Universally Delivered Interventions for Young People

Distress, Emotional Clinical Trial

— Mindset-PK  

Official title:

A 3-arm Multi-Center Exploratory Trial of Universally Delivered Interventions for Prevention of Anxiety and Depression in Young People in Pakistan

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442007
• Other study ID #: Mindset-PK
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: May 2024
• Source: Pakistan Institute of Living and Learning
• Contact: Tayyeba Kiran, PhD
• Phone: 0923328262142
• Email: tayyebakiran[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 564
• Est. completion date: March 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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;

Related Conditions & MeSH terms

• Distress, Emotional

Intervention

Behavioral:
• Behavioral Activation - single session intervention (BA-SSI)
Single session intervention
• 4-session Mindset intervention
This is comprised of 4 sessions.

Locations

Country	Name	City	State
Pakistan	Public school for boys 1	Rawalpindi	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning	Fatima Jinnah Women University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Secondary	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").	Change in scores from baseline to 3-month follow up
Secondary	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 ?xed mindsets, and lower scores, stronger growth mindsets.	Change in scores from baseline to 3-month follow up
Secondary	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
Secondary	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
Secondary	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.