- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07660874
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
The Development, Feasibility, and Acceptability of a Classroom-based Psychoeducational Programme About Psychosis for Adolescents.
This study is a mixed-methods feasibility trial designed to examine whether a universal classroom-based psychoeducational programme which covers unusual sensory experiences, psychosis, mental health stigma, and coping strategies can be delivered in secondary schools in Northern Ireland.
The study aims to determine whether the programme is feasible to deliver, whether students find it acceptable, and whether it is possible to collect questionnaire and reflection data at multiple time points.
Students will attend four classroom sessions delivered by the researcher as part of timetabled enrichment lessons. They will complete questionnaires before the programme, after it ends, and one month later. Brief reflections will also be completed after each session.
A small number of students may take part in an interview to explore their experiences of the programme. As a feasibility study, this trial does not assess intervention effectiveness but will inform the design of a future full-scale trial.
연구 개요
상세 설명
This is a mixed-methods feasibility study to evaluate the delivery, feasibility and acceptability of a universal psychoeducational programme. The intervention aims to build students' mental-health literacy and confidence in recognising and responding to distress. The programme is educational in focus; it is not designed to diagnose, treat symptoms, or identify individuals at clinical risk.
The trial uses a non-randomised parallel-group design in which participating secondary schools are allocated to either the intervention arm or a teaching-as-usual control arm. The intervention comprises four structured classroom sessions delivered within the normal school timetable. Session content includes: (1) understanding mental health and the stress response; (2) understanding unusual sensory experiences and psychosis; (3) understanding stigma and media influences; and (4) understanding thoughts and feelings using cognitive behavioural therapy-informed coping strategies. Sessions use multimedia materials, group discussion, and workbook activities. All content was co-designed with individuals with lived experience of psychosis, mental health professionals, and teachers. Students in the control arm will continue with teaching-as-usual during data collection and will be offered the intervention after the study follow-up period (waitlist).
Quantitive data will be collected at multiple timepoints to assess feasibility including recruitment, retention, data completeness, adherence to planned session components. Students will complete baseline, post intervention and one month follow up questionnaires, as well as brief surveys and reflections after each session to capture engagement and acceptability.
Pre-post changes in key outcomes will be explored descriptively using repeated measures approaches to examine patterns of change and to estimate variance for planning a future definitive trial, where data completeness permits.
Psychotic-like experiences, emotional and behavioural functioning, and help-seeking intentions will be assessed using validated self-report tools. These include the Prodromal Questionnaire-16 (PQ-16), the Strengths and Difficulties Questionnaire (SDQ) and the Mental Help Seeking Intention Scale (MHSIS).
A qualitative component, consisting of semi-structured interviews with a subset of participants will explore experiences of the programme, perceived relevance, acceptability and suggestions for refinement.
The primary purpose of this study is feasibility rather than efficacy. Findings will inform decisions about progression to a future trial, including necessary refinements to content, delivery and evaluation procedures.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Antrim, 영국
- Post Primary Schools x2
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Newtownabbey, 영국
- Post Primary Schools x 2
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Students aged 16-18 years enrolled in participating secondary schools in Northern Ireland.
- Able to provide informed consent in accordance with the approved ethics protocol.
Exclusion Criteria:
- Students who decline consent or whose parent/carer opts them out, where applicable.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention
Universal classroom-based psychoeducational programme delivered in four sessions within the school timetable.
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Four structured classroom sessions delivered by the researcher covering mental health literacy, unusual sensory experiences, psychosis awareness, stigma, and coping strategies.
Sessions involve multimedia materials, discussion, and group activities.
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간섭 없음: Control
Teaching-as-usual during data collection; students offered the intervention afterwards (waitlist).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment Feasibility
기간: Up to 3 months from recruitment opening.
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Number of students recruited and percentage of the planned recruitment target achieved, overall and by school/arm.
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Up to 3 months from recruitment opening.
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Data Collection Feasibility
기간: At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
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Proportion of enrolled students completing planned questionnaire measures at T1, T2, and T3.
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At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
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Intervention Attendance / Exposure
기간: At each intervention session and at completion of the 4-session intervention.
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Number and proportion of recruited students attending each intervention session, and number/proportion attending one or more sessions, two or more sessions, three or more sessions, and all four sessions.
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At each intervention session and at completion of the 4-session intervention.
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Fidelity to Session Structure
기간: Immediately after each intervention session.
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Proportion of planned session components delivered, assessed using researcher-completed session checklists.
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Immediately after each intervention session.
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Student-Reported Acceptability Ratings After Each Session
기간: Up to 1 week after each session.
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Ratings of acceptability, relevance, and engagement collected through brief session reflections and questionnaires, summarised descriptively.
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Up to 1 week after each session.
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Qualitative themes relating to intervention acceptability
기간: Within 8 weeks of the final intervention session.
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Themes identified through thematic analysis of semi-structured interviews with students, examining perceived acceptability, relevance, engagement, barriers and facilitators to participation, and suggestions for programme refinement.
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Within 8 weeks of the final intervention session.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Exploratory indicators of potential effectiveness
기간: At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
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Descriptive exploration of pre-post changes using repeated-measures approaches to examine patterns of change and estimate variance for planning a future definitive trial, without inferential hypothesis testing.
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At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gavin Davidson, Queen's University Belfast, School of Social Sciences, Education and Social Work
- 수석 연구원: Ciaran Shannon, Northern Health & Social Care Trust
- 수석 연구원: Ciaran Mulholland, Queen's University Belfast, School of Medicine, Dentistry and Biomedical Sciences
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- QUB_SREC_166_2324
- CDA210005 (기타 보조금/기금 번호: Health Research Board Ireland)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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