Clinical trial NCT06442007: Universally Delivered Interventions for Young People
Official title: A 3-arm Multi-Center Exploratory Trial of Universally Delivered Interventions for Prevention of Anxiety and Depression in Young People in Pakistan
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Distress, Emotional
Keywords: adolescents
anxiety
depression
single session interventions
growth mindset
Pakistan
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: Fatima Jinnah Women University
First posted: 2024-06-04
Enrollment: 564
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three arm study. Schools would be the unit of cluster.
Primary purpose: PREVENTION

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.

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:

1. the school authority agrees to participate;
2. the schools shall be non-specialist public schools;
3. school contains at least 80 students; Exclusion criteria

If the school meet the following exclusion criteria, they are ineligible to participate:

1. the school authority refuses to participate;
2. a specialist and/or independent or private school;

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Total recruitment period is 3 months. Change in numbers will be recorded from first month of recruitment to 3rd month of recruitment
measure: Feasibility of intervention
timeFrame: Retention of participants in the Intervention at the completion of one month intervention period.
measure: Depression
timeFrame: Change in scores from baseline to 3-month follow up.
Secondary outcomes:
measure: The Revised Child Anxiety and Depression Scale
timeFrame: Change in scores from baseline to 3-month follow up
measure: Growth Mindset scale
timeFrame: Change in scores from baseline to 3-month follow up
measure: Beck's hopelessness Scale short version
timeFrame: Change in scores from baseline to 3-month follow up
measure: EuroQol Quality of Life scale
timeFrame: Change in scores from baseline to 3-month follow up
measure: Program Feedback Scale
timeFrame: Total acceptability score at completion of one month intervention period.
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Public school for boys 1
state: Punjab
Study officials:
References: