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NCT Number: NCT06881342

Evaluating the Feasibility of a School-based Stepped Care Program for Internalizing Symptoms in Adolescents in Pakistan

This study aims to explore effective ways to reduce depressive symptoms in adolescents through two school-based interventions. This study examines whether the Enhanced School Mental Health Program (eSMHP) Plus, delivered by teachers and non-specialists, can serve as a first-line intervention to reduce psychosocial distress-an intermediate outcome that must be addressed to lower the risk of depression (primary outcome) in adolescents. For those who do not respond to eSMHP Plus, the study investigates if a Cognitive Behavioural Therapy (CBT) based guided self-help app could be an effective step-up or second-level intervention. Researchers will assess the feasibility and acceptability of these approaches among 200 adolescents (aged 13-15) from 8 public schools in Rawalpindi, Pakistan. Findings will guide future large-scale studies and strategies for personalised mental health care for adolescents in low-resource settings.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

13 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Global Institute of Human Development

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

Background:

Internalizing symptoms among adolescents can have long-term devastating impacts on their lives unless they are identified and treated early and effectively. Both universal and indicated school-based interventions are recommended to address internalizing symptoms among adolescents. However, determining the optimal timing and dosage of these interventions remains a crucial question for effective adolescent mental healthcare. The investigators will conduct a pilot Sequential Multiple Assignment Randomized Controlled Trial (SMART) to explore the feasibility and acceptability of two evidence-informed intervention strategies (universal and indicated interventions) within the stepped care model, compare their timing and dosage, and determine in which sequence these interventions should be delivered to whom. This study aims to answer the question, "What works, for whom, under what conditions, and why, for internalizing symptoms in adolescents with a focus on depressive symptoms?"

Methods:

A 20-week single-blind pilot cluster SMART study will be conducted in 8 public schools in Rawalpindi, Pakistan, to assess the feasibility and acceptability of 2 intervention strategies (i.e., 1. teachers plus non-specialist delivered universal intervention called Enhanced School Mental Health Program [eSMHP] Plus and 2. Guided self-help application of Cognitive Behavioural Therapy-based indicated intervention to reduce depression (internalising symptoms) in adolescents. The study participants will be approximately 200 adolescents, aged 13-15 of both sexes, with psychosocial distress. Data on the feasibility and acceptability of the study design, views about augmented intervention options and procedures, and treatment response rates will be collected. Results from the pilot study will yield additional research questions and will improve our ability to successfully conduct the definitive SMART to inform personalised interventions for internalising symptoms in adolescents.

Discussion: The findings of the study will be used to inform the design of a subsequent fully powered, definitive SMART study in Pakistan.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adolescents aged 13-15 years, studying in grades 7 and 8 of participating schools, provide assent and parental consent for participation in the study and screen positive for psychosocial distress on youth reported PSC (total score ≥ 28).

Exclusion criteria

  • Adolescents who require immediate in-patient (medical and/or psychiatric) care
  • Adolescents with acute protection risks as assessed by a researcher applying the definitions in the WHO mhGAP intervention guide.

Treatment and study plan

Enhanced School Mental Health Program (eSMHP)

Behavioral

The first-stage intervention is eSMHP Plus in the intervention arm and eSMHP in the control arm. In the intervention arm, adolescents receive eSMHP Plus from teachers and non-specialists, while in the control arm, they receive eSMHP from teachers. eSMHP, based on developmental, behavioral, social, and cognitive theories, enhances teachers' mental health literacy, training them in early identification, basic counseling, life skills, positive discipline, parental engagement, referrals, and teacher well-being. The second-stage intervention is a CBT-based self-help app. At six weeks, adolescents scoring ≥28 on PSC in both arms (indicating psychosocial distress) are re-randomized to continue their initial treatment (eSMHP Plus or eSMHP) or receive a step-up, CBT-based guided self-help app for two months.

Other names: CBT-based Guided Self-Help Application

Primary outcomes

  1. Patient Health Questionnaire (PHQ-9) for adolescents

    Time frame: Enrollment, and 6 weeks and 3-months from baseline

    Patient Health Questionnaire (PHQ-9) for adolescents is a 9-item instrument (on a 4-point Likert scale; range 0-27) to measure depressive symptoms in the past 2 weeks (Richardson et al., 2010) and that is previously adapted, validated and shown high reliability in Pakistan (Cronbach α=0.83).

Secondary outcomes

  1. Pediatric Symptoms Checklist (PSC)

    Time frame: Enrollment, and 6 weeks and 3-months from baseline

    PSC will also serve as an intermediate tailoring variable. It is well-established 35-item scale. It consists of three subscales, internalizing, externalizing and attention problems. The Urdu version has been previously adapted and used in Pakistan, showing satisfactory reliability and validity.

  2. Revised Children's Anxiety and Depression Scale (RCADS)

    Time frame: From enrollment to the end of treatment at 3-months

    It is a 25-item instrument (on a 4-point Likert scale; range 0-100) to measure levels of anxiety and low mood. It has two subscales (anxiety & depression). It has been adapted and used successfully in Pakistan.

  3. Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom Measure

    Time frame: From enrollment to the end of treatment at 3-months

    It is a self-rated measure that assesses mental health domains that are important across psychiatric diagnoses. It is intended to help identify additional areas of inquiry that may have a significant impact on the child's treatment and prognosis. Each item on the measure is rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). A rating of mild (i.e., 2) or greater on any item within a domain (except for suicidal ideation and psychosis) will serve as a guide for additional inquiry and follow-up to determine if a more detailed assessment for that domain is necessary.

  4. Checklist of Somatic Symptoms of Distress

    Time frame: From enrollment to the end of treatment at 3-months

    It is a 10-item tool (on a 3-point Likert scale); 0-20 to measure somatic symptoms of distress. It has been previously adapted and used in Pakistan.

  5. Experience of bullying

    Time frame: From enrollment to the end of treatment at 3-months

    Experience of bullying in the past 30 days will be measured through the contextualised version of the Bullying Victimization Questionnaire. The total score can range from 0 to 12, with higher scores indicating higher levels of victimization by peers.

  6. School climate

    Time frame: From enrollment to the end of treatment at 3-months

    The change in school climate (students' relationship with teachers, belongingness with the schools and peers, students' commitment to the school tasks, and participation in school activities) will be measured using the adapted version of the Beyound Blue School Climate Questionnaire. The tool will be administered to both children and their caregivers. The questionnaire consists of 28 items. Each item is rated on a 3-point Likert scale (yes=1, No = 0, I can't say = no score). The total score of BBSCQ can range from 0 to 28, where higher scores indicate a more favourable view of the school climate.

  7. Annual academic performance and classroom attendance questionnaire

    Time frame: From enrollment to the end of treatment at 3-months

    A study-specific questionnaire will be developed to obtain records of attendance and academic grades from the school records at baseline and 3 months post-intervention delivery.

  8. Wellbeing

    Time frame: From enrollment to the end of treatment at 3-months

    Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWS): It is a 7-item scale and assesses the mental wellbeing by evaluating the functioning of thoughts and feelings in the past two weeks. Items are rated on Likert scale that ranges from "none of the time" to "all of the time". The total score is calculated by summing the responses on all the items.

  9. Teachers' wellness

    Time frame: From enrollment to the end of treatment at 3-months

    The Self Reporting Questionnaire (SRQ) is a 20-item self-report measure to detect non-specific psychological distress, developed by the WHO. Psychological distress is represented by subscales of physical symptoms and emotional symptoms. The SRQ items are scored 0 or 1. A score of 1 indicates the presence of symptoms of psychological distress

  10. Teachers' sense of self-efficacy

    Time frame: From enrollment to the end of treatment at 3-months

    The 12 items Teachers Sense of efficacy scale will be used to assess teacher's belief about his or her capabilities to enhance students' learning and to be able to support students who are difficult or unmotivated. The scale measures teacher's efficacy on three subscales namely, instructional strategies, student engagement, and classroom management. The items are rated on 5 points Likert scale ranging from (1) 'None at all' to (5) 'A great deal'.

  11. Psychosocial Profile of the School

    Time frame: From enrollment to the end of treatment at 3-months

    Each question is scored on a scale from 1 to 4, with 1 representing the lowest and 4 the highest rating of social and emotional support. To obtain an overall mean or average, the scores of all the answered questions are added and divided by the total number of questions answered. Higher scores indicate a better psychosocial environment at the school.

  12. Caregivers' Wellbeing

    Time frame: From enrollment to the end of treatment at 3-months

    The Self Reporting Questionnaire (SRQ) is a 20-item self-report measure to detect non-specific psychological distress, developed by the WHO. Psychological distress is represented by subscales of physical symptoms and emotional symptoms. The SRQ items are scored 0 or 1. A score of 1 indicates the presence of symptoms of psychological distress

  13. Alabama Parenting Questionnaire (APQ)

    Time frame: From enrollment to the end of treatment at 3-months

    The positive involvement subscale of the Alamaba Parenting Questionnaire (APQ) will be used to measure parenting practices. The subscale measures whether parents talk more friendly with children; help children in planning and conducting special activities; know what they are doing in their free time; play games with them; help them with their homework; get interested in their day-to-day plans and activities; and know about their friends. Items are rated on a five-point Likert scale (1 = never to 5 = almost always). The total score is calculated by summing all the items. The minimum score is 10, and the maximum score is 50. Higher scores indicate more positive outcomes.

Sponsors and collaborators

Lead sponsor

Global Institute of Human Development

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: SMART-STEP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Apr 22, 2025

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.

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