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| Name | Class |
|---|---|
| Fatima Jinnah Women University | OTHER |
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Mental health problems are amongst the major contributors to disease burden globally.
According to a recent study, 34% of young people worldwide (aged 10-19) suffer from depression and more than half of this population belongs to Southeast Asia such as Pakistan, India, and China.
Existing evidence shows that the access to mental health services in LMICs is limited and even fewer child psychiatric services are available.
One approach to overcome barriers such as limited availability of trained mental health professionals and risk of stigma may involve the use of simple, brief, scalable interventions based on basic psychological principles rather than treatment of psychopathology.
This study adapts and evaluates two brief interventions called behavioral activation single session intervention (BA-SSI) and 4-session Mindset intervention (MI) for teenage depression and anxiety in Pakistan, where access to mental health care is constrained by societal stigma and a shortage of clinicians.
A 3-arm multi-center cluster exploratory Randomized Controlled Trial to determine the feasibility, acceptability and preliminary effectiveness of a universally delivered, culturally adapted, potentially low cost, 4-session Mindset intervention (MI) and behavioral activation single session intervention (BA-SSI) for school going young persons (YP) (12-15 years) in Pakistan.
Proposed study is designed using the updated Medical Research Council (MRC) Framework for the development and evaluation of complex interventions.
Three public schools will be recruited from each of 10 cities across Pakistan: Karachi, Hyderabad, Nawabshah, Thatta, Lahore, Gujrat, Rawalpindi, Multan, Quetta, and Peshawar.
All the participants, regardless of their treatment arm, will be assessed at baseline, 1 month post-baseline and at 3-month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation - single session intervention (BA-SSI) | Experimental | This is comprised of 5 five components:
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| 4-session Mindset intervention | Active Comparator | This is comprised of a growth mindset module (2 sessions), a gratitude module (1 session) and a value affirmations module (1 session). Sessions are delivered weekly (over 4 weeks) and each session lasts for an hour. Reading and writing activities and group discussions are included in each session. Participants are supposed to complete homework exercises are assigned between sessions. |
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| Waiting list control group | No Intervention | At end of the study, this group will be offered to choose one intervention from two active interventions mentioned above. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation - single session intervention (BA-SSI) | Behavioral | Single session intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of recruitment | This will be monitored through a research trial log. This log will include information about number of schools approached, number of schools eligible to participate, number of schools consented to participate, number of YP approached, number of eligible YP and number of those who consented to participate | Total recruitment period is 3 months. Change in numbers will be recorded from first month of recruitment to 3rd month of recruitment |
| Feasibility of intervention | Session attendance for each participant in active study arms for each session will be recorded and maintained in participant intervention log. | Retention of participants in the Intervention at the completion of one month intervention period. |
| Depression | The Patient Health Questionnaire -8 will be used to assess the symptoms of depression. PHQ-8 scores are highly correlated with PHQ-9 scores, and the same cutoffs can be used to assess depression severity | Change in scores from baseline to 3-month follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| The Revised Child Anxiety and Depression Scale | It is a 47-item, youth self-report questionnaire with subscales including: separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major depressive disorder (MDD). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Items are rated on a 4-point Likert-scale from 0 ("never") to 3 ("always"). |
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Young persons (YP)
Inclusion Criteria:
Exclusion Criteria:
Schools Inclusion Criteria
Schools in the study areas are eligible to participate if they meet all the following criteria:
If the school meet the following exclusion criteria, they are ineligible to participate:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tayyeba Kiran, PhD | Contact | 0923328262142 | tayyebakiran@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public school for boys 1 | Rawalpindi | Punjab Province | Pakistan |
This is the feasibility study and interventions will continue to refine and adapt. The IP is owned by the Pakistan Institute of Living and Learning
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Three arm study. Schools would be the unit of cluster.
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| 4-session Mindset intervention | Behavioral | This is comprised of 4 sessions. |
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| Change in scores from baseline to 3-month follow up |
| Growth Mindset scale | The mindset scale is comprised of 3 items regarding participants' views about the mindset such as intelligence, personality etc. There is not cutoff score. Higher total summed scores indicate stronger fixed mindsets, and lower scores, stronger growth mindsets. | Change in scores from baseline to 3-month follow up |
| Beck's hopelessness Scale short version | A 4-item short version of the Hopelessness Scale includes all the affective, cognitive and motivational components of hopelessness. | Change in scores from baseline to 3-month follow up |
| EuroQol Quality of Life scale | This scale provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. higher score indicare greater disability. there is no cutoff score. | Change in scores from baseline to 3-month follow up |
| Program Feedback Scale | youths will be asked to complete a series of questions regarding their experience with the intervention to which they were assigned. highre score will indicate greater level of acceptability. there is no cut off score. | Total acceptability score at completion of one month intervention period. |