Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442007
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-17
Brief Title:
Universally Delivered Interventions for Young People
Sponsor:
Pakistan Institute of Living and Learning
Organization:
Pakistan Institute of Living and Learning
Study Overview
Official Title:
A 3-arm Multi-Center Exploratory Trial of Universally Delivered Interventions for Prevention of Anxiety and Depression in Young People in Pakistan
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mindset-PK
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None