be approved by a clinical psychologist to help people with symptoms of depression and anxiety. Skills learned include emotion recognition, emotional management, behavioral activation (being active), recognizing and challenging unhelpful thoughts and cognitive restructuring to plan for their future.
Pictorial educational leafletsOther
the control group will receive self-reading educational leaflets, the majority of which are pictorial. These leaflets will be approved by a clinical psychologist to help people with symptoms of depression and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | One public and one private school will be randomly placed into intervention arm. Students from grade 6th - grade 10th will be recruited on their willingness to participant.
A smartphone application will be installed on the personal gadgets of the students in the interventional arm at baseline. For assessing the effectiveness of this app, the first follow-up will be done at one month after the intervention and the second follow up after 3 months to evaluate whether the application had an impact on their depressive and anxiety symptom using PHQ-A, GAD-7 and WHO-5 scales. Receives: Other: A smartphone application |
| control arm | Active comparator | one public and one private school will be randomly allocated to control arm. Students from grade 6th - grade 10th will be recruited on their willingness to participant.
the control group will receive self-reading educational leaflets. the first follow-up will be done at one month after the intervention and the second follow up after 3 months to evaluated whether the application had an impact on their depressive and anxiety symptom using PHQ-A, GAD-7 and WHO-5 scales. Receives: Other: Pictorial educational leaflets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
change in the level of anxiety symptoms using the Generalized anxiety scale (GAD-7)
Measured: 6 months
Depression
Change in the level of depressive symptoms assessed using Patient Health Questionnaire (PHQ-A) adapted for adolescents
Measured: 6 months
Mental well-being
change in the mental well-being scores assessed using WHO-5 scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-stage cluster sampling will be employed. Randomization will occur at school level for 2 arms i.e. interventional and control groups. Students will be selected randomly from each group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shafquat Rozi, Aga Khan University
- Investigators
- Shafquat Rozi, Ph D., Principal investigator, Aga Khan Hospital -Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865834
- Sponsor's protocol ID
- 8053
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balaji M, Andrews T, Andrew G, Patel V. The acceptability, feasibility, and effectiveness of a population-based intervention to promote youth health: an exploratory study in Goa, India. J Adolesc Health. 2011 May;48(5):453-60. doi: 10.1016/j.jadohealth.2010.07.029. Epub 2010 Oct 2.
PubMed 21501803Dawson KS, Watts S, Carswell K, Shehadeh MH, Jordans MJD, Bryant RA, Miller KE, Malik A, Brown FL, Servili C, van Ommeren M. Improving access to evidence-based interventions for young adolescents: Early Adolescent Skills for Emotions (EASE). World Psychiatry. 2019 Feb;18(1):105-107. doi: 10.1002/wps.20594. No abstract available.
PubMed 30600639Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: a randomized controlled clinical trial. Behav Res Ther. 2013 Jul;51(7):344-51. doi: 10.1016/j.brat.2013.03.003. Epub 2013 Mar 28.
PubMed 23639300de Bruin EJ, Bogels SM, Oort FJ, Meijer AM. Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition. Sleep. 2015 Dec 1;38(12):1913-26. doi: 10.5665/sleep.5240.
PubMed 26158889Gao Y, Li LP, Kim JH, Congdon N, Lau J, Griffiths S. The impact of parental migration on health status and health behaviours among left behind adolescent school children in China. BMC Public Health. 2010 Feb 3;10:56. doi: 10.1186/1471-2458-10-56.
PubMed 20128901Ha T, van Roekel E, Iida M, Kornienko O, Engels RCME, Kuntsche E. Depressive Symptoms Amplify Emotional Reactivity to Daily Perceptions of Peer Rejection in Adolescence. J Youth Adolesc. 2019 Nov;48(11):2152-2164. doi: 10.1007/s10964-019-01146-4. Epub 2019 Oct 16.
PubMed 31620972Hellfeldt K, Lopez-Romero L, Andershed H. Cyberbullying and Psychological Well-being in Young Adolescence: The Potential Protective Mediation Effects of Social Support from Family, Friends, and Teachers. Int J Environ Res Public Health. 2019 Dec 19;17(1):45. doi: 10.3390/ijerph17010045.
PubMed 31861641Karyotaki E, Klein AM, Riper H, Wit L, Krijnen L, Bol E, Bolinski F, Burger S, Ebert DD, Auerbach RP, Kessler RC, Bruffaerts R, Batelaan N, van der Heijde CM, Vonk P, Kleiboer A, Wiers RW, Cuijpers P. Examining the effectiveness of a web-based intervention for symptoms of depression and anxiety in college students: study protocol of a randomised controlled trial. BMJ Open. 2019 May 14;9(5):e028739. doi: 10.1136/bmjopen-2018-028739.
PubMed 31092668Khalid A, Qadir F, Chan SWY, Schwannauer M. Adolescents' mental health and well-being in developing countries: a cross-sectional survey from Pakistan. J Ment Health. 2019 Aug;28(4):389-396. doi: 10.1080/09638237.2018.1521919. Epub 2018 Nov 19.
PubMed 30451053Mason-Jones AJ, Crisp C, Momberg M, Koech J, De Koker P, Mathews C. A systematic review of the role of school-based healthcare in adolescent sexual, reproductive, and mental health. Syst Rev. 2012 Oct 26;1:49. doi: 10.1186/2046-4053-1-49.
PubMed 23098138Moore SE, Norman RE, Suetani S, Thomas HJ, Sly PD, Scott JG. Consequences of bullying victimization in childhood and adolescence: A systematic review and meta-analysis. World J Psychiatry. 2017 Mar 22;7(1):60-76. doi: 10.5498/wjp.v7.i1.60. eCollection 2017 Mar 22.
PubMed 28401049Rao S, Shah N, Jawed N, Inam S, Shafique K. Nutritional and lifestyle risk behaviors and their association with mental health and violence among Pakistani adolescents: results from the National Survey of 4583 individuals. BMC Public Health. 2015 Apr 28;15:431. doi: 10.1186/s12889-015-1762-x.
PubMed 25927931Razzak HA, Harbi A, Ahli S. Depression: Prevalence and Associated Risk Factors in the United Arab Emirates. Oman Med J. 2019 Jul;34(4):274-282. doi: 10.5001/omj.2019.56.
PubMed 31360314Salam RA, Das JK, Lassi ZS, Bhutta ZA. Adolescent Health and Well-Being: Background and Methodology for Review of Potential Interventions. J Adolesc Health. 2016 Oct;59(4S):S4-S10. doi: 10.1016/j.jadohealth.2016.07.023.
PubMed 27664594van Dalen M, Dierckx B, Pasmans SGMA, Aendekerk EWC, Mathijssen IMJ, Koudstaal MJ, Timman R, Williamson H, Hillegers MHJ, Utens EMWJ, Okkerse JME. Anxiety and depression in adolescents with a visible difference: A systematic review and meta-analysis. Body Image. 2020 Jun;33:38-46. doi: 10.1016/j.bodyim.2020.02.006. Epub 2020 Feb 21.
PubMed 32092507
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of E-health Intervention Using Smart Phone App to Reduce Anxiety & Depressive Symptoms Among Adolescents: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05865834
- Acronym / sponsor ID
- 8053
- Keywords
- Mental health, anxiety, depression, e-heath intervention, mental health application, adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 19 May 2023 (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.
the goal of this cluster randomized controlled trial is to assess the effectiveness of smartphone application in reducing the symptoms of Anxiety and depression among adolescents. The main objectives of this trial are:
- Primary Objective To develop a smart phone application for reduction in depressive and anxiety symptoms in Pakistani adolescents aged 12-18 years
- Secondary Objectives
- To determine the effectiveness of a smart phone application in reduction of anxiety symptoms in Pakistani adolescents aged 12-18 years via a randomized controlled trial
- To determine the effectiveness of a smart phone application in reduction of depressive symptoms in Pakistani adolescents aged 12-18 years via a randomized controlled trial
- To determine the effectiveness of a smart phone application in improvements of well-being of Pakistani adolescents aged 12-18 years via a randomized controlled trial the randomization will occur at the school level for the intervention group and control group.
Students in the intervention group will receive the access to a smartphone application designed to improve the mental health of adolescents, they will be briefed on how to use the application and its advantages. while the students in the control group will receive self-reading pictorial educational leaflets related to mental health improvement.
the researcher will conduct the assessment of depression, anxiety and mental wellbeing using PHQ-A, GAD-7 and WHO-5 at baseline, 1 month and at 3 months to compare if the smartphone application is effective in reducing the symptoms of depression and anxiety of adolescents and overall improvement in the mental wellbeing.
Detailed description
As per World Health Organization (WHO), 13% of adolescents worldwide experience a mental disorder. Also, depression, anxiety, and other behavioral disorders are leading causes of mortality and disability in this age bracket. The advent of the pandemic has further worsened the mental health situation in adolescents. If the increasing burden of mental health issues is not addressed in adolescence, they can culminate into established mental disorders extending to adulthood, impairing overall wellbeing and limiting opportunities. In order to cater to mental health issues in adolescents at an early stage, we aim to develop a smartphone application for the reduction of depression and anxiety symptoms in school-going adolescents aged 12-18 years.
Also, we plan to assess the effectiveness of the smartphone application via a cluster randomized controlled trial. The curated smartphone application will have two modules: Chill zone and sleep; Chill zone will comprise of 9 sub-modules and sleep 5 sub-modules. The 9 sub-modules of the Chill zone will be as follows; meditation, breathing techniques, family time, art time, funny sayings, reframe stress and relax, diet and cooking tips, mini-courses, and how to become better. The sub-modules of sleep will be winding down, sleep music, storytelling, nature sounds, and beautiful nature. Each module will be designed to be completed on separate days with daily push notifications.
Once the application is designed, the trial will be conducted in schools of Karachi. The intervention and control arm will have two schools with 50 students/school from grades 6-10. The total sample size will be 200 students. A two-stage cluster sampling with stratification on school type (government or private) will be employed to select schools and recruit students. Participants allocated to the intervention arm will be given mental health intervention, and the students in the control arm will be given educational leaflets. PHQ-A, GAD-7, and WHO depression wellbeing scale for assessing depressive symptoms, anxiety symptoms, and wellbeing will be used at baseline, 1 month, and three months. Generalized estimating equation, will be used to compare mean scores of depression, anxiety and wellbeing scores between both arms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-stage cluster sampling will be employed. Randomization will occur at school level for 2 arms i.e. interventional and control groups. Students will be selected randomly from each group
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Other: A smartphone applicationOne public and one private school will be randomly placed into intervention arm. Students from grade 6th - grade 10th will be recruited on their willingness to participant. A smartphone application will be installed on the personal gadgets of the students in the interventional arm at baseline. For assessing the effectiveness of this app, the first follow-up will be done at one month after the intervention and the second follow up after 3 months to evaluate whether the application had an impact on their depressive and anxiety symptom using PHQ-A, GAD-7 and WHO-5 scales. |
| control arm | Active comparator | Other: Pictorial educational leafletsone public and one private school will be randomly allocated to control arm. Students from grade 6th - grade 10th will be recruited on their willingness to participant. the control group will receive self-reading educational leaflets. the first follow-up will be done at one month after the intervention and the second follow up after 3 months to evaluated whether the application had an impact on their depressive and anxiety symptom using PHQ-A, GAD-7 and WHO-5 scales. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Registered secondary schools with the Board of Secondary Education Karachi who will provide consent to participate in the study
- 12-18-year-olds adolescents enrolled in public and private school of Karachi Pakistani
- The intervention and control arm must understand English or Urdu in order to use the mobile-based application.
- Intervention group must have access to a smartphone or portable smart device (Electronic Tablets, iPad, etc.).
- Participants having access to Wi-Fi at home- or on the phone for downloading the app.
Key exclusion criteria (6 listed)
- School authorities who did not grant permission to conduct the research study in their school
- School unable or unwilling to provide informed consent /assent
- students not willing to participate in the study
- Use of a mobile device that does not comply with the app requirements (non- android phone holders)
- Have no internet access or smartphone
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 |
|---|---|---|
| A smartphone applicationapp will have 2 modules: Chill zone and sleep; Chill zone has 9 sub-modules which are meditation, breathing techniques, family time, art time, funny sayings, reframe stress and relax, diet and cooking tips, mini courses and how to become better. The sub-modules of sleep are: wind down, sleep music, storytelling, nature sounds and beautiful nature. These modules will be approved by a clinical psychologist to help people with symptoms of depression and anxiety. Skills learned include emotion recognition, emotional management, behavioral activation (being active), recognizing and challenging unhelpful thoughts and cognitive restructuring to plan for their future. | Other | intervention arm |
| Pictorial educational leafletsthe control group will receive self-reading educational leaflets, the majority of which are pictorial. These leaflets will be approved by a clinical psychologist to help people with symptoms of depression and anxiety. | Other | control arm |
Primary outcome
Anxiety
Time frame: 6 months
change in the level of anxiety symptoms using the Generalized anxiety scale (GAD-7)
Depression
Time frame: 6 months
Change in the level of depressive symptoms assessed using Patient Health Questionnaire (PHQ-A) adapted for adolescents
Mental well-being
Time frame: 6 months
change in the mental well-being scores assessed using WHO-5 scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Background: PubMed 21501803Balaji M, Andrews T, Andrew G, Patel V. The acceptability, feasibility, and effectiveness of a population-based intervention to promote youth health: an exploratory study in Goa, India. J Adolesc Health. 2011 May;48(5):453-60. doi: 10.1016/j.jadohealth.2010.07.029. Epub 2010 Oct 2.
- Background: PubMed 30600639Dawson KS, Watts S, Carswell K, Shehadeh MH, Jordans MJD, Bryant RA, Miller KE, Malik A, Brown FL, Servili C, van Ommeren M. Improving access to evidence-based interventions for young adolescents: Early Adolescent Skills for Emotions (EASE). World Psychiatry. 2019 Feb;18(1):105-107. doi: 10.1002/wps.20594. No abstract available.
- Background: PubMed 23639300Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: a randomized controlled clinical trial. Behav Res Ther. 2013 Jul;51(7):344-51. doi: 10.1016/j.brat.2013.03.003. Epub 2013 Mar 28.
- Background: PubMed 26158889de Bruin EJ, Bogels SM, Oort FJ, Meijer AM. Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition. Sleep. 2015 Dec 1;38(12):1913-26. doi: 10.5665/sleep.5240.
- Background: PubMed 20128901Gao Y, Li LP, Kim JH, Congdon N, Lau J, Griffiths S. The impact of parental migration on health status and health behaviours among left behind adolescent school children in China. BMC Public Health. 2010 Feb 3;10:56. doi: 10.1186/1471-2458-10-56.
- Background: PubMed 31620972Ha T, van Roekel E, Iida M, Kornienko O, Engels RCME, Kuntsche E. Depressive Symptoms Amplify Emotional Reactivity to Daily Perceptions of Peer Rejection in Adolescence. J Youth Adolesc. 2019 Nov;48(11):2152-2164. doi: 10.1007/s10964-019-01146-4. Epub 2019 Oct 16.
- Background: PubMed 31861641Hellfeldt K, Lopez-Romero L, Andershed H. Cyberbullying and Psychological Well-being in Young Adolescence: The Potential Protective Mediation Effects of Social Support from Family, Friends, and Teachers. Int J Environ Res Public Health. 2019 Dec 19;17(1):45. doi: 10.3390/ijerph17010045.
- Background: PubMed 31092668Karyotaki E, Klein AM, Riper H, Wit L, Krijnen L, Bol E, Bolinski F, Burger S, Ebert DD, Auerbach RP, Kessler RC, Bruffaerts R, Batelaan N, van der Heijde CM, Vonk P, Kleiboer A, Wiers RW, Cuijpers P. Examining the effectiveness of a web-based intervention for symptoms of depression and anxiety in college students: study protocol of a randomised controlled trial. BMJ Open. 2019 May 14;9(5):e028739. doi: 10.1136/bmjopen-2018-028739.
- Background: PubMed 30451053Khalid A, Qadir F, Chan SWY, Schwannauer M. Adolescents' mental health and well-being in developing countries: a cross-sectional survey from Pakistan. J Ment Health. 2019 Aug;28(4):389-396. doi: 10.1080/09638237.2018.1521919. Epub 2018 Nov 19.
- Background: PubMed 23098138Mason-Jones AJ, Crisp C, Momberg M, Koech J, De Koker P, Mathews C. A systematic review of the role of school-based healthcare in adolescent sexual, reproductive, and mental health. Syst Rev. 2012 Oct 26;1:49. doi: 10.1186/2046-4053-1-49.
- Background: PubMed 28401049Moore SE, Norman RE, Suetani S, Thomas HJ, Sly PD, Scott JG. Consequences of bullying victimization in childhood and adolescence: A systematic review and meta-analysis. World J Psychiatry. 2017 Mar 22;7(1):60-76. doi: 10.5498/wjp.v7.i1.60. eCollection 2017 Mar 22.
- Background: PubMed 25927931Rao S, Shah N, Jawed N, Inam S, Shafique K. Nutritional and lifestyle risk behaviors and their association with mental health and violence among Pakistani adolescents: results from the National Survey of 4583 individuals. BMC Public Health. 2015 Apr 28;15:431. doi: 10.1186/s12889-015-1762-x.
- 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.
Shafquat Rozi, Ph D. principal investigator
Aga Khan Hospital -Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A smartphone application and Pictorial educational leaflets in people with Mental Disorder in Adolescence and Depression in Adolescence, run by Aga Khan University at 1 site in Pakistan.
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 6 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: status not confirmed, as of the sponsor's last update on 19 May 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shafquat Rozi, Ph.D. (+92 300 2278976 ext. 4893, shafquat.rozi@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT05865834, which also lists 17 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 19 May 2023.