Study design and settings
This study is a cluster randomized control trial. Clusters are defined as randomly selected public or private schools of Karachi, Pakistan which will be randomized to the intervention and the control arm. Karachi is a home to people belonging various cultures, ethnicities and socioeconomic classes which makes it a feasible study setting.
Study Population:
The target population is school-going adolescents (boys and girls) of Karachi from grades 6 to 10 and aged between 12–18 years and having access to smartphones. Recruitment of participating schools is based on their willingness to participate in the study.
Eligibility Criteria for schools
Exclusion:
Eligibility criteria for participants
Inclusion:
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Ability to understand and comprehend English or Urdu language
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Participants randomized to the intervention arm should have regular/daily access to smart phones or portable device compatible with the application. Smart phones or devices can be personal or shared.
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Provision of wifi or internet data/ effective internet connection.
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Participant assent/consent as well as parental consent.
Exclusion:
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Diagnosed mental health condition.
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Current/history of use of psychiatric medications.
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Recent acute illness.
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Presence of chronic illness.
Sample Size
An estimated sample size of 200 school going adolescents was obtained in intervention and control arm by sampling 2 clusters in each arm with 50 adolescents in each cluster to achieve 80% power. The intraclass correlation coefficient of 0.02 and the coefficient of variation of cluster sizes is 0.650 were assumed. The mean difference of 2.74 in depression score between intervention and control group was assumed under the null hypothesis with the standard deviation of subjects is 0.70. The sample size was estimated to conduct cluster randomized controlled trial using NCSS PASS version 15 software. The sample size was also estimated for other outcomes. However, the largest sample size was selected.
Sampling strategy
A two-stage cluster sampling with stratification on school type (government or private) will be employed for the selection of schools and recruitment of students within schools of Karachi city. A 1:1 ratio of public / private schools will be selected. A line listing of the schools will be curated from different districts of Karachi and public and private schools fulfilling the eligibility criteria will be recruited. Each school will act as a cluster and will be randomized to the intervention and the control arm. Listing of eligible students will be done and then they will be randomly selected for the study.
Randomization
Randomization will be performed through a computer-generated sequence using SPSS. The schools will then be assigned as the control and intervention arms via computerized randomization. To avoid contamination between clusters, schools will be selected in separate districts. Students of grade 6–10 will be randomly selected through simple random selection from each cluster (schools) and will be invited to participate in the study.
Participant recruitment and Data Collection
The data collection of the study will start in October 2023, As the designing, curation and testing of the application will take 6 months that is till September 2023, schools will be randomized to intervention and control arm. Participants will be screened for eligibility and eligible participants will be randomly selected for the study (Fig. 1). Informed assent and parental consent will be taken from participants under 18 years of age and participant consent will be taken from participants 18 years of age. Consent and assent is curated in both English and Urdu languages and will be administered to the participants after the research associate explain the entire study to them. Prior to the beginning of the study, parents will be briefed about the study at any parent teacher meeting. If the participant agrees to be the part of the study, contact details of the parents will be obtained. Verbal informed consent will be administered to the parents along with the written copy for signature will be sent to them via the participant. A copy of assent/ participant consent and parental consent will be given to participants and parents for their record. After the assent/consent and parental consent is taken, participants will be administered a self-reported questionnaire asking details about socio-demographics: age, contact details, area of residence, grade, school, education, and employment status of parents, siblings, school, medium of instruction, options of commute, access to internet/smart devices. Besides personality traits, neighborhood, number of good friends, school connectedness, dietary habits, smoking/drug use, daily routine, extra-curricular activities, grades will also be noted. To assess depression and anxiety symptomatology as well as overall well-being, Primary Health Questionnaire-A (PHQ A), Generalized Anxiety Disorder-7 (GAD-7) and WHO-5 tools will be administered by the research associate. The screening of participants for depression and anxiety symptoms as well as overall wellbeing will be done at baseline and on follow-ups to assess the effectiveness of the intervention.
Following the baseline screening, participants in the intervention group will be acquainted and trained on the usage of the application whereas participants in the control arm will be given age and context relevant leaflets based on mental health. Participants in both arms will be followed for one month and six months and PHQ-A, GAD-7 and WHO-5 will be administered again to assess the change. Follow-up visits will be in schools by the research team and administration of the tools will be in person.
Intervention group
After baseline assessment, the screening scales will provide us with eligible students for the intervention group in the school. We will demonstrate the intervention for the participants and provide with installation and access details of the app. To avoid discrimination between students who have and those who do not have anxiety and depressive symptoms, the application will be installed on their gadgets.
The mobile application has 2 modules: Calm zone and Challenge yourself. Calm zone has 6sub-modules and Challenge yourself has 3 sub-modules. The 6 sub-modules of Calm zone are as follows; sleep soundly, feel calm and relax, manage my worries, being present and mindful, building happiness and healthy habits and something else. The Calm zone serves as a dedicated space for the adolescents to find solace, tranquility and emotional regulation. Through a curated collection of mindful exercises, relaxation techniques and guided meditation, the calm zone aims to empower adolescents with invaluable tools to navigate their emotions, build resilience and foster a positive mindset. The sub-modules of Challenge yourself are: take up daily challenge, challenge your negative thought and make belief experiment. These modules will be approved by a clinical psychologist to help people with symptoms of depression and anxiety.
Each module is designed to be completed with daily push-notifications send to the student to promote interest of the users, and users are encouraged to follow these modules. Participants will complete the program on their personal smartphones, in their own time or in class time if schools wish to offer it. Skills learned through this program include emotion recognition, emotional management, behavioral activation (being active), recognizing and challenging unhelpful thoughts and cognitive restructuring to plan for their future.
There will be two scheduled follow ups for assessing the effectiveness of this app, the first follow-up will be done at 4 weeks after the intervention and the second follow up after3 months and then they will be evaluated at each visit whether the application had an impact on their depressive and anxiety symptom using PHQ-A, GAD-7 and WHO-5 scales. This is combined with adherence to intervention which is measured by tracking the app usage automatically; by data related to the total number of modules completed, time spent per module and number of logging into the platform are gathered.
Control Group
After baseline assessment, and parental/guardian consent, we will educate the participants about the study and provide the selected students with age and context relevant mental health brochures.
The students in 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. They are designed with attractive colors and simple language (English or Urdu) in a comprehensible way which gauges the interest of the participants. Not only this, but the pamphlets explain anxiety and depression and overall mental wellbeing of young adults(teens), and provides valuable advice on how to cope with negative thoughts and overcome anxiety.
Follow-up will be done after 4 weeks (1 month) of the initial dispensation of the literature, and then after 3 months. The follow up includes assessment via PHQ-A, GAD-7 and WHO-5 scales to evaluate any changes observed in depressive or anxiety symptoms.
Assessment tools
Patient Health Questionnaire-Adolescent (PHQ-A)
The PHQ-A is a self-report outcome measure that can be used to screen depressive symptoms.
It is a Severity Measure for Depression—Child Age 11–17 (adapted from PHQ-9 modified for Adolescents [PHQ-A]). Each item on the measure is rated on a 4-point scale (0 = Not at all; 1 = Several days; 2 = More than half the days; and 3 = Nearly every day). The total score can range from 0 to 27, with higher scores indicate greater severity of depression. The PHQ-A study has the highest positive predictive value with a reported sensitivity of 73% and specificity of 94% for a positive test result (14) and a cut-off value of 10 (15) is utilized in this study. It is validated in multiple countries including Pakistan (Cronbach's alpha 0.76) (16, 17). This scale can be categorized into five categories based on level of severity “none (0–4), mild (5–9), moderate (10–14), moderately severed (15–19), and severe (20–27)”
Generalized Anxiety Disorder scale
The 7-item GAD scale will be used to measure symptoms of anxiety. Each of the 7 items is scored on a 0–3 scale while total score range is 0–21. The GAD-7 requires approximately 1–2 minutes to administer and for each symptom queried provides the following response options: “not at all,” “several days,” “over half the days” and “nearly every day” and these are scored, respectively, as 0, 1, 2 or 3.A cut-off value of 5 is used to gauge anxiety in the participant, higher scores indicate more severe anxiety symptoms. It is validated in multiple countries including Pakistan (Cronbach's alpha 0.83) (18)
Well-being WHO-5
This scale has 5 items and is used to gauge the effect of mindfulness and wellbeing of the participants. The score ranges from 0–25, which is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing best possible quality of life. (19).
Sociodemographic characteristics:
Information on- age, gender, grade level, body mass index, education, ethnicity, language spoken at home, who they live with at home, and socioeconomic status such as family structure, father’s occupation, family’s monthly income, any comorbid condition such as heart problems, psychological or neurological problems in the participant or in the participant’s family will also be noted. A number of other covariates will be included: school factors (close friendships, missing school without permission, peer relationship, bullying incidents and safety of students within school premises, change of school), health factors (physical activity, substance use, fruits and vegetable consumption, junk food consumption, personal hygiene, past severe trauma/ injury) and family factors (parental involvement, family’s substance use, parent-child relationship).
Data Management:
Editing, Entry and Cleaning of Data
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Data editing- editing will be done by data collectors and study coordinator with different colored pens daily after collection of the data, questionnaire will be checked thoroughly for completeness, logical data entries and consistency. Every form will be evaluated for any missing/ inappropriate and will be corrected on spot during the data collection visit. To attain an accurate data entry process, PI will carry out the final editing of the data after completing the entire data collection.
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Data entry- data will be entered in to the computer using EPI-Info software; version 7. (77) Two data entry operators will double enter the data and to ensure its validity, files will be compared and rechecked .The study coordinator will conduct training on data entry to avoid any punching errors either by the data collectors. Correction will be made by referring to the particular questionnaire. Data will then be exported to STATA.
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Data cleaning- will be done to examine the text carefully, and to detect any error and wild codes entries. Frequency distribution tables (range checks) will be generated for each variable for the assessment of the outliers by the PI. Logical consistency for the interconnected questions will be checked by the cross tabulation of the data b/w interconnected variables
Data Confidentiality and storage
Questionnaires will have study code number; however, the names and addresses of the study participants will be noted on separate sheets which will later be discarded after data analysis. Filled questionnaires will be stored in locked cabinets, only accessible to authorized principle investigator, data might be shared with the ethical review committee of AKUH upon their request. If the study is published in a journal, the names of the participants will be kept confidential and any other information that may lead to disclosure of the participant’s identity. As per the AKUH policy, the questionnaires are intended to be stored for 5 years after the study has completed and electronic data for 7 years.
Quality Assurance
For quality assurance study personnel will be provided with a manual of operation to standardize all the procedures. To ensure the validity of the translated questionnaire, data collector will fill at least 10 forms in the presence of the principle investigator during the initial phase of the study to observe their approach and familiarity about the data collection. Also the principle investigator will make random field visit to observe the process of examination and data collection and the reliability of the information that is being gathered. Data editing will be done both at the field and at office site to further ensure the quality control.
Questionnaire will be cross checked for reasonable sequencing and consistency. Double data set entered by the data collectors will be compared for consistencies and completeness
Method of analysis
Analysis will be done using STATA version 18.0. Mean with standard deviation will be reported for symmetrically distributed quantitative variables. Median and interquartile ranges will be reported for asymmetrically distributed variables. Frequency and percentages will be reported for qualitative variables.
We will calculate mean reduction in anxiety and depression score of adolescents. T-test for two independent samples will be used to compare anxiety and depression score of intervention group with control group. Paired t-test will be used to assess significance of mean reduction in anxiety and depression score from the baseline in both the groups. Same methods will be used to compare wellbeing scores and knowledge scores for management anxiety and depression from baseline and before and after.
To assess and compare the effectiveness of a smartphone app and leaflet and taking the clustering structure of the data into account Generalized Estimating Equation (GEE) will be used to compare the anxiety, depression, wellbeing, and knowledge score. We will also assess the factors associated with reduction in depression and anxiety symptoms. The regression coefficients along with 95% confidence will be reported for significant factors.
Ethical approval
This protocol has been developed following the Standard Protocol Items: Recommendations for Interventional Trials SPIRIT guidelines for streamlining the development and reporting of trial protocol and the extension of the Consolidated Standards of Reporting Trials (CONSORT) for randomized pilot and feasibility trials.
Ethical approval from Ethical Review Committee at Aga Khan University is obtained ERC ref # 2022-8053-23595. Additional approval from school authority after explaining the purpose of the study and confidentiality of the school name and student’s personal details will be guaranteed. Written informed consent from all participating schools will be mandatory, and students’ participation will be voluntary. Parents will be informed by schools with a note that their children will participate in the study related to anxiety, depression, and wellbeing intervention using mobile phone application which will require internet access. The teaching materials and the mobile app will be reviewed and approved by the school’s management, and parents will have the authority to withdraw their children from the study at any point in time. This trial is registered in the ClinicalTrials.gov registry. The academic schedule of the students will be taken into account and interviews will be conducted during recess/lunch time or during free periods within school hours.
Public health implications: Pandemic has triggered and initiated a plethora of mental health issues predominantly in adolescents due to lock downs, fear of uncertainty and closure of schools. The mental health issues at the time of the pandemic were not addressed appropriately and still persists in a lot of adolescents. If these symptoms are not now proactively addressed they will culminate into established mental health disorders which will effect long term productivity and goals of these individuals. This application by addressing mental health symptoms in adolescents will benefit the community at large by limiting the burden of mental health disorders. Also, this will eliminate the chances of stigmatization and will be a cost effective way to address mental health concerns in an underprivileged strata of society as the application comes without any cost. This application will improve accessibility especially in adolescents experiencing financial constraints such as lack of money or transportation to attend appointments. Schools by permitting conduct of this study in their schools will play a huge role in generating the evidence base backing this study. Also, by improving the mental health of students, their results and academic performance will improve, consequently benefitting the school. There are hardly any programs in Pakistan that focus on mHealth interventions that are tailored and target anxiety and depression among adolescents. This smartphone application will stimulate autonomous motivation in adolescents by integrating all the components based on the perspectives of Pakistani adolescents. The smartphone application, due to its user- friendly interface, the interactive and multilingual approach, will be accessible and usable students. Studies have suggested that adolescents are very hesitant in communicating their issues verbally especially the sensitive topics, hence this application will help them in understanding and addressing their issues without any uncomfortable communication and fear of stigmatization. Also, they will be available without any cost so that is an added advantage.
Smartphone applications have the potential to improve access to mental health treatment and to positively impact clinical outcomes, however there is limited studies support the effectiveness of these applications for children, preadolescents, and adolescents with mental health problems (20). Applications targeted specifically for adolescents with different cultural backgrounds are very limited. As such, the majority of mental health apps available for download are not supported by evidence-based research and may not follow evidence-based treatment guidelines.
In a resource limited country like Pakistan with limited mental health infrastructure and deeply rooted mental health stigma, an mhealth application will open new doors by increasing reach and accessibility to mental health interventions. This smartphone application will be the first of its kind that will be designed to stimulate autonomous motivation in adolescents by integrating all the components based on the perspectives of Pakistani adolescents. Implementing this intervention in a school -based setting will be the cost effective way to reach the community without stigmatizing them. Adolescence is the most crucial stage as it is a transition to adulthood, hence mental health issues are most common in this phase, this application will help to substantially reduce the symptoms of anxiety and depression before they culminate into a full blown mental health disorder.
On a policy level, this research will promote the use of smart phone applications for public health issues such as mental health and in the future such applications can be extended to other health programmes. Also, clinicians can use such applications adjunct to their treatment strategies for better outcomes.