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

September 3, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1060

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Nepal
    • Bagmati
      • Bharatpur, Bagmati, Nepal
        • Schools

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline before intervention and endline within a week of intervention completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline before intervention and endline within a week of intervention completion
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.
Baseline before intervention and endline within a week of intervention completion
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.
Baseline before intervention and endline within a week of intervention completion
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.
Baseline before intervention and endline within a week of intervention completion
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.
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
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.
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
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.
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
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.
Throughout the 8-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Per Kallestrup, PhD, University of Aarhus
  • Principal Investigator: Liladhar Dhakal, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 330_2026_CROSS-MIND_Nepal_AU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 3 months after publication with no end date

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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