Universally Delivered Interventions for Young People (Mindset-PK)

Pakistan Institute of Living and Learning

Status: Not yet enrolling

Conditions: Distress, Emotional

Treatments: Behavioral: 4-session Mindset intervention; Behavioral: Behavioral Activation - single session intervention (BA-SSI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06442007

Mindset-PK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 564 estimated patients

Sex: All

Ages: 12 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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564 participants in 3 patient groups

Behavioral Activation - single session intervention (BA-SSI)

Experimental group

Description:

This is comprised of 5 five components: 1. Discussion on the rationale of the behavioral activation 2. Awareness raising about distress, including how behavior shapes feelings and thoughts; 3. a life values assessment 4. the creation of an activity action plan 5. 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.

Treatment:

Behavioral: Behavioral Activation - single session intervention (BA-SSI)

4-session Mindset intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: 4-session Mindset intervention

Waiting list control group

No Intervention group

Description:

At end of the study, this group will be offered to choose one intervention from two active interventions mentioned above.