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

NCT07812168 | Not Yet Recruiting

• 1 other identifier: 330_2026_CROSS-MIND_Nepal_AU
• Study Type: interventional
• Target: 1,060
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health

Keywords

mental well-being; adolescent; School based intervention

Outcome Measures

Primary Outcomes (1)

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

  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

Secondary Outcomes (8)

• 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

Study Arms (2)

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.

Behavioral: CROSS-MIND

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.

Interventions

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.

CROSS-MIND Intervention

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Schools

Bharatpur, Bagmati, Nepal

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Per Kallestrup, PhD

  University of Aarhus

  STUDY CHAIR

• Liladhar Dhakal

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liladhar Dhakal, PhD Student

CONTACT

977 9851192356; liladhar.dhakal@ph.au.dk

Per Kallestrup, PhD

CONTACT

+45 22428484; per.kallestrup@ph.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm, parallel-group cluster randomized controlled trial in which classes of grades 6 to 10 within five participating schools will be randomly assigned to either the CROSS-MIND intervention or usual school activities. Classes will serve as the unit of randomization, while individual students will be assessed at baseline and endline.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 10, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months after publication with no end date
• Access Criteria: 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.

Locations

NE (1)