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临床试验/NCT07812168
NCT07812168尚未招募不适用

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

University of Aarhus1 个研究点 分布在 1 个国家目标入组 1,060 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,060
试验地点
1
主要终点
Change from baseline in the mean mental well-being score after the intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
11 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

CROSS-MIND Intervention

Experimental

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.

干预措施: CROSS-MIND (Behavioral)

Regular School Activities

No Intervention

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.

结局指标

主要结局

Change from baseline in the mean mental well-being score after the intervention

时间窗: 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.

次要结局

  • Change from baseline in the mean Self-Esteem score after the intervention(Baseline before intervention and endline within a week of intervention completion)
  • Change from baseline in the mean depressive symptoms score after the intervention(Baseline before intervention and endline within a week of intervention completion)
  • Change from baseline in the mean anxiety symptoms score after the intervention(Baseline before intervention and endline within a week of intervention completion)
  • Change from baseline in the mean difficulty score after the intervention(Baseline before intervention and endline within a week of intervention completion)
  • Acceptability of CROSS-MIND(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(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(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(Throughout the 8-week intervention period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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