- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07627061
Integrated Motivational Interviewing and Rational Emotive Behavior Therapy Intervention for Non-Suicidal Self-Injury Among Malaysian Primary School Students: A Feasibility Trial Protocol (MIND-SET)
The Feasibility and Preliminary Effects of an Integrated Motivational Interviewing and Rational Emotive Behavior Therapy (MI-REBT) Intervention on Non-Suicidal Self-Injury, Emotional Dysregulation, and Readiness for Change Among Malaysian Primary School Students: A Trial Protocol
연구 개요
상태
상세 설명
Non-Suicidal Self-Injury (NSSI) among children and adolescents is an increasingly important mental health concern worldwide, including in Malaysia. NSSI refers to deliberate self-injurious behaviour without suicidal intent and is often associated with emotional distress, maladaptive coping, emotional dysregulation, and interpersonal difficulties. These concerns highlight the need for early, structured, and school-based intervention, particularly among primary school students who may have limited emotional regulation and help-seeking skills.
Despite increasing attention to NSSI, culturally appropriate intervention modules for Malaysian primary school students remain limited. Many existing interventions are developed within Western contexts and may not fully address the developmental, emotional, family, school, and sociocultural needs of Malaysian children. Therefore, this study introduces the MIND-SET Intervention Module, which integrates Motivational Interviewing (MI) and Rational Emotive Behavior Therapy (REBT) to support emotional regulation, cognitive restructuring, and readiness for behavioural change among students involved in NSSI behaviour.
MI is incorporated to enhance readiness for change, reduce ambivalence, and strengthen intrinsic motivation toward healthier coping behaviours. REBT is used to help participants identify irrational beliefs, challenge maladaptive thinking patterns, and develop healthier emotional and behavioural responses. The integration of MI and REBT is expected to provide a structured, supportive, and developmentally appropriate intervention for school counselling settings.
This study will employ a quasi-experimental pre-test, post-test, and follow-up design involving three groups. Approximately 105 primary school students aged 12 years from selected schools in Kedah, Malaysia, will participate in the study. Participants will be identified through school mental health screening and NSSI-related assessment procedures. The treatment group will receive the MIND-SET Intervention Module through structured group counselling sessions. The active comparator group will receive the PRISMA Mental Health Module developed by the Ministry of Education Malaysia. The treatment-as-usual group will continue receiving routine school support and normal school activities without participating in any structured intervention module during the study period.
Data will be collected at three time points: pre-intervention, post-intervention, and follow-up assessment. The study will evaluate changes in NSSI frequency, emotional dysregulation, and readiness for change using validated psychological instruments. Quantitative data analysis will be conducted to examine the feasibility and preliminary effects of the intervention across the three groups.
The findings are expected to contribute to the development of evidence-informed and culturally responsive school-based mental health interventions for Malaysian children. In addition, this study may provide practical guidance for school counsellors, educators, and policymakers in strengthening early intervention efforts related to emotional wellbeing and self-injurious behaviour among primary school students
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Charles Ganaprakasam
- 전화번호: 60164323453
- 이메일: ganaprakasamcharles@gmail.com
연구 장소
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Kedah
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Kulim, Kedah, 말레이시아, 09000
- Selected Primary Schools in Kulim District
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연락하다:
- Charles Ganaprakasam
- 전화번호: 0164323453
- 이메일: ganaprakasamcharles@gmail.com
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연락하다:
- Research Ethics Committee Universiti Utara Malaysia
- 전화번호: 604-9285299
- 이메일: ahsgservices@uum.edu.my
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수석 연구원:
- Charles Ganaprakasam
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부수사관:
- Siti Rozaina Kamsani
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부수사관:
- Nabisah Ibrahim
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Primary school students aged 12 years old.
- Students identified with Non-Suicidal Self-Injury (NSSI) behaviour through school mental health screening and assessment procedures.
- Able to understand and participate in group counselling sessions.
- Written informed consent obtained from parents or guardians.
- Assent obtained from participating students.
Exclusion Criteria:
- Students currently receiving intensive psychiatric treatment or psychological -intervention for severe mental health conditions.
- Students identified with active suicidal intent requiring immediate clinical intervention.
- Students with severe cognitive or developmental impairments that may interfere with participation in group intervention activities.
- Students who are unable to attend the scheduled intervention sessions consistently.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: MIND-SET Intervention Group
Participants in this group will receive the MIND-SET intervention module integrating Motivational Interviewing (MI) and Rational Emotive Behavior Therapy (REBT) approaches through structured group counselling sessions conducted in school settings.
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A structured school-based intervention module integrating Motivational Interviewing (MI) and Rational Emotive Behavior Therapy (REBT) approaches to reduce Non-Suicidal Self-Injury behaviour, improve emotional regulation, and enhance readiness for change among Malaysian primary school students through group counselling sessions.
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활성 비교기: Standard School Counselling Group
Participants in this group will receive the PRISMA Mental Health Module developed by the Ministry of Education Malaysia (KPM), which represents the standard structured mental health intervention currently implemented in schools.
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A structured school-based mental health intervention module developed by the Ministry of Education Malaysia (KPM) implemented as the standard care benchmark for students.
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간섭 없음: Treatment as Usual Group
Participants in this group will continue receiving routine school support and normal school activities without participating in any structured intervention module during the study period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Non-Suicidal Self-Injury Frequency
기간: Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
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Measured using the translated version of the Six-Item Non-Suicidal Self-Injury Instrument (Prinstein et al., 2010).
The instrument consists of the frequency of self-injury behavior using a 5-point scale: 0 (never), 1 (1-2 times), 2 (3-5 times), 3 (6-9 times), and 4 (10 times or more).
Scores range from 0 to 4 per item.
A higher score indicates a higher frequency of non-suicidal self-injury behavior (worse outcome).
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Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Emotional Dysregulation
기간: Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
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Measured using the Malay version of the Difficulties in Emotion Regulation Scale-18 (DERS-18), originally developed by Gratz and Roemer (2004).
The instrument consists of 18 items, with each item rated on a 5-point scale ranging from 1 (almost never) to 5 (almost always).
Total scores can range from a minimum of 18 to a maximum of 90.
A higher total score indicates a greater level of emotional dysregulation, representing a worse outcome.
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Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
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Change in Readiness for Change
기간: Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
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Measured using the translated short version of the University of Rhode Island Change Assessment (URICA-S), developed and validated by Mander et al. (2017).
The instrument contains 12 items mapping across four distinct subscales representing the Stages of Change framework: Precontemplation, Contemplation, Action, and Maintenance.
Each item is rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree).
Individual subscale scores range from 3 to 15.
A composite Readiness to Change score is calculated by summing the Contemplation, Action, and Maintenance scores, and subtracting the Precontemplation score.
Total composite scores range from a minimum of 4 to a maximum of 44, where higher scores indicate a greater readiness to change behavior (better outcome).
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Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
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공동 작업자 및 조사자
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
키워드
기타 연구 ID 번호
- UUM/CAS/AHSGS/MI-REBT-NSSI/202
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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