이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

파키스탄의 청소년의 내부화 증상을 내재화하기위한 학교 기반 스텝 케어 프로그램의 타당성 평가 : 파일럿 순차적 다중 과제 클러스터 무작위 시험 (Smart-Step) (SMART-STEP)

2026년 9월 15일 업데이트: Global Institute of Human Development

파키스탄의 청소년의 내재화 증상을위한 학교 기반 계단식 치료 프로그램의 타당성 평가

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

137

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

13년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

다른 이름들:
  • CBT 기반 가이드 자조 응용 프로그램
활성 비교기: 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.

다른 이름들:
  • CBT 기반 가이드 자조 응용 프로그램

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Patient Health Questionnaire (PHQ-9) for adolescents
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Pediatric Symptoms Checklist (PSC)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Syed Usman Hamdani, PhD MBBS, Global Institute of Human Development

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 3월 28일

기본 완료 (실제)

2025년 6월 30일

연구 완료 (실제)

2025년 8월 31일

연구 등록 날짜

최초 제출

2025년 3월 5일

QC 기준을 충족하는 최초 제출

2025년 3월 11일

처음 게시됨 (실제)

2025년 3월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 15일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • GIHD/Trials/2024/01
  • R01MH131025-03 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다