Universally Delivered Interventions for Young People (Mindset-PK)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Distress, Emotional
• Intervention / Treatment: Behavioral: Behavioral Activation - single session intervention (BA-SSI); Behavioral: 4-session Mindset intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 564
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tayyeba Kiran, PhD; Phone Number: 0923328262142; Email: tayyebakiran@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan
      • Public school for boys 1
      • Contact: Tayyeba Kiran, PhD; Phone Number: 0923328262142; Email: tayyebakiran@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Activation - single session intervention (BA-SSI); This is comprised of 5 five components: Discussion on the rationale of the behavioral activation; Awareness raising about distress, including how behavior shapes feelings and thoughts;; a life values assessment; the creation of an activity action plan; an exercise in which youths write about benefits that might result from engaging in each activity, an obstacle that might keep them from doing the activities and a strategy for overcoming the identified obstacles.	Behavioral: Behavioral Activation - single session intervention (BA-SSI); Single session intervention
Active Comparator: 4-session Mindset intervention; This is comprised of a growth mindset module (2 sessions), a gratitude module (1 session) and a value affirmations module (1 session). Sessions are delivered weekly (over 4 weeks) and each session lasts for an hour. Reading and writing activities and group discussions are included in each session. Participants are supposed to complete homework exercises are assigned between sessions.	Behavioral: 4-session Mindset intervention; This is comprised of 4 sessions.
No Intervention: Waiting list control group; At end of the study, this group will be offered to choose one intervention from two active interventions mentioned above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 fixed mindsets, and lower scores, stronger growth mindsets.	Change in scores from baseline to 3-month follow up
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
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
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.

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning
• Collaborators: Fatima Jinnah Women University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: depression; anxiety; adolescents; Pakistan; growth mindset; single session interventions
• Other Study ID Numbers: Mindset-PK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is the feasibility study and interventions will continue to refine and adapt. The IP is owned by the Pakistan Institute of Living and Learning

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No