- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Charles Ganaprakasam
- Número de telefone: 60164323453
- E-mail: ganaprakasamcharles@gmail.com
Locais de estudo
-
-
Kedah
-
Kulim, Kedah, Malásia, 09000
- Selected Primary Schools in Kulim District
-
Contato:
- Charles Ganaprakasam
- Número de telefone: 0164323453
- E-mail: ganaprakasamcharles@gmail.com
-
Contato:
- Research Ethics Committee Universiti Utara Malaysia
- Número de telefone: 604-9285299
- E-mail: ahsgservices@uum.edu.my
-
Investigador principal:
- Charles Ganaprakasam
-
Subinvestigador:
- Siti Rozaina Kamsani
-
Subinvestigador:
- Nabisah Ibrahim
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
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.
|
|
Comparador Ativo: 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.
|
A structured school-based mental health intervention module developed by the Ministry of Education Malaysia (KPM) implemented as the standard care benchmark for students.
|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Non-Suicidal Self-Injury Frequency
Prazo: Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
|
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).
|
Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Emotional Dysregulation
Prazo: Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
|
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.
|
Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
|
|
Change in Readiness for Change
Prazo: Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
|
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).
|
Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UUM/CAS/AHSGS/MI-REBT-NSSI/202
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .