Universally Delivered Interventions for Young People
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Behavioral Activation - single session intervention (BA-SSI), 4-session Mindset intervention.
- Who it may be relevant to
- Registry conditions: Distress, Emotional. Basic parameters: 12 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A 3-arm Multi-Center Exploratory Trial of Universally Delivered Interventions for Prevention of Anxiety and Depression in Young People in Pakistan
Overview
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
- Behavioral Behavioral Activation - single session intervention (BA-SSI)
Single session intervention - Behavioral 4-session Mindset intervention
This is comprised of 4 sessions.
Primary outcome measures
- Feasibility of recruitment [Time frame: 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 [Time frame: Retention of participants in the Intervention at the completion of one month intervention period.]
- Depression [Time frame: Change in scores from baseline to 3-month follow up.]
Secondary outcome measures (5)
- The Revised Child Anxiety and Depression Scale [Time frame: Change in scores from baseline to 3-month follow up]
- Growth Mindset scale [Time frame: Change in scores from baseline to 3-month follow up]
- Beck's hopelessness Scale short version [Time frame: Change in scores from baseline to 3-month follow up]
- EuroQol Quality of Life scale [Time frame: Change in scores from baseline to 3-month follow up]
- Program Feedback Scale [Time frame: Total acceptability score at completion of one month intervention period.]
Eligibility 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:
- the school authority agrees to participate;
- the schools shall be non-specialist public schools;
- school contains at least 80 students; Exclusion criteria
If the school meet the following exclusion criteria, they are ineligible to participate:
- the school authority refuses to participate;
- a specialist and/or independent or private school;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Pakistan · 1 center
- Public school for boys 1 — Rawalpindi
Identifiers
NCT: NCT06442007 · Mindset-PK