Universally Delivered Interventions for Young People

NCT06442007 | Not Yet Recruiting DMC

• 1 other identifier: Mindset-PK
• Study Type: interventional
• Target: 564
• Locations: 1 country
• Sites: 1

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.

Conditions

Distress, Emotional

Keywords

adolescents; anxiety; depression; single session interventions; growth mindset; Pakistan

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• The Revised Child Anxiety and Depression Scale

  Change in scores from baseline to 3-month follow up

• Growth Mindset scale

  Change in scores from baseline to 3-month follow up

• Beck's hopelessness Scale short version

  Change in scores from baseline to 3-month follow up

• EuroQol Quality of Life scale

  Change in scores from baseline to 3-month follow up

• Program Feedback Scale

  Total acceptability score at completion of one month intervention period.

Study Arms (3)

Behavioral Activation - single session intervention (BA-SSI)

EXPERIMENTAL

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.

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

4-session Mindset intervention

ACTIVE COMPARATOR

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

Waiting list control group

NO INTERVENTION

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

Interventions

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

Single session intervention

Behavioral Activation - single session intervention (BA-SSI)

4-session Mindset intervention BEHAVIORAL

This is comprised of 4 sessions.

4-session Mindset intervention

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 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;
• the school authority refuses to participate;
• a specialist and/or independent or private school;

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• Fatima Jinnah Women University: collaborator

Study Sites (1)

Public school for boys 1

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Tayyeba Kiran, PhD

CONTACT

0923328262142; tayyebakiran@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three arm study. Schools would be the unit of cluster.

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 4, 2024
• Study Start: May 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)