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Effectiveness and Implementation of a School-based Mental Well-being Intervention Among Adolescents of Bharatpur, Nepal (CROSSMIND_NP)

3 сентября 2026 г. обновлено: University of Aarhus

Adaptation, Effectiveness and Implementation of a School-Based Mental Well-Being Intervention (CROSS-MIND) Among Adolescents of Bharatpur Metropolitan, Chitwan, Nepal

The goal of this study is to evaluate the effectiveness and assess the implementation of CROSS-MIND, a school-based mental well-being intervention for adolescents in Nepal. The study uses a Hybrid Type 1 mixed-methods design. The main questions it aims to answer are:

Does CROSS-MIND improve students' mental well-being, self-esteem, and behavioural and emotional outcomes compared with usual school activities? Is CROSS-MIND acceptable, feasible, appropriate, and delivered with adequate fidelity, and what barriers and facilitators influence its delivery by teachers?

For the effectiveness evaluation, classes of grades 6 to 10 in five schools in Bharatpur Metropolitan City will be randomly assigned to receive either the CROSS-MIND intervention or usual school activities. Students will complete questionnaires before and after the intervention. Students in intervention classes will participate in eight weekly storytelling and reflection sessions of approximately 90 minutes, delivered by trained teachers. Qualitative interviews and focus group discussions will also be conducted with selected students, teachers, school principals, and psychologists to explore experiences of the intervention and factors influencing its implementation.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

Adolescent mental well-being is an important public health concern, and schools provide an appropriate setting for universal mental health promotion interventions. This study aims to evaluate CROSS-MIND, a school-based mental well-being intervention designed for adolescents in Nepal.

The effectiveness component is a pilot cluster randomized controlled trial in which classes from five schools in Bharatpur Metropolitan City will be randomly assigned to either the CROSS-MIND intervention or usual school activities. Students in Grades 6-10 will participate in baseline and endline assessments. The primary outcome is mental well-being measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Secondary outcomes include self-esteem, behavioural and emotional problems, depressive symptoms, and anxiety symptoms, measured using the Rosenberg Self-Esteem Scale (RSES), Strengths and Difficulties Questionnaire (SDQ), PHQ-9-A, and GAD-7-A, respectively.

CROSS-MIND consists of eight weekly storytelling circle sessions of approximately 90 minutes, delivered by trained teachers within the school setting. The intervention uses structured storytelling, reflection, creative expression, and group discussion to support positive self-identity, emotional awareness, social connectedness, coping skills, and psychological well-being.

The study also includes an implementation component. Implementation will be assessed in terms of acceptability, feasibility, appropriateness, and fidelity. Qualitative interviews and focus group discussions will explore participants' experiences and identify barriers and facilitators to implementation.

Тип исследования

Интервенционный

Регистрация (Оцененный)

1060

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Liladhar Dhakal, PhD Student
  • Номер телефона: 977 9851192356
  • Электронная почта: liladhar.dhakal@ph.au.dk

Учебное резервное копирование контактов

  • Имя: Per Kallestrup, PhD
  • Номер телефона: +45 22428484
  • Электронная почта: per.kallestrup@ph.au.dk

Места учебы

  • Непал
    • Bagmati
      • Bharatpur, Bagmati, Непал
        • Schools

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок
  • Взрослый

Принимает здоровых добровольцев

Да

Описание

Inclusion criteria:

  • Students enrolled in grades 6-10 in the participating schools
  • Students whose parent or guardian provides written informed consent
  • Students who provides written informed assent

Exclusion Criteria:

- Students who are not expected to participate in regular classroom activities

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: CROSS-MIND Intervention

CROSS-MIND is an eight-week, teacher-facilitated school-based mental well-being intervention. Students participate in one approximately 90-minute storytelling circle session each week. Sessions use structured storytelling, reflection, creative expression, group discussion, and peer-reflection activities.

Major intervention areas include establishing a safe and supportive group environment; identifying and exploring common adolescent challenges; using narrative externalisation to separate problems from personal identity; reflecting on life experiences, strengths, and aspirations through Life River activities; identifying coping skills and supportive relationships; and consolidating learning through reflective writing, poetry or letter-writing and a closing celebration.
Поведенческий: CROSS-MIND

CROSS-MIND is an eight-week, teacher-facilitated school-based mental well-being intervention. Students participate in one approximately 90-minute storytelling circle session each week. Sessions use structured storytelling, reflection, creative expression, group discussion, and peer-reflection activities.

Major intervention areas include establishing a safe and supportive group environment; identifying and exploring common adolescent challenges; using narrative externalisation to separate problems from personal identity; reflecting on life experiences, strengths, and aspirations through Life River activities; identifying coping skills and supportive relationships; and consolidating learning through reflective writing, poetry or letter-writing and a closing celebration.
Без вмешательства: Regular School Activities
Students assigned to the control group will continue with their usual school activities and will not receive the CROSS-MIND intervention during the study period.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change from baseline in the mean mental well-being score after the intervention
Временное ограничение: Baseline before intervention and endline within a week of intervention completion
The primary outcome, mental well-being, will be measured using Warwick-Edinburgh mental well-being scale. It uses a five-point Likert response scale and has a total score range of 14-70, with higher scores indicating better mental well-being.
Baseline before intervention and endline within a week of intervention completion

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change from baseline in the mean Self-Esteem score after the intervention
Временное ограничение: Baseline before intervention and endline within a week of intervention completion
Self-esteem will be measured using the Rosenberg Self-Esteem Scale. It uses a four-point Likert response scale and has a total score range of 0-30, with higher scores indicating better outcome i.e. higher self-esteem.
Baseline before intervention and endline within a week of intervention completion
Change from baseline in the mean depressive symptoms score after the intervention
Временное ограничение: Baseline before intervention and endline within a week of intervention completion
Depressive symptoms will be measured using the Patient Health Questionnaire -adolescent version. It uses a four-point response scale and has a total score range of 0-27, with higher scores indicating worse outcome i.e., depressive symptoms.
Baseline before intervention and endline within a week of intervention completion
Change from baseline in the mean anxiety symptoms score after the intervention
Временное ограничение: Baseline before intervention and endline within a week of intervention completion
Anxiety symptoms will be measured using the Generalized Anxiety Disorder-7 adolescent version. It uses a four-point Likert response scale and has a total score range of 0-21, with higher scores indicating worse outcome i.e., higher anxiety symptoms.
Baseline before intervention and endline within a week of intervention completion
Change from baseline in the mean difficulty score after the intervention
Временное ограничение: Baseline before intervention and endline within a week of intervention completion
Total difficulty will be measured using the Strength and Difficulty Questionnaire adolescent self-administration version. It uses a three-point response scale and has a total score range of 0-40, with higher scores indicating worse outcomes, i.e., greater difficulty.
Baseline before intervention and endline within a week of intervention completion
Acceptability of CROSS-MIND
Временное ограничение: At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention
Acceptability will be assessed using the 4-item Acceptability of Intervention Measure. Each item is rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree), with total scores ranging from 4 to 20; higher scores indicate greater acceptability. The measure will be completed by teachers who delivered CROSS-MIND sessions and students who participated in the sessions.
At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention
Feasibility of delivering CROSS-MIND from the perspective of intervention-delivering teachers
Временное ограничение: At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention
Feasibility will be assessed using the 4-item Feasibility of Intervention Measure (FIM). Each item is rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree), with total scores ranging from 4 to 20; higher scores indicate greater perceived feasibility. The measure will be completed by teachers who delivered CROSS-MIND sessions.
At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention
Perceived appropriateness of CROSS-MIND
Временное ограничение: At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention
Appropriateness will be assessed using the 4-item Intervention Appropriateness Measure (IAM). Each item is rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree), with total scores ranging from 4 to 20; higher scores indicate greater perceived appropriateness. The measure will be completed by teachers who delivered CROSS-MIND sessions and students who participates in the sessions.
At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention
Fidelity of CROSS-MIND intervention delivery
Временное ограничение: Throughout the 8-week intervention period
Fidelity will be assessed throughout the intervention using session delivery records and monitoring of intervention sessions. Assessment will include adherence to the planned intervention components, intervention dose (sessions delivered) and quality of delivery.
Throughout the 8-week intervention period

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Aarhus

Следователи

  • Учебный стул: Per Kallestrup, PhD, University of Aarhus
  • Главный следователь: Liladhar Dhakal, University of Aarhus

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 сентября 2026 г.

Первичное завершение (Оцененный)

30 ноября 2026 г.

Завершение исследования (Оцененный)

30 ноября 2026 г.

Даты регистрации исследования

Первый отправленный

26 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

3 сентября 2026 г.

Первый опубликованный (Действительный)

10 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

10 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

3 сентября 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 330_2026_CROSS-MIND_Nepal_AU

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

De-identified individual participant data underlying the reported study outcomes, including baseline and endline demographic characteristics, intervention group allocation, primary and secondary outcome measures, and implementation outcome measures, will be shared.

Сроки обмена IPD

Beginning 3 months after publication with no end date

Критерии совместного доступа к IPD

De-identified IPD and supporting information will be made available to qualified researchers upon reasonable request and subject to approval by the principal investigator and relevant institutional/ethical requirements. Access will be limited to data necessary for the approved research purpose. Requests will be submitted to the principal investigator, and data will be provided through a secure data-sharing mechanism following appropriate data-use and confidentiality agreements.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • МКФ
  • АНАЛИТИЧЕСКИЙ_КОД

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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