Distress, Emotional
Conditions
Keywords
adolescents, anxiety, depression, single session interventions, growth mindset, Pakistan
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBehavioral Activation - single session intervention (BA-SSI)
Single session intervention
BEHAVIORAL4-session Mindset intervention
This is comprised of 4 sessions.
Sponsors
Fatima Jinnah Women University
Pakistan Institute of Living and Learning
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Three arm study. Schools would be the unit of cluster.
Eligibility
Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
Young persons (YP) Inclusion Criteria: * Youth is between the age 12-15 years (inclusive) at the time of study enrollment. * Youth has one parent or legal guardian to give consent. * Youth speaks Urdu well enough to complete the paper based intervention.
Exclusion criteria
* Intellectual disability, as this may undermine comprehension of intervention material. * Adolescent with history of hospitalization or those who received inpatient treatment for a mental health problem within the past two months as the intervention being tested and this study is not designed for adolescent with acute medical and/or psychiatric treatment needs (if identified with any acute medical and/or psychiatric problem, they would be referred to appropriate health services through parents). Schools Inclusion Criteria Schools in the study areas are eligible to participate if they meet all the following criteria: 1. the school authority agrees to participate; 2. the schools shall be non-specialist public schools; 3. school contains at least 80 students;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of recruitment | Total recruitment period is 3 months. Change in numbers will be recorded from first month of recruitment to 3rd month 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 |
| Feasibility of intervention | Retention of participants in the Intervention at the completion of one month intervention period. | Session attendance for each participant in active study arms for each session will be recorded and maintained in participant intervention log. |
| Depression | Change in scores from baseline to 3-month follow up. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol Quality of Life scale | Change in scores from baseline to 3-month follow up | 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. |
| The Revised Child Anxiety and Depression Scale | Change in scores from baseline to 3-month follow up | 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). |
| Program Feedback Scale | Total acceptability score at completion of one month intervention period. | 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. |
| Growth Mindset scale | Change in scores from baseline to 3-month follow up | 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. |
| Beck's hopelessness Scale short version | Change in scores from baseline to 3-month follow up | A 4-item short version of the Hopelessness Scale includes all the affective, cognitive and motivational components of hopelessness. |
Countries
Pakistan
Contacts
Primary ContactTayyeba Kiran, PhD
Outcome results
None listed