[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655360":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":48,"studyPopulation":40,"armGroups":49,"interventions":60,"overallOfficials":65,"centralContacts":72,"locations":81,"responsibleParty":94,"collaborators":40,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":40,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":121,"whyStopped":40,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"University of Aarhus","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,20,23,26,30,33,36],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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.",{"measure":27,"description":28,"timeFrame":29},"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.","At endline, within a week of the completion of the delivery of the last session, i.e., the 8th session of the intervention",{"measure":31,"description":32,"timeFrame":29},"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.",{"measure":34,"description":35,"timeFrame":29},"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.",{"measure":37,"description":38,"timeFrame":39},"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.","Throughout the 8-week intervention period",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":40,"timePerspective":40,"maskingInfo":46},"RANDOMIZED","PARALLEL","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.","PREVENTION",{"masking":47,"maskingDescription":40,"whoMasked":40},"NONE","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.\n\nThe 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.\n\nCROSS-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.\n\nThe 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.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"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.\n\nMajor 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.",[55],"Behavioral: CROSS-MIND",{"label":57,"type":58,"description":59,"interventionNames":40},"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.",[61],{"type":62,"name":63,"description":53,"armGroupLabels":64,"otherNames":40},"BEHAVIORAL","CROSS-MIND",[51],[66,69],{"name":67,"affiliation":5,"role":68},"Per Kallestrup, PhD","STUDY_CHAIR",{"name":70,"affiliation":5,"role":71},"Liladhar Dhakal","PRINCIPAL_INVESTIGATOR",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":40,"email":77},"Liladhar Dhakal, PhD Student","CONTACT","977 9851192356","liladhar.dhakal@ph.au.dk",{"name":67,"role":75,"phone":79,"phoneExt":40,"email":80},"+45 22428484","per.kallestrup@ph.au.dk",[82],{"facility":83,"status":40,"city":84,"state":85,"zip":40,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":40},"Schools","Bharatpur","Bagmati","Nepal","NP",{"type":89,"coordinates":90},"Point",[91,92],84.43647,27.68027,{"lat":92,"lon":91},{"type":95,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100655360","effectiveness-and-implementation-of-a-school-based-mental-well-being-intervention-among-adolescents-of-bharatpur-nepal-100655360",false,"NCT07812168","Effectiveness and Implementation of a School-based Mental Well-being Intervention Among Adolescents of Bharatpur, Nepal","Adaptation, Effectiveness and Implementation of a School-Based Mental Well-Being Intervention (CROSS-MIND) Among Adolescents of Bharatpur Metropolitan, Chitwan, Nepal","CROSSMIND_NP","Inclusion criteria:\n\n* Students enrolled in grades 6-10 in the participating schools\n* Students whose parent or guardian provides written informed consent\n* Students who provides written informed assent\n\nExclusion Criteria:\n\n\\- Students who are not expected to participate in regular classroom activities",true,"ALL","11 Years","19 Years",{"count":109,"type":110},1060,"ESTIMATED","INTERVENTIONAL",[113],"NA","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:\n\nDoes 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?\n\nFor 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.",[116],"Mental Health",[118,119,120],"mental well-being","adolescent","School based intervention","NOT_YET_RECRUITING","2026-09-03",{"date":124,"type":125},"2026-09-10","ACTUAL",{"date":127,"type":110},"2026-09-01",{"date":129,"type":110},"2026-11-30",{"name":5,"class":6},1]