Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06442007

Universally Delivered Interventions for Young People

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Distress, Emotional Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Behavioral Activation - single session intervention (BA-SSI)

Behavioral

Single session intervention

4-session Mindset intervention

Behavioral

This is comprised of 4 sessions.

Primary outcomes

  1. 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

    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

  2. Feasibility of intervention

    Time frame: Retention of participants in the Intervention at the completion of one month intervention period.

    Session attendance for each participant in active study arms for each session will be recorded and maintained in participant intervention log.

  3. Depression

    Time frame: Change in scores from baseline to 3-month follow up.

    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

Secondary outcomes

  1. The Revised Child Anxiety and Depression Scale

    Time frame: Change in scores from baseline to 3-month follow up

    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").

  2. Growth Mindset scale

    Time frame: Change in scores from baseline to 3-month follow up

    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.

  3. Beck's hopelessness Scale short version

    Time frame: Change in scores from baseline to 3-month follow up

    A 4-item short version of the Hopelessness Scale includes all the affective, cognitive and motivational components of hopelessness.

  4. EuroQol Quality of Life scale

    Time frame: Change in scores from baseline to 3-month follow up

    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.

  5. Program Feedback Scale

    Time frame: Total acceptability score at completion of one month intervention period.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tayyeba Kiran, PhD

CONTACT

[email protected]

0923328262142

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Collaborators

  • Fatima Jinnah Women University

Registry information

Official study title

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

Acronym: Mindset-PK

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.