- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07812168
Effectiveness and Implementation of a School-based Mental Well-being Intervention Among Adolescents of Bharatpur, Nepal (CROSSMIND_NP)
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Liladhar Dhakal, PhD Student
- Telefonní číslo: 977 9851192356
- E-mail: liladhar.dhakal@ph.au.dk
Studijní záloha kontaktů
- Jméno: Per Kallestrup, PhD
- Telefonní číslo: +45 22428484
- E-mail: per.kallestrup@ph.au.dk
Studijní místa
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Bagmati
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Bharatpur, Bagmati, Nepál
- Schools
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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. |
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Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change from baseline in the mean mental well-being score after the intervention
Časové okno: Baseline before intervention and endline within a week of intervention completion
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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.
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Baseline before intervention and endline within a week of intervention completion
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from baseline in the mean Self-Esteem score after the intervention
Časové okno: Baseline before intervention and endline within a week of intervention completion
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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.
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Baseline before intervention and endline within a week of intervention completion
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Change from baseline in the mean depressive symptoms score after the intervention
Časové okno: Baseline before intervention and endline within a week of intervention completion
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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.
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Baseline before intervention and endline within a week of intervention completion
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Change from baseline in the mean anxiety symptoms score after the intervention
Časové okno: Baseline before intervention and endline within a week of intervention completion
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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.
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Baseline before intervention and endline within a week of intervention completion
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Change from baseline in the mean difficulty score after the intervention
Časové okno: Baseline before intervention and endline within a week of intervention completion
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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.
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Baseline before intervention and endline within a week of intervention completion
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Acceptability of CROSS-MIND
Časové okno: At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention
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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.
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At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention
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Feasibility of delivering CROSS-MIND from the perspective of intervention-delivering teachers
Časové okno: At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention
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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.
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At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention
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Perceived appropriateness of CROSS-MIND
Časové okno: At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention
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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.
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At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention
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Fidelity of CROSS-MIND intervention delivery
Časové okno: Throughout the 8-week intervention period
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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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Throughout the 8-week intervention period
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Per Kallestrup, PhD, University of Aarhus
- Vrchní vyšetřovatel: Liladhar Dhakal, University of Aarhus
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 330_2026_CROSS-MIND_Nepal_AU
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
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