- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Liladhar Dhakal, PhD Student
- 전화번호: 977 9851192356
- 이메일: liladhar.dhakal@ph.au.dk
연구 연락처 백업
- 이름: Per Kallestrup, PhD
- 전화번호: +45 22428484
- 이메일: per.kallestrup@ph.au.dk
연구 장소
-
-
Bagmati
-
Bharatpur, Bagmati, 네팔
- Schools
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
간섭 없음: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in the mean mental well-being score after the intervention
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in the mean Self-Esteem score after the intervention
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 의자: Per Kallestrup, PhD, University of Aarhus
- 수석 연구원: Liladhar Dhakal, University of Aarhus
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .