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NCT Number: NCT07812168

Effectiveness and Implementation of a School-based Mental Well-being Intervention Among Adolescents of Bharatpur, 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.

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Key information

Conditions

Mental Health Behavior Personal Satisfaction Psychological Well-Being

Age range

11 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schools

Bharatpur, Bagmati, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

CROSS-MIND

Behavioral

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Change from baseline in the mean Self-Esteem score after the intervention

    Time frame: 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.

  2. Change from baseline in the mean depressive symptoms score after the intervention

    Time frame: 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.

  3. Change from baseline in the mean anxiety symptoms score after the intervention

    Time frame: 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.

  4. Change from baseline in the mean difficulty score after the intervention

    Time frame: 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.

  5. Acceptability of CROSS-MIND

    Time frame: 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.

  6. Feasibility of delivering CROSS-MIND from the perspective of intervention-delivering teachers

    Time frame: 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.

  7. Perceived appropriateness of CROSS-MIND

    Time frame: 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.

  8. Fidelity of CROSS-MIND intervention delivery

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: CROSSMIND_NP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

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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