Non-Suicidal Self-InjuryMIND-SETNCT07627061
Integrated Motivational Interviewing and Rational Emotive Behavior Therapy Intervention for Non-Suicidal Self-Injury Among Malaysian Primary School Students: A Feasibility Trial Protocol
A study testing MIND-SET Intervention Module and PRISMA Mental Health Module in people with Non-Suicidal Self-Injury and Emotional Dysregulation, run by Universiti Utara Malaysia at 1 site in Malaysia.
Trial summary
This study aims to evaluate the feasibility and preliminary effects of the MIND-SET Intervention Module, an integrated Motivational Interviewing and Rational Emotive Behavior Therapy (MI-REBT) intervention, among Malaysian primary school students involved in Non-Suicidal Self-Injury (NSSI) behaviour. Read more about this study
- Who is it for?
- Ages 12 to 12 years
- Conditions the study is for
- Non-Suicidal Self-Injury, Emotional Dysregulation
- What is being tested?
- MIND-SET Intervention Module and PRISMA Mental Health Module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteMalaysia
- Study dates
- Aug 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Selected Primary Schools in Kulim District
Kulim, Kedah, 09000
Charles Ganaprakasam, 0164323453, ganaprakasamcharles@gmail.com
Research Ethics Committee Universiti Utara Malaysia, 604-9285299, ahsgservices@uum.edu.my
About this study
Official title: 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
This study aims to evaluate the feasibility and preliminary effects of the MIND-SET Intervention Module, an integrated Motivational Interviewing and Rational Emotive Behavior Therapy (MI-REBT) intervention, among Malaysian primary school students involved in Non-Suicidal Self-Injury (NSSI) behaviour. The module is designed to reduce self-injurious behaviour, improve emotional regulation, and enhance readiness for change among 12-year-old students in school settings. This study will use a quasi-experimental design involving three groups: a MIND-SET intervention group, a PRISMA Mental Health Module group, and a treatment-as-usual group. Data will be collected at pre-intervention, post-intervention, and follow-up stages using validated psychological instruments. The findings are expected to support the development of culturally responsive, school-based mental health interventions for children involved in NSSI behaviour in Malaysia.
Read the detailed description
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
- Conditions
- Non-Suicidal Self-Injury, Emotional Dysregulation
- Being tested
- MIND-SET Intervention Module, PRISMA Mental Health Module
- Keywords
- Non-suicidal self-injury, NSSI, Primary school students, Children, Emotional dysregulation, Readiness for change, Motivational Interviewing, Rational Emotive Behavior Therapy, School counselling, Malaysia, MIND-SET Intervention Module
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIND-SET Intervention ModuleBehavioural
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.
PRISMA Mental Health ModuleBehavioural
A structured school-based mental health intervention module developed by the Ministry of Education Malaysia (KPM) implemented as the standard care benchmark for students.
| Study group | Role | What they receive |
|---|---|---|
| MIND-SET Intervention Group | Experimental | 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. Receives: Behavioral: MIND-SET Intervention Module |
| Standard School Counselling Group | Active comparator | 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. Receives: Behavioral: PRISMA Mental Health Module |
| Treatment as Usual Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Non-Suicidal Self-Injury Frequency
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).
Measured: Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
Secondary outcomes (2)
Change in Emotional Dysregulation
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.
Measured: Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
Change in Readiness for Change
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).
Measured: Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Suicidal Self-InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned into three groups consisting of one treatment group and two control groups. The treatment group will receive the MIND-SET intervention module integrating Motivational Interviewing and Rational Emotive Behavior Therapy approaches, while the control groups will receive standard school counselling intervention or no intervention. Outcomes will be assessed across pre-test, post-test, and follow-up phases.
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Utara Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Malaysia
- Responsible party
- Principal investigator, Charles A/L Ganaprakasam, Universiti Utara Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627061
- Sponsor's protocol ID
- UUM/CAS/AHSGS/MI-REBT-NSSI/202
- Acronym
- MIND-SET
- Status last verified
- May 2026
- First submitted
- 23 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) generated during this study involve highly sensitive psychological and behavioral information from primary school students, including Non-Suicidal Self-Injury (NSSI)-related data. Due to strict ethical considerations, participant confidentiality protection, and institutional data protection policies, individual participant data sets will not be made publicly available to external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07627061
- Acronym / sponsor ID
- MIND-SET / UUM/CAS/AHSGS/MI-REBT-NSSI/202
- Conditions
- Non-Suicidal Self-Injury, Emotional Dysregulation
- Keywords
- Non-suicidal self-injury, NSSI, Primary school students, Children, Emotional dysregulation, Readiness for change, Motivational Interviewing, Rational Emotive Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Universiti Utara MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Education, Malaysia
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the feasibility and preliminary effects of the MIND-SET Intervention Module, an integrated Motivational Interviewing and Rational Emotive Behavior Therapy (MI-REBT) intervention, among Malaysian primary school students involved in Non-Suicidal Self-Injury (NSSI) behaviour. The module is designed to reduce self-injurious behaviour, improve emotional regulation, and enhance readiness for change among 12-year-old students in school settings. This study will use a quasi-experimental design involving three groups: a MIND-SET intervention group, a PRISMA Mental Health Module group, and a treatment-as-usual group. Data will be collected at pre-intervention, post-intervention, and follow-up stages using validated psychological instruments. The findings are expected to support the development of culturally responsive, school-based mental health interventions for children involved in NSSI behaviour in Malaysia.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be assigned into three groups consisting of one treatment group and two control groups. The treatment group will receive the MIND-SET intervention module integrating Motivational Interviewing and Rational Emotive Behavior Therapy approaches, while the control groups will receive standard school counselling intervention or no intervention. Outcomes will be assessed across pre-test, post-test, and follow-up phases.
| Arm | Type | Receives |
|---|---|---|
| MIND-SET Intervention Group | Experimental | Behavioral: MIND-SET Intervention ModuleParticipants 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. |
| Standard School Counselling Group | Active comparator | Behavioral: PRISMA Mental Health ModuleParticipants 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. |
| Treatment as Usual Group | No intervention | –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. |
Who may qualify
- Ages
- 12 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIND-SET Intervention ModuleA 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. | Behavioural | MIND-SET Intervention Group |
| PRISMA Mental Health ModuleA structured school-based mental health intervention module developed by the Ministry of Education Malaysia (KPM) implemented as the standard care benchmark for students. | Behavioural | Standard School Counselling Group |
Primary outcome
Change in Non-Suicidal Self-Injury Frequency
Time frame: 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).
2 secondary outcomes
Change in Emotional Dysregulation
Time frame: Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
Change in Readiness for Change
Time frame: Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) generated during this study involve highly sensitive psychological and behavioral information from primary school students, including Non-Suicidal Self-Injury (NSSI)-related data. Due to strict ethical considerations, participant confidentiality protection, and institutional data protection policies, individual participant data sets will not be made publicly available to external researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIND-SET Intervention Module and PRISMA Mental Health Module in people with Non-Suicidal Self-Injury and Emotional Dysregulation, run by Universiti Utara Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Ganaprakasam (60164323453, ganaprakasamcharles@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Non-Suicidal Self-Injury Frequency (time frame: Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.