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

3. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

1060

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Bagmati
      • Bharatpur, Bagmati, Nepal
        • Schools

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

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.

Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in the mean mental well-being score after the intervention
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in the mean Self-Esteem score after the intervention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Per Kallestrup, PhD, University of Aarhus
  • Hovedetterforsker: Liladhar Dhakal, University of Aarhus

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

30. november 2026

Studiet fullført (Antatt)

30. november 2026

Datoer for studieregistrering

Først innsendt

26. august 2026

Først innsendt som oppfylte QC-kriteriene

3. september 2026

Først lagt ut (Faktiske)

10. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 330_2026_CROSS-MIND_Nepal_AU

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Beginning 3 months after publication with no end date

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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