Mental HealthCROSSMIND_NPNCT07812168
Effectiveness and Implementation of a School-based Mental Well-being Intervention Among Adolescents of Bharatpur, Nepal
A study testing CROSS-MIND in people with Mental Health, run by University of Aarhus at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- CROSS-MIND
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,060 participants
- Where
- 1 siteNepal
- Study dates
- 1 Sep 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Students who are not expected to participate in regular classroom activities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health
- Being tested
- CROSS-MIND
- Keywords
- mental well-being, adolescent, School based intervention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CROSS-MINDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline before intervention and endline within a week of intervention completion
Change from baseline in the mean depressive symptoms score after the intervention
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.
Measured: Baseline before intervention and endline within a week of intervention completion
Change from baseline in the mean anxiety symptoms score after the intervention
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.
Measured: Baseline before intervention and endline within a week of intervention completion
Change from baseline in the mean difficulty score after the intervention
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.
Measured: Baseline before intervention and endline within a week of intervention completion
Acceptability of CROSS-MIND
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Throughout the 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per Kallestrup, PhD, Study chair, University of AarhusLiladhar Dhakal, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812168
- Sponsor's protocol ID
- 330_2026_CROSS-MIND_Nepal_AU
- Acronym
- CROSSMIND_NP
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation, Effectiveness and Implementation of a School-Based Mental Well-Being Intervention (CROSS-MIND) Among Adolescents of Bharatpur Metropolitan, Chitwan, Nepal
- ClinicalTrials.gov ID
- NCT07812168
- Acronym / sponsor ID
- CROSSMIND_NP / 330_2026_CROSS-MIND_Nepal_AU
- Conditions
- Mental Health
- Keywords
- mental well-being, adolescent, School based intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,060 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CROSS-MIND Intervention | Experimental | Behavioral: CROSS-MINDCROSS-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. |
| 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. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Students who are not expected to participate in regular classroom activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CROSS-MINDCROSS-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. | Behavioural | CROSS-MIND Intervention |
Primary outcome
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.
8 secondary outcomes
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
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
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
Change from baseline in the mean difficulty score after the intervention
Time frame: 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
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
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
Fidelity of CROSS-MIND intervention delivery
Time frame: Throughout the 8-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Per Kallestrup, PhD study chair
University of Aarhus
Liladhar Dhakal principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CROSS-MIND in people with Mental Health, run by University of Aarhus at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liladhar Dhakal, PhD Student (977 9851192356, liladhar.dhakal@ph.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.