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Valutazione della fattibilità di un programma di assistenza a gradini a scuola per interiorizzare i sintomi negli adolescenti in Pakistan: una prova randomizzata randomizzata del cluster di assegnazione multipla sequenziale pilota (Smart-Step) (SMART-STEP)

15 settembre 2026 aggiornato da: Global Institute of Human Development

Valutazione della fattibilità di un programma di assistenza a gradini a scuola per interiorizzare i sintomi negli adolescenti 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

137

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 46000
        • Global Institute of Human Development

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 13 anni a 15 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

1. 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:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention arm - Enhanced School Mental Health Program (eSMHP) Plus

The first-stage intervention, eSMHP Plus, is delivered by teachers and non-specialists in classrooms. eSMHP enhances mental health literacy, training providers in early identification, counseling, life skills, positive discipline, parental engagement, referrals, and teacher well-being. Teachers follow a lesson plan, supported by non-specialists through biweekly school visits. Non-specialists co-deliver activities and supervise teachers to address challenges and promote well-being. At six weeks, adolescents scoring ≥28 on PSC are re-randomized to continue eSMHP Plus or receive a step-up, CBT-based guided self-help app for two months. The app, accessible via tablet/mobile, is based on empirically supported strategies.

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.

Altri nomi:
  • Applicazione di auto-aiuto guidata basata sulla CBT
Comparatore attivo: Enhanced Treatment-as-usual

The first-stage intervention in the control arm, eSMHP, is delivered by teachers only. Teachers in ETAU complete online training (www.learnwithshine.org) to enhance mental health literacy, learning to identify socioemotional issues and provide basic psychosocial support through counseling skills, life skills, positive discipline, parental engagement, and referrals. A dedicated module promotes teacher well-being. At six weeks, adolescents scoring ≥28 on PSC are re-randomized to continue eSMHP or receive a step-up, CBT-based guided self-help app for two months. The app, accessible via tablet/mobile, is based on empirically supported strategies and offers comprehensive features for adolescents.

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.

Altri nomi:
  • Applicazione di auto-aiuto guidata basata sulla CBT

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient Health Questionnaire (PHQ-9) for adolescents
Lasso di tempo: 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).

Enrollment, and 6 weeks and 3-months from baseline

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pediatric Symptoms Checklist (PSC)
Lasso di tempo: 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.

Enrollment, and 6 weeks and 3-months from baseline
Revised Children's Anxiety and Depression Scale (RCADS)
Lasso di tempo: 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.

From enrollment to the end of treatment at 3-months
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom Measure
Lasso di tempo: 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.

From enrollment to the end of treatment at 3-months
Checklist of Somatic Symptoms of Distress
Lasso di tempo: 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.

From enrollment to the end of treatment at 3-months
Experience of bullying
Lasso di tempo: 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.

From enrollment to the end of treatment at 3-months
School climate
Lasso di tempo: 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.

From enrollment to the end of treatment at 3-months
Annual academic performance and classroom attendance questionnaire
Lasso di tempo: 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.

From enrollment to the end of treatment at 3-months
Wellbeing
Lasso di tempo: 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.

From enrollment to the end of treatment at 3-months
Teachers' wellness
Lasso di tempo: 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

From enrollment to the end of treatment at 3-months
Teachers' sense of self-efficacy
Lasso di tempo: 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'.

From enrollment to the end of treatment at 3-months
Psychosocial Profile of the School
Lasso di tempo: 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.

From enrollment to the end of treatment at 3-months
Caregivers' Wellbeing
Lasso di tempo: 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

From enrollment to the end of treatment at 3-months
Alabama Parenting Questionnaire (APQ)
Lasso di tempo: 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.

From enrollment to the end of treatment at 3-months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Syed Usman Hamdani, PhD MBBS, Global Institute of Human Development

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 marzo 2025

Completamento primario (Effettivo)

30 giugno 2025

Completamento dello studio (Effettivo)

31 agosto 2025

Date di iscrizione allo studio

Primo inviato

5 marzo 2025

Primo inviato che soddisfa i criteri di controllo qualità

11 marzo 2025

Primo Inserito (Effettivo)

18 marzo 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • GIHD/Trials/2024/01
  • R01MH131025-03 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

The availability of individual participant data (IPD) has not been determined at this time.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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